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Evaluation of Volume Stable Collagen Matrix in RT2 Gingival Recession Compared to Connective Tissue Graft

NCT05568732 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-01-30

No results posted yet for this study

Summary

Gingival recession is the migration of the gingiva to a point apical to the cemento-enamel junction. In order to treat challenging miller class 3 or RT2 recessions, several mucogingival approaches have been proposed. The subepithelial connective tissue graft (CTG) combined with a coronally advanced flap (CAF) has been considered as the "gold standard" for recession coverage around teeth. However, significant resorption of CT graft material has been reported if the graft material is exposed. And that can reduce the possibility of complete root coverage. volume stable collagen matrix - (VCMX ) is a volume stable, fully resorbable, porous, collagen matrix of porcine origin and spongious consistency and is one of the most biocompatible, novel material to be used in this study. VCMX of porcine origin is predominantly made of collagen type I and III and a small portion of elastin. VCMX is able to overcome the volume stability limitation of most commercially available grafts. The surgical technique proposed in a case series using a volume-stable collagen matrix and autogenous subepithelial CTG may be an effective method for periodontal biotype modification through thickening of the entire facial aspect for the treatment of gingival recession. VCMX consists of a single porous layer with interconnected pores (93% volume porosity) and an average pore size of 92 µm. While mechanical stability is achieved by chemical crosslinking, mechanical testing demonstrated preserved elasticity of the material over 14 days. Data have convincingly demonstrated enhanced promigratory and proadhesive properties of three primary cell types human oral fibroblas(hOFs) and human umblical vein endothelial cells(HUVECs), grown on the VCMX. The VCMX was characterized with an efficient adsorption of four recombinant growth factors (TGF-β, PDGF-BB, FGF-2, and GDF-5), naturally present in the blood clot. And in a RCT with Miller's class 1 and 2 it also showed that it provides volume stability and withstands early resorption, while encouraging formation of new soft tissue. Due to its wettability, suture-ability and biological properties, the device has been reported to become well integrated with surrounding soft tissue. No study has been evident on comparing VCMX and SCTG for Miller's class 3/RT2 recession defect. Therefore the purpose of the study is to compare the clinical outcome of VCMX ans SCTG in Miller's class 3/RT2 .

Conditions

  • Gingival Recession

Interventions

PROCEDURE

Root coverage procedure will be done with VCMX

Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with VCMX using minimally invasive access technique.

PROCEDURE

Root coverage procedure will be done with CTG

Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

  • VAISHALI PAGADE, BDS · POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05568732 on ClinicalTrials.gov