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

NCT05568732 | Unknown DMC

• 1 other identifier: vaishali pagade perio 22/29
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Root coverage percentage

  Percentage of root coverage will be calculated by using pre and post operative recession depth

  9 months

Study Arms (2)

Test group

EXPERIMENTAL

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 VCMX

Control group

ACTIVE COMPARATOR

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.

Procedure: Root coverage procedure will be done with CTG

Interventions

Root coverage procedure will be done with VCMX PROCEDURE

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.

Test group

Root coverage procedure will be done with CTG PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients with Millers class3\[4\] or RT2\[6\] isolated recession defects in labial mandibular anterior teeth region.
• \. Systemically healthy individuals.
• \. Absence of clinical tooth mobility.
• \. Age 18-45 years old.
• \. A full mouth plaque index \< 20%
• \. Patient showing adequate compliance and willing to participate in the study.

You may not qualify if:

• Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
• Previous surgical attempt to correct gingival recession.
• Crowding of affected teeth.
• Patients with active periodontal disease.
• Smokers and tobacco users.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute Of Dental Science

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• VAISHALI PAGADE, BDS

  POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SHIKHA TEWARI, MDS

CONTACT

9416514600; drshikhatewari@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 15, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)