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| Name | Class |
|---|---|
| Nobel Biocare | INDUSTRY |
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The aim of this study was to evaluate the effects of definitive abutment connection at the time of implant placement on peri-implant bone levels and soft tissue changes in posterior maxilla and mandible regions.
A total of 38 implants were placed in 17 patients with at least 2 missing posterior teeth in the maxilla or the mandible for this study. Each patient received 2 or 4 implants. A definitive prefabricated abutment (test group) was randomly connected to one implant at implant placement (T0) and left undisturbed throughout the duration of the study. On the other implant, a healing abutment (control group) was connected and subjected to go through three disconnections and reconnections at 3 months (T3), 6 months (T6), and 12 months (T12) after the implant placement. Throughout the study period (1 year), all implants remained unrestored. Marginal bone level changes (MBLC) were assessed using standardized periapical radiographs taken at T0 and T12. Peri-implant soft tissue parameters including the keratinized mucosa width and lingual mucosa thickness were also recorded and evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Split mouth: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the study | |
| Test group | Experimental | Split mouth: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definitive abutment | Device | With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up | Standardized digital periapical radiographs were taken at baseline (implant placement) and at the 1-year follow-up using the long-cone paralleling technique with a custom jig. Peri-implant marginal bone levels were measured on both the mesial and distal aspects to assess bone loss. Changes in peri-implant marginal bone levels were calculated by comparing the measurements at the 1-year follow-up to the baseline values. | At baseline (implant placement) and 1 year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Keratinized Mucosa Width | The width of the keratinized mucosa was measured at the mid-buccal aspect of the abutments using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values. | At baseline (implant placement) and 1 year follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Kan, DDS, MS | Loma Linda University School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University, School of Dentistry | Loma Linda | California | 92350 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9151585 | Background | Abrahamsson I, Berglundh T, Wennstrom J, Lindhe J. The peri-implant hard and soft tissues at different implant systems. A comparative study in the dog. Clin Oral Implants Res. 1996 Sep;7(3):212-9. doi: 10.1034/j.1600-0501.1996.070303.x. | |
| 1809403 | Background | Berglundh T, Lindhe J, Ericsson I, Marinello CP, Liljenberg B, Thomsen P. The soft tissue barrier at implants and teeth. Clin Oral Implants Res. 1991 Apr-Jun;2(2):81-90. doi: 10.1034/j.1600-0501.1991.020206.x. |
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19 participants were initially enrolled. 2 participants withdrew: one moved away during the COVID-19 pandemic, and another agreed to participate and signed the consent form but later withdrew due to being unable to attend the scheduled surgery.
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control group: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnections and reconnections during 1 year follow-up before implant restoration procedures. |
| FG001 | Test Group | Test group: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during 1 year follow-up before implant restoration procedures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Split Mouth Subject | Control group: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the prosthetic phase Test group: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase Definitive abutment: With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up | Standardized digital periapical radiographs were taken at baseline (implant placement) and at the 1-year follow-up using the long-cone paralleling technique with a custom jig. Peri-implant marginal bone levels were measured on both the mesial and distal aspects to assess bone loss. Changes in peri-implant marginal bone levels were calculated by comparing the measurements at the 1-year follow-up to the baseline values. | Posted | Mean | Standard Deviation | millimeters | At baseline (implant placement) and 1 year follow up | Implants | Implants |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Split mouth: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sasiya Bhumpattarachai | Loma Linda University, School of Dentistry | 6267565156 | sbhumpattarachai@llu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2024 | Sep 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single center, prospective, randomized modified split mouth clinical trial
