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The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.
This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest.
Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4.
A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method.
The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement.
The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External hex implant | Experimental | External hexagone implant connection |
|
| Internal hex implant | Experimental | Internal implant connection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant insertion | Device | In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites. A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement. Random allocation of implant type per site will be done by the sealed envelope method. Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process. Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of alveolar ridge thickness at 4 months | Peroperative surgical measurements of the alveolar ridge width at implant sites | During procedure and at 4 months |
| Change from baseline of radiographic bone level on CBCT at 1 year post-op | CBCT for buccal bone thickness measurements of the bone crest width at the implant site. | During procedure and at 1 year |
| Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray | Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact | During procedure, at 4 months, at 6 months and 1 year |
| Change from baseline of bone plate thickness at 4 months | Peroperative buccal and lingual residual bone thickness following implant insertion | During procedure and at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion torque | Manual torque insertion are registered at implant placement. | During procedure |
| Change of Clinical parameters from baseline to 1 year post-op | FMBS, FMPS, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nada Naaman, PhD | Saint-Joseph University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Joseph University | Beirut | 1104 2020 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29401469 | Background | Shi JY, Jie-Ni, Zhuang LF, Zhang XM, Fan LF, Lai HC. Peri-implant conditions and marginal bone loss around cemented and screw-retained single implant crowns in posterior regions: A retrospective cohort study with up to 4 years follow-up. PLoS One. 2018 Feb 5;13(2):e0191717. doi: 10.1371/journal.pone.0191717. eCollection 2018. | |
| 24894890 |
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The outcome measurements and patients characteristics might be shared
1 year from date of publication
Following a direct request, for meta-analysis or literature review report.
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|
| During procedure, at 6 months and at 1 year |
| Change of FMBS parameters from baseline to 1 year post-op | Change in full mouth bleeding score | During procedure, at 6 months and at 1 year |
| Change of Keratinized tissue height from Baseline to 4 months | Measured using a 1.0-mm marked periodontal probe | During procedure and at 4 months |
| Histological analysis | Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality | During procedure |
| Change of FMPS parameters from baseline to 1 year post-op | Change in full mouth plaque score | During procedure, at 6 months and at 1 year |
| Liu J, Kerns DG. Mechanisms of guided bone regeneration: a review. Open Dent J. 2014 May 16;8:56-65. doi: 10.2174/1874210601408010056. eCollection 2014. |
| 27224562 | Background | Koller CD, Pereira-Cenci T, Boscato N. Parameters Associated with Marginal Bone Loss around Implant after Prosthetic Loading. Braz Dent J. 2016 May-Jun;27(3):292-7. doi: 10.1590/0103-6440201600874. |
| 9590940 | Background | Wennerberg A, Hallgren C, Johansson C, Danelli S. A histomorphometric evaluation of screw-shaped implants each prepared with two surface roughnesses. Clin Oral Implants Res. 1998 Feb;9(1):11-9. doi: 10.1034/j.1600-0501.1998.090102.x. |
| 23138742 | Background | Rosa MB, Albrektsson T, Francischone CE, Schwartz Filho HO, Wennerberg A. The influence of surface treatment on the implant roughness pattern. J Appl Oral Sci. 2012 Sep-Oct;20(5):550-5. doi: 10.1590/s1678-77572012000500010. |
| 25048469 | Background | Esposito M, Ardebili Y, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2014 Jul 22;(7):CD003815. doi: 10.1002/14651858.CD003815.pub4. |
| 29569767 | Background | Donati M, Ekestubbe A, Lindhe J, Wennstrom JL. Marginal bone loss at implants with different surface characteristics - A 20-year follow-up of a randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):480-487. doi: 10.1111/clr.13145. Epub 2018 Mar 23. |
| 11324207 | Background | Testori T, Wiseman L, Woolfe S, Porter SS. A prospective multicenter clinical study of the Osseotite implant: four-year interim report. Int J Oral Maxillofac Implants. 2001 Mar-Apr;16(2):193-200. |
| 20367092 | Background | Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennstrom JL, Chierico A, Stach RM, Kenealy JN. A prospective, multicenter, randomized-controlled 5-year study of hybrid and fully etched implants for the incidence of peri-implantitis. J Periodontol. 2010 Apr;81(4):493-501. doi: 10.1902/jop.2009.090492. |
| 9558555 | Background | Nevins M, Mellonig JT, Clem DS 3rd, Reiser GM, Buser DA. Implants in regenerated bone: long-term survival. Int J Periodontics Restorative Dent. 1998 Feb;18(1):34-45. |