Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study

Conditions
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Dental Implantation, Bone Remodeling

Intervention / Treatment
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* Device: Implant insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age: between 20 and 65 No systematic contraindication for implant surgery No more than 10 cigarettes/day Previous horizontal bone augmentation 6 months prior to implant placement Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%) Exclusion Criteria: Smokers more than 10 cigarettes/day Pregnant/lactating women Alcoholics/drug addicts Uncontrolled diabetics, immunocompromised, blood hemostasis problems Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing Patients not willing to sign the consent form History of radiotherapy in the head and neck region in the last 5 years Active periodontitis on the remaining teeth

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: External hex implant<br>External hexagone implant connection | Device: Implant insertion<br>* 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.<br>* Other names: Radiological bone level;|
| Experimental: Internal hex implant<br>Internal implant connection | Device: Implant insertion<br>* 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.<br>* Other names: Radiological bone level;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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, | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alveolar ridge augmentation, Dental implants, Marginal bone remodeling