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|
|
| Changes in Lingual Mucosa Thickness |
The thickness of the lingual mucosa at each implant site was measured at the center of the implant site from the bone crest using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values taken on the day of implant surgery. |
| At baseline (implant placement) and 1 year follow up |
| Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP) | Success was determined by the implant's ability to meet these clinical factors, such as the absence of pain, infection, mobility, and radiographic bone loss beyond the acceptable threshold of the follow-up period, as assessed at 12 months post-surgical implantation. | 12 months after surgical implantation |
| 8915028 | Background | Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x. |
| 6459440 | Background | Squier CA, Collins P. The relationship between soft tissue attachment, epithelial downgrowth and surface porosity. J Periodontal Res. 1981 Jul;16(4):434-40. doi: 10.1111/j.1600-0765.1981.tb00994.x. No abstract available. |
| 1601902 | Background | Chehroudi B, Gould TR, Brunette DM. The role of connective tissue in inhibiting epithelial downgrowth on titanium-coated percutaneous implants. J Biomed Mater Res. 1992 Apr;26(4):493-515. doi: 10.1002/jbm.820260407. |
| 7790533 | Background | Ericsson I, Persson LG, Berglundh T, Marinello CP, Lindhe J, Klinge B. Different types of inflammatory reactions in peri-implant soft tissues. J Clin Periodontol. 1995 Mar;22(3):255-61. doi: 10.1111/j.1600-051x.1995.tb00143.x. |
| 12598555 | Background | Broggini N, McManus LM, Hermann JS, Medina RU, Oates TW, Schenk RK, Buser D, Mellonig JT, Cochran DL. Persistent acute inflammation at the implant-abutment interface. J Dent Res. 2003 Mar;82(3):232-7. doi: 10.1177/154405910308200316. |
| 22834397 | Background | Rompen E. The impact of the type and configuration of abutments and their (repeated) removal on the attachment level and marginal bone. Eur J Oral Implantol. 2012;5 Suppl:S83-90. |
| 9266344 | Background | Abrahamsson I, Berglundh T, Lindhe J. The mucosal barrier following abutment dis/reconnection. An experimental study in dogs. J Clin Periodontol. 1997 Aug;24(8):568-72. doi: 10.1111/j.1600-051x.1997.tb00230.x. |
| 22676071 | Background | Becker K, Mihatovic I, Golubovic V, Schwarz F. Impact of abutment material and dis-/re-connection on soft and hard tissue changes at implants with platform-switching. J Clin Periodontol. 2012 Aug;39(8):774-80. doi: 10.1111/j.1600-051X.2012.01911.x. Epub 2012 Jun 7. |
| 22092773 | Background | Rodriguez X, Vela X, Mendez V, Segala M, Calvo-Guirado JL, Tarnow DP. The effect of abutment dis/reconnections on peri-implant bone resorption: a radiologic study of platform-switched and non-platform-switched implants placed in animals. Clin Oral Implants Res. 2013 Mar;24(3):305-11. doi: 10.1111/j.1600-0501.2011.02317.x. Epub 2011 Oct 3. |
| 24735458 | Background | Alves CC, Munoz F, Cantalapiedra A, Ramos I, Neves M, Blanco J. Marginal bone and soft tissue behavior following platform switching abutment connection/disconnection--a dog model study. Clin Oral Implants Res. 2015 Sep;26(9):983-91. doi: 10.1111/clr.12385. Epub 2014 Apr 16. |
| 21985288 | Background | Degidi M, Nardi D, Piattelli A. One abutment at one time: non-removal of an immediate abutment and its effect on bone healing around subcrestal tapered implants. Clin Oral Implants Res. 2011 Nov;22(11):1303-7. doi: 10.1111/j.1600-0501.2010.02111.x. Epub 2011 Feb 24. |
| 23458566 | Background | Degidi M, Nardi D, Daprile G, Piattelli A. Nonremoval of immediate abutments in cases involving subcrestally placed postextractive tapered single implants: a randomized controlled clinical study. Clin Implant Dent Relat Res. 2014 Dec;16(6):794-805. doi: 10.1111/cid.12051. Epub 2013 Mar 4. |
| 21180681 | Background | Canullo L, Bignozzi I, Cocchetto R, Cristalli MP, Iannello G. Immediate positioning of a definitive abutment versus repeated abutment replacements in post-extractive implants: 3-year follow-up of a randomised multicentre clinical trial. Eur J Oral Implantol. 2010 Winter;3(4):285-96. |
