Lateral Ridge Augmentation Around Implants

Study Overview
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Brief Summary
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The rehabilitation of dentoalveolar defects and tooth loss has seen remarkable advancements over time. Extraction of tooth leads to reduction in physiologic dimension of bone and it is imperative to evaluate the site before implant placement. To overcome the loss of volume and to avoid complications, procedures to restore the resorbed alveolar bones prior to or during implant placement are usually performed. Lateral bone augmentation procedures with guided bone regeneration (GBR) are well documented in the literature with predictable results. It generally involves bone substitute xenograft and bioresorbable membrane combined with implant placement in single stage procedure or separately in two- stage procedure. As the search for better and improved materials continues, a porcine derived ribose cross-linked volumising collagen matrix (VCMX) based on GLYMATRIX® technology has been introduced which showed benefits over the conventional membranes in terms of simplified procedure, degradation, membrane exposure and healing. The collagen scaffold has been reportedly used as a core material for guided bone regeneration, when there is sufficient bone to place an implant but a horizontal defect is present in the crestal ridge. As part of augmentation VCMX is designed to expand and ossify during healing. The advantage of the material is that when placed in one or two layers, it may eliminate the use of bone substitute or connective tissue graft thus simplifying the augmentation procedure. In addition, adding a bone substitute is a valid option based on indication. In the quest of better material and simplified procedures, few authors have performed case studies based on application of VCMX for guided bone regeneration around dental implants and has shown promising results. However, there are no controlled clinical trials on application of VCMX for lateral ridge augmentation. Thus, the present study aims to assess the efficiency of VCMX compared to resorbable collagen membrane (RCM) and bone graft (BG) for lateral ridge augmentation around implants through a well designed, controlled clinical trial.

Detailed Description
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Source of data Patient visiting the Outpatient Section of the Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital for replacement of lost teeth will be screened and randomly recruited for the study as per inclusion and exclusion criteria. The eligible subjects will be informed of the nature and benefits of the participation of the study and a written signed consent will be obtained. Method of collection of data Sample Size The study would be a prospective, randomized controlled clinical trial. A sample size of 28 subjects with equal number of males and females who are eligible as per the inclusion criteria, belonging to 20 - 50 years of age group would be considered for the study. Sample size is calculated using online software (OpenEpi) Open Source Epidemiologic Statistics for Public Health, Version 3.01. Estimation is done considering a similar previous study to acquire 80% power and 5% type 1 error in power calculation.

Official Title
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Comparative Evaluation of Novel Ribose Cross Linked Volumising Collagen Matrix v/s Ribose Cross Linked Resorbable Collagen Membrane and Bone Graft for Lateral Ridge Augmentation Around Implants: A Randomised Controlled Clinical Trial

Conditions
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Alveolar Bone Resorption

Intervention / Treatment
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* Device: Resorbable Collagen membrane with bone graft for augmentation
* Device: Ribose cross linked collagen matrix for augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cooperative patients willing to participate in the study belonging to 20-50 years of age group Patients indicated for implant placement Based on SAC classification (Straight forward, Advanced, Complex), if the bone defect has at least two walls intact and implant placement is possible within the confines of ridge.10 In the present study, subjects belonging to Advanced category i.e., where simultaneous guided bone regeneration and implant placement is possible it would be considered. Full mouth plaque score (FMPS) < 20 %, Full mouth bleeding score (FMBS) < 20 %.11 Ability to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form. - Exclusion Criteria: Smokers Probing depth >4 mm General contraindications for dental and/or surgical treatment History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 yrs Pregnancy or breast feeding Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs) History of any allergic diseases -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: The subjects are randomly divided into 2 groups i.e., Control and Test group each consisting of equal number of participants who are age and sex matched.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resorbable collagen membrane and bone graft<br>Subjects will receive bovine derived bone graft and resorbable collagen membrane for augmentation. | Device: Resorbable Collagen membrane with bone graft for augmentation<br>* Local anaesthesia Lignocaine and Adrenaline 1:80000 Injection (Lignox® 2% A, Indoco remedies Ltd, Mumbai) will be administered and midcrestal incison will be made and full thickness flap would be raised buccally. To obtain tension free adaptation of flap margins, the buccal flap advancement will be done using periosteal releasing incision. Implant osteotomies will be performed with sequential drilling and with standardised drills. All the subjects will receive the same implant system. (Norris medical ltd. Hatasia street, Nesher, Israel) For augmentation of deficient ridge, bovine bone graft will be place with overlying resorbable collagen membrane. Stabilisation would be achieved with internal resorbable horizontal mattress suture. The tension free flap margins will be adapted around the healing abutment with simple interrupted Vicryl 4.0, 3/8, reverse cutting resorbable sutures (Ethicon, Hamburg, Germany)<br>* Other names: Ossix Plus®;|
| Experimental: Ribose cross-linked collagen matrix<br>Subjects will receive ribose cross linked collagen matrix for augmentation | Device: Ribose cross linked collagen matrix for augmentation<br>* Local anaesthesia Lignocaine and Adrenaline 1:80000 Injection (Lignox® 2% A, Indoco remedies Ltd, Mumbai) will be administered and midcrestal incison will be made and full thickness flap would be raised buccally. To obtain tension free adaptation of flap margins, the buccal flap advancement will be done using periosteal releasing incision. Implant osteotomies will be performed with sequential drilling and with standardised drills. All the subjects will receive the same implant system. (Norris medical ltd. Hatasia street, Nesher, Israel) For augmentation of deficient ridge, ribose cross linked collagen matrix will be cut and adapted to the buccal wall and ridge around the buccal aspect of healing abutment. Stabilisation would be achieved with internal resorbable horizontal mattress suture. The tension free flap margins will be adapted around the healing abutment with simple interrupted 4.0, 3/8, reverse cutting resorbable sutures (Ethicon, Hamburg, Germany).<br>* Other names: Ossix Volumax®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ridge width | Ridge width would be measured pre-operatively and post-operatively using Cone beam computed tomography. | 6 months | 
| Gingival thickness | Clinical and radiographic assessment would be performed | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient- reported outcome 1 | Post operative pain and discomfort would be measured using Visual analogue scale | 6 months | 
| Patient reported outcome 2 | Number of analgesics consumed would be assessed during post- operative period | 6 months | 
| Safety evaluation 1 | Number of subjects with adverse healing | 6 months | 
| Safety evaluation 2 | Number of subjects who had membrane exposure | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral augmentation, Ribose cross-linked collagen, Dental Implant