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Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue contour collapse. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue contour and to maintain long term stability is unclear. Purpose : The aim of this study is to evaluate the volumetric difference of buccal soft tissue contour as well as the radiographic changes, following tooth extraction and immediate implant placement with dual zone concept versus connective tissue graft. Materials and Methods: Thirty patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 15 patient in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with particulate bone grafts in the dual zone (the bone zone and the tissue zone) and customized healing abutment. Group 2 (control group) IIP with connective tissue graft (CTG) and customized healing abutment. Patient allocation is random for the 2 groups. Data will be collected pre-surgically and at follow up periods (3,6,9&12 months and 6 months after delivery). Extra-oral scanning of the labial contour will be carried out to evaluate difference in contour gained and will be compared to the original contour and between treatment groups. Radiographic evaluation will be done using CBCT pre-operatively and at 12 months.
After administration of local anaesthesia, the tooth will be extracted by the principle investigator without raising flaps, as atraumatically as possible by using periotomes without disturbing the papillary tissues (minimal traumatic extraction technique). After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions. The allocation will be revealed to the principle investigator for the 3 implant groups after implant placement.
Group 1: extraction will occur and then followed by immediate implant placement,using standard implant system protocol preparation of the osteotomy will take place. Initial drill will be placed palatally till final drill reached. Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm (37). Particulate bone grafts are packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), Followed by customized healing abutment, the temporary cylindrical abutment twill be screwed to the implant and then flowable composite will be injected at the gingival margin level to adapt to the abutment that will be sand-blasted previously for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva, but will only seal the socket without extending deeper apically in the soft tissue. A buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will then be screwed to the implant with the correct torque.
Group 2: Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place, then will be covered by a customized healing abutment that will be done as mentioned before.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual zone concept and customized healing abutment | Experimental | Immediate implant placement with bone grafts in the dual zone and customized healing abutment. |
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| Connective tissue graft and customized healing abutment | Active Comparator | immediate implant placement with CTG and customized healing abutment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connective tissue graft and customized healing abutment | Procedure | Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant. |
| Measure | Description | Time Frame |
|---|---|---|
| Pink Esthetic Score (PES) | The PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture. The peri-implant mucosa will be evaluated by the seven index points. The grading using the PES suggested by Fürhauser will be performed. The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value (Fürhauser et al., 2005). | 6 months after delivery (18 months after IIP) |
| Measure | Description | Time Frame |
|---|---|---|
| Bucco-palatal width | Measured with CBCT | Before surgery - 12 months |
| Gingival thickness | Measured with periodontal probe | Before surgery - 6 months - 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed I Abo El Futtouh, Master | Clinical Director of Implant Program - Misr International University | Principal Investigator |
| Khaled Abdel-Ghaffar, Professor | Minister of Higher Education and Scientific Research | Study Director |
| Inas S Hanna, Bsc | Dentist/Researcher - IDCE | Study Director |
| Nael A Mina, Bsc | Misr International University | Study Chair |
| Abdel Rahman A Abdel Rahman, Master | International Dental Contiuing Education | Study Chair |
| Ahmed F Mostafa, Bsc | International Dental Contiuing Education | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Dental Contining Education Centre (IDCE) | Cairo | Egypt | ||||
| Misr International University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28402349 | Result | Gluckman H, Salama M, Du Toit J. Partial Extraction Therapies (PET) Part 2: Procedures and Technical Aspects. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):377-385. doi: 10.11607/prd.3111. | |
| 25434568 | Result | Fuentealba R, Jofre J. Esthetic failure in implant dentistry. Dent Clin North Am. 2015 Jan;59(1):227-46. doi: 10.1016/j.cden.2014.08.006. Epub 2014 Sep 26. |
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All data can be shared
One year
Principal investigator
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• To compare the volumetric changes in the buccal soft tissue contour between immediate implants with CTG and customized healing abutments, and immediate implants with bone grafting in the dual zone and customized healing abutmnets
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| Dual zone concept and customized healing abutment | Procedure | Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Followed by bone grafting following dual zone concept and customized healing abutment. |
|
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| Mid facial recession to assess the changes in tissue level | Measured with 3D Viewer software | Before surgery - 3 months - 6 months - 9 months - 12 months |