| 22518376 | Background | Grandi T, Guazzi P, Samarani R, Garuti G. Immediate positioning of definitive abutments versus repeated abutment replacements in immediately loaded implants: effects on bone healing at the 1-year follow-up of a multicentre randomised controlled trial. Eur J Oral Implantol. 2012 Spring;5(1):9-16. |
| 24550840 | Background | Berberi AN, Sabbagh JM, Aboushelib MN, Noujeim ZF, Salameh ZA. A 5-year comparison of marginal bone level following immediate loading of single-tooth implants placed in healed alveolar ridges and extraction sockets in the maxilla. Front Physiol. 2014 Jan 31;5:29. doi: 10.3389/fphys.2014.00029. eCollection 2014. |
| 24977249 | Background | Grandi T, Guazzi P, Samarani R, Maghaireh H, Grandi G. One abutment-one time versus a provisional abutment in immediately loaded post-extractive single implants: a 1-year follow-up of a multicentre randomised controlled trial. Eur J Oral Implantol. 2014 Summer;7(2):141-9. |
| 27016157 | Background | Molina A, Sanz-Sanchez I, Martin C, Blanco J, Sanz M. The effect of one-time abutment placement on interproximal bone levels and peri-implant soft tissues: a prospective randomized clinical trial. Clin Oral Implants Res. 2017 Apr;28(4):443-452. doi: 10.1111/clr.12818. Epub 2016 Mar 25. |
| 23748313 | Background | Koutouzis T, Koutouzis G, Gadalla H, Neiva R. The effect of healing abutment reconnection and disconnection on soft and hard peri-implant tissues: a short-term randomized controlled clinical trial. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):807-14. doi: 10.11607/jomi.3022. |
| 26021224 | Background | Luongo G, Bressan E, Grusovin MG, d'Avenia F, Neumann K, Sbricoli L, Esposito M. Do repeated changes of abutments have any influence on the stability of peri-implant tissues? Four-month post-loading preliminary results from a multicentre randomised controlled trial. Eur J Oral Implantol. 2015 Summer;8(2):129-40. |
| 24612047 | Background | Iglhaut G, Schwarz F, Winter RR, Mihatovic I, Stimmelmayr M, Schliephake H. Epithelial attachment and downgrowth on dental implant abutments--a comprehensive review. J Esthet Restor Dent. 2014 Sep-Oct;26(5):324-31. doi: 10.1111/jerd.12097. Epub 2014 Mar 11. |
| 2691661 | Background | Smith DE, Zarb GA. Criteria for success of osseointegrated endosseous implants. J Prosthet Dent. 1989 Nov;62(5):567-72. doi: 10.1016/0022-3913(89)90081-4. |
| 3507627 | Background | Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available. |
| 19885413 | Background | Linkevicius T, Apse P, Grybauskas S, Puisys A. The influence of soft tissue thickness on crestal bone changes around implants: a 1-year prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):712-9. |
| 8038340 | Background | Wennstrom JL, Bengazi F, Lekholm U. The influence of the masticatory mucosa on the peri-implant soft tissue condition. Clin Oral Implants Res. 1994 Mar;5(1):1-8. doi: 10.1034/j.1600-0501.1994.050101.x. |
| 24313250 | Background | Puisys A, Linkevicius T. The influence of mucosal tissue thickening on crestal bone stability around bone-level implants. A prospective controlled clinical trial. Clin Oral Implants Res. 2015 Feb;26(2):123-9. doi: 10.1111/clr.12301. Epub 2013 Dec 9. |
| 24147913 | Background | Schwarz F, Alcoforado G, Nelson K, Schaer A, Taylor T, Beuer F, Strietzel FP. Impact of implant-abutment connection, positioning of the machined collar/microgap, and platform switching on crestal bone level changes. Camlog Foundation Consensus Report. Clin Oral Implants Res. 2014 Nov;25(11):1301-1303. doi: 10.1111/clr.12269. Epub 2013 Oct 21. |
| 23782338 | Background | Schwarz F, Hegewald A, Becker J. Impact of implant-abutment connection and positioning of the machined collar/microgap on crestal bone level changes: a systematic review. Clin Oral Implants Res. 2014 Apr;25(4):417-25. doi: 10.1111/clr.12215. Epub 2013 Jun 18. |
| 20507379 | Background | Schwarz F, Mihatovic I, Ferrari D, Wieland M, Becker J. Influence of frequent clinical probing during the healing phase on healthy peri-implant soft tissue formed at different titanium implant surfaces: a histomorphometrical study in dogs. J Clin Periodontol. 2010 Jun;37(6):551-62. doi: 10.1111/j.1600-051X.2010.01568.x. |
| 25175742 | Background | Schwarz F, Mihatovic I, Golubovich V, Schar A, Sager M, Becker J. Impact of abutment microstructure and insertion depth on crestal bone changes at nonsubmerged titanium implants with platform switch. Clin Oral Implants Res. 2015 Mar;26(3):287-92. doi: 10.1111/clr.12478. Epub 2014 Aug 30. |
