NCT04197128

Lateral Ridge Augmentation Around Implants

Status unknown NA Last updated 3 January 2020

What this trial tests

NA trial testing Resorbable Collagen membrane with bone graft for augmentation in Alveolar Bone Resorption in 28 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
30 December 2020

20 January 2021

Quick facts

Lead sponsor	Krishnadevaraya College of Dental Sciences & Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	28
Start date	1 August 2019
Primary completion	30 December 2020
Estimated completion	20 January 2021
Sites	1 location across India

Drugs / interventions tested

• Resorbable Collagen membrane with bone graft for augmentation
• Ribose cross linked collagen matrix for augmentation

Conditions studied

• Alveolar Bone Resorption — all drugs for Alveolar Bone Resorption →

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Who can join

Adults 20 to 50, any sex, with Alveolar Bone Resorption. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.