| Interdental papillae height to assess changes in papilla height | Measured with 3D Viewer software | Before surgery - 3 months - 6 months - 9 months - 12 months |
| Modified Plaque Index | Measured with Periodontal probe | 3 months - 6 months - 9 months - 12 months |
| Modified Bleeding Index | Measured with Periodontal probe | 3 months - 6 months - 9 months - 12 months |
| Patient satisfaction | Measured with Visual Analogue Scale (VAS). The patients will mark their satisfaction in a non-numerical 100 mm line ranging from "not at all satisfied=0" (left) to "very satisfied=100" (right), for each implant | 12 months |
| Volumetric analysis of buccal contour to assess changes in buccal countour | Measured with Extra oral scanning + 3D viewer software | Before surgery - 3 months - 6 months - 9 months - 12 months |
| Cairo |
| Egypt |
| 20467628 | Result | Esposito M, Grusovin MG, Felice P, Karatzopoulos G, Worthington HV, Coulthard P. The efficacy of horizontal and vertical bone augmentation procedures for dental implants - a Cochrane systematic review. Eur J Oral Implantol. 2009 Autumn;2(3):167-84. |
| 24660198 | Result | Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3. |
| 15635945 | Result | Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61. |
| 15839587 | Result | Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9. |
| 15691354 | Result | Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x. |
| 17092218 | Result | Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Tissue modeling following implant placement in fresh extraction sockets. Clin Oral Implants Res. 2006 Dec;17(6):615-24. doi: 10.1111/j.1600-0501.2006.01317.x. |
| 19885446 | Result | Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217. |
| 22814758 | Result | Horvath A, Mardas N, Mezzomo LA, Needleman IG, Donos N. Alveolar ridge preservation. A systematic review. Clin Oral Investig. 2013 Mar;17(2):341-63. doi: 10.1007/s00784-012-0758-5. Epub 2012 Jul 20. |
| 26022542 | Result | Masaki C, Nakamoto T, Mukaibo T, Kondo Y, Hosokawa R. Strategies for alveolar ridge reconstruction and preservation for implant therapy. J Prosthodont Res. 2015 Oct;59(4):220-8. doi: 10.1016/j.jpor.2015.04.005. Epub 2015 May 26. |
| 27007188 | Result | De Risi V, Clementini M, Vittorini G, Mannocci A, De Sanctis M. Alveolar ridge preservation techniques: a systematic review and meta-analysis of histological and histomorphometrical data. Clin Oral Implants Res. 2015 Jan;26(1):50-68. doi: 10.1111/clr.12288. Epub 2013 Nov 1. |
| 29641631 | Result | Luckerath W, Roder L, Enkling N. The Effect of Primary Stabilization of the Graft in a Combined Surgical and Prosthodontic Ridge Preservation Protocol: A Prospective Controlled Clinical Pilot Study. Int J Periodontics Restorative Dent. 2018 May/Jun;38(3):e49-e58. doi: 10.11607/prd.3172. |
| 11405020 | Result | Kan JY, Rungcharassaeng K. Immediate placement and provisionalization of maxillary anterior single implants: a surgical and prosthodontic rationale. Pract Periodontics Aesthet Dent. 2000 Nov-Dec;12(9):817-24; quiz 826. |
| 29478284 | Result | Kan JYK, Rungcharassaeng K, Deflorian M, Weinstein T, Wang HL, Testori T. Immediate implant placement and provisionalization of maxillary anterior single implants. Periodontol 2000. 2018 Jun;77(1):197-212. doi: 10.1111/prd.12212. Epub 2018 Feb 25. |
| 24804283 | Result | Tarnow DP, Chu SJ, Salama MA, Stappert CF, Salama H, Garber DA, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Saito H. Flapless postextraction socket implant placement in the esthetic zone: part 1. The effect of bone grafting and/or provisional restoration on facial-palatal ridge dimensional change-a retrospective cohort study. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):323-31. doi: 10.11607/prd.1821. |
| 26509983 | Result | Chu SJ, Salama MA, Garber DA, Salama H, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Reynolds MA, Saito H, Tarnow DP. Flapless Postextraction Socket Implant Placement, Part 2: The Effects of Bone Grafting and Provisional Restoration on Peri-implant Soft Tissue Height and Thickness- A Retrospective Study. Int J Periodontics Restorative Dent. 2015 Nov-Dec;35(6):803-9. doi: 10.11607/prd.2178. |
| 29889914 | Result | Chu SJ, Saito H, Salama MA, Garber DA, Salama H, Sarnachiaro GO, Reynolds MA, Tarnow DP. Flapless Postextraction Socket Implant Placement, Part 3: The Effects of Bone Grafting and Provisional Restoration on Soft Tissue Color Change-A Retrospective Pilot Study. Int J Periodontics Restorative Dent. 2018 Jul/Aug;38(4):509-516. doi: 10.11607/prd.3571. |
| 27475245 | Result | Akin R. A New Concept in Maintaining the Emergence Profile in Immediate Posterior Implant Placement: The Anatomic Harmony Abutment. J Oral Maxillofac Surg. 2016 Dec;74(12):2385-2392. doi: 10.1016/j.joms.2016.06.184. Epub 2016 Jul 1. |
| Result | Janakievski J. Case Report : Maintenance of Gingival Form Following Immediate Implant Placement - The Custom-Healing Abutment. Adv Esthet Interdiscip Dent. 2007;3(4):4-7 |
| Result | Mihali S. Maintaining Tissue Architecture in Immediate Implant Placement Following Extraction of Natural Teeth Using Custom Healing Screw. Biomed J Sci Tech Res. 2018 |
| 28941303 | Result | Zuiderveld EG, Meijer HJA, den Hartog L, Vissink A, Raghoebar GM. Effect of connective tissue grafting on peri-implant tissue in single immediate implant sites: A RCT. J Clin Periodontol. 2018 Feb;45(2):253-264. doi: 10.1111/jcpe.12820. Epub 2017 Dec 5. |
| 19835749 | Result | Kan JY, Rungcharassaeng K, Morimoto T, Lozada J. Facial gingival tissue stability after connective tissue graft with single immediate tooth replacement in the esthetic zone: consecutive case report. J Oral Maxillofac Surg. 2009 Nov;67(11 Suppl):40-8. doi: 10.1016/j.joms.2009.07.004. |
| 26743894 | Result | Kolerman R, Nissan J, Mijiritsky E, Hamoudi N, Mangano C, Tal H. Esthetic assessment of immediately restored implants combined with GBR and free connective tissue graft. Clin Oral Implants Res. 2016 Nov;27(11):1414-1422. doi: 10.1111/clr.12755. Epub 2016 Jan 7. |