| 9763327 | Background | Abrahamsson I, Berglundh T, Glantz PO, Lindhe J. The mucosal attachment at different abutments. An experimental study in dogs. J Clin Periodontol. 1998 Sep;25(9):721-7. doi: 10.1111/j.1600-051x.1998.tb02513.x. |
| 18492075 | Background | Welander M, Abrahamsson I, Berglundh T. The mucosal barrier at implant abutments of different materials. Clin Oral Implants Res. 2008 Jul;19(7):635-41. doi: 10.1111/j.1600-0501.2008.01543.x. Epub 2008 May 19. |
| 16515092 | Background | Lazzara RJ, Porter SS. Platform switching: a new concept in implant dentistry for controlling postrestorative crestal bone levels. Int J Periodontics Restorative Dent. 2006 Feb;26(1):9-17. |
| 25678247 | Background | Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11. |
| 30246409 | Background | Souza AB, Alshihri A, Kammerer PW, Araujo MG, Gallucci GO. Histological and micro-CT analysis of peri-implant soft and hard tissue healing on implants with different healing abutments configurations. Clin Oral Implants Res. 2018 Oct;29(10):1007-1015. doi: 10.1111/clr.13367. Epub 2018 Sep 23. |
| 33226676 | Background | Lambrechts T, Doornewaard R, De Bruyckere T, Matthijs L, Deschepper E, Cosyn J. A multicenter cohort study on the association of the one-abutment one-time concept with marginal bone loss around bone level implants. Clin Oral Implants Res. 2021 Feb;32(2):192-202. doi: 10.1111/clr.13689. Epub 2020 Dec 20. |
| 35011814 | Background | Hamudi N, Barnea E, Weinberg E, Laviv A, Mijiritsky E, Matalon S, Chaushu L, Kolerman R. The Association of the One-Abutment at One-Time Concept with Marginal Bone Loss around the SLA and Platform Switch and Conical Abutment Implants. J Clin Med. 2021 Dec 24;11(1):74. doi: 10.3390/jcm11010074. |
| 38842070 | Background | Jiang J, Yang H, Zhu H, Bouhamed IEK, Shen X, Lu H, He F. Clinical efficacy of a two-piece abutment conforming to the concept of one abutment one time in the posterior region: A clinical pilot study. Clin Implant Dent Relat Res. 2024 Aug;26(4):763-776. doi: 10.1111/cid.13349. Epub 2024 Jun 6. |
| 39011816 | Background | Calatrava J, Sanz-Sanchez I, Molina A, Bollain J, Martin C, Sanz M. Effect of one-time placement of the definitive abutment versus multiple healing abutment disconnections and reconnections during the prosthetic phase on radiographic and clinical outcomes: A 12-month randomized clinical trial. Clin Implant Dent Relat Res. 2024 Oct;26(5):998-1011. doi: 10.1111/cid.13361. Epub 2024 Jul 16. |
| 31925984 | Background | Praca LFG, Teixeira RC, Rego RO. Influence of abutment disconnection on peri-implant marginal bone loss: A randomized clinical trial. Clin Oral Implants Res. 2020 Apr;31(4):341-351. doi: 10.1111/clr.13572. Epub 2020 Jan 27. |
| 33348644 | Background | Rios-Santos JV, Tello-Gonzalez G, Lazaro-Calvo P, Gil Mur FJ, Rios-Carrasco B, Fernandez-Palacin A, Herrero-Climent M. One Abutment One Time: A Multicenter, Prospective, Controlled, Randomized Study. Int J Environ Res Public Health. 2020 Dec 17;17(24):9453. doi: 10.3390/ijerph17249453. |
| 34361372 | Background | Moreira F, Rocha S, Caramelo F, Tondela JP. One-Abutment One-Time Effect on Peri-Implant Marginal Bone: A Prospective, Controlled, Randomized, Double-Blind Study. Materials (Basel). 2021 Jul 27;14(15):4179. doi: 10.3390/ma14154179. |
| 38506392 | Background | Sanz-Sanchez I, Molina A, Martin C, Bollain J, Calatrava J, Sanz M. The effect of one-time abutment placement on clinical and radiographic outcomes: A 5-year randomized clinical trial. Clin Oral Implants Res. 2024 Jun;35(6):609-620. doi: 10.1111/clr.14256. Epub 2024 Mar 20. |
| 31815968 | Background | Canullo L, Tallarico M, Gracis S, Vela X, Rodriguez X, Covani U. Clinical Considerations on Strategies That Avoid Multiple Connections and Disconnections of Implant Abutments. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):9-17. doi: 10.11607/prd.3642. |
| 34642986 | Background | Pommer B, Danzinger M, Leite Aiquel L, Pitta J, Haas R. Long-term outcomes of maxillary single-tooth implants in relation to timing protocols of implant placement and loading: Systematic review and meta-analysis. Clin Oral Implants Res. 2021 Oct;32 Suppl 21:56-66. doi: 10.1111/clr.13838. |
| 34528906 | Background | Vatenas I, Linkevicius T. One abutment one time vs. repeatable abutment disconnections in implants, restored with cemented / screw retained fixed partial dentures: Marginal bone level changes. A systematic review and meta-analysis. Stomatologija. 2021;23(2):35-40. |
