Lateral Ridge Augmentation Around Implants

December 31, 2019 updated by: Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Prabhuji MLV, MDS

Study Locations

    • Karnataka
      • Bengaluru, Karnataka, India, 562157
        • Recruiting
        • Krishnadevaraya college of dental sciences and hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cooperative patients willing to participate in the study belonging to 20-50 years of age group
  2. Patients indicated for implant placement
  3. 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.
  4. Full mouth plaque score (FMPS) < 20 %, Full mouth bleeding score (FMBS) < 20 %.11
  5. Ability to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations.
  6. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form.

    -

Exclusion Criteria:

  1. Smokers
  2. Probing depth >4 mm
  3. General contraindications for dental and/or surgical treatment
  4. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 yrs
  5. Pregnancy or breast feeding
  6. Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
  7. History of any allergic diseases -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resorbable collagen membrane and bone graft
Subjects will receive bovine derived bone graft and resorbable collagen membrane for augmentation.

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)

Other Names:
  • Cerabone®
  • Ossix Plus®
Experimental: Ribose cross-linked collagen matrix
Subjects will receive ribose cross linked collagen matrix for augmentation

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).

Other Names:
  • Ossix Volumax®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Prabhuji MLV, MDS, Krishnadevaraya college of dental sciences
  • Study Director: Karthikeyan Bangalore Varadhan, MDS, Krishnadevaraya college of dental sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

January 20, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02_D012_101329

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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