| 37253247 | Background | Kang Y, Zheng X, Zhang D, Li S, Xu S, Chen L, Zhang Z, Lin X. One-Abutment at One-Time in Posterior Edentulism: A Systematic Review and Meta-Analysis. J Craniofac Surg. 2023 Nov-Dec 01;34(8):e720-e724. doi: 10.1097/SCS.0000000000009428. Epub 2023 May 29. |
| 28334059 | Background | Koutouzis T, Gholami F, Reynolds J, Lundgren T, Kotsakis GA. Abutment Disconnection/Reconnection Affects Peri-implant Marginal Bone Levels: A Meta-Analysis. Int J Oral Maxillofac Implants. 2017 May/June;32(3):575-581. doi: 10.11607/jomi.5367. Epub 2017 Mar 23. |
| 28923270 | Background | Tallarico M, Caneva M, Meloni SM, Xhanari E, Covani U, Canullo L. Definitive Abutments Placed at Implant Insertion and Never Removed: Is It an Effective Approach? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2018 Feb;76(2):316-324. doi: 10.1016/j.joms.2017.08.025. Epub 2017 Aug 24. |
| 31535098 | Background | de Carvalho Barbara JG, Luz D, Vianna K, Porto Barboza E. The influence of abutment disconnections on peri-implant marginal bone: A systematic review. Int J Oral Implantol (Berl). 2019;12(3):283-296. |
| 35723484 | Background | De Pascalis F. Soft tissue integration with a hybrid abutment using the "one abutment-one time" therapeutic protocol: case series. Quintessence Int. 2022 Jun 20;53(7):590-596. doi: 10.3290/j.qi.b3082565. |
| 36068381 | Background | Waltenberger L, Wolfart S. SafetyCrown: a patient-centered, fully digital concept for immediate implant restoration following the one-abutment/one-time concept-a pilot case series of a new treatment concept. Int J Implant Dent. 2022 Sep 6;8(1):35. doi: 10.1186/s40729-022-00434-2. |
| 37013667 | Background | Reis INRD, Todescan FF, Ruiz GM, da Silva EVF, Romito GA, Spin-Neto R, Pannuti CM. Influence of supracrestal tissue height on peri-implant hard and soft tissues of single implants placed in the esthetic area using the one abutment-one time approach: a 1-year prospective interventional study. Quintessence Int. 2023 Jul 17;54(7):536-547. doi: 10.3290/j.qi.b4009377. |
| 37847836 | Background | Henao PAR, Queija LC, Linder S, Dard M, Gonzalez AL, Carrion JB. Clinical and Radiographic Outcomes of a New Fully Tapered Implant with the One-Abutment One-Time Approach: In-Line Clinical Case Series with a 1-Year Follow-up. Int J Oral Maxillofac Implants. 2023 Oct 17;38(5):943-953. doi: 10.11607/jomi.10276. |
| 38600003 | Background | Ibrahim AM, Elgamal M, Ragheb NA. One-time definitive attachment connection versus healing abutment placement for an implant-retained mandibular overdenture: Peri-implant metabolic activity. J Prosthet Dent. 2024 Oct;132(4):782.e1-782.e7. doi: 10.1016/j.prosdent.2024.03.008. Epub 2024 Apr 10. |
| 39005091 | Background | Wang YM, He JC. [Short-term follow up of treatment effect using one-time one-abutment placement in implant restoration in 35 patients with single posterior teeth loss]. Shanghai Kou Qiang Yi Xue. 2024 Apr;33(2):156-159. Chinese. |
| Implants |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Test Group |
Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase Definitive abutment: With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures |
|
|
|
| Secondary | Changes in Keratinized Mucosa Width | The width of the keratinized mucosa was measured at the mid-buccal aspect of the abutments using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values. | Posted | Mean | Standard Deviation | millimeters | At baseline (implant placement) and 1 year follow up | Implants | Implants |
|
|
|
|
| Secondary | Changes in Lingual Mucosa Thickness | The thickness of the lingual mucosa at each implant site was measured at the center of the implant site from the bone crest using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values taken on the day of implant surgery. | Posted | Mean | Standard Deviation | millimeters | At baseline (implant placement) and 1 year follow up | Implants | Implants |
|
|
|
|
| Secondary | Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP) | Success was determined by the implant's ability to meet these clinical factors, such as the absence of pain, infection, mobility, and radiographic bone loss beyond the acceptable threshold of the follow-up period, as assessed at 12 months post-surgical implantation. | Posted | Count of Units | Implants | 12 months after surgical implantation | Implants | Implants |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Test Group | Split mouth: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase Definitive abutment: With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |