Comparison of Coronally Advanced Root Coverage Procedure With Collagen Matrix and Connective Tissue Graft

NCT04195737 | Completed

• 1 other identifier: 02_D012_100209
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a coronally advanced flap with ossix volumaxTM collagen matrix and connective tissue graft in the treatment of multiple adjacent gingival recession defects. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Conditions

Gingival Recession

Keywords

Gingival Recession Coverage

Outcome Measures

Primary Outcomes (3)

• gingival recession depth

  measured as the distance from the CEJ to the gingival margin.

  6 months

• Complete root coverage

  root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction

  6 months

• Mean root coverage

  (Baseline recession depth - 6 month recession depth/Baseline recession depth)\*100

  6 months

Secondary Outcomes (9)

• pocket Probing depth

  6 months

• Gingival Recession width

  6 months

• Clinical attachment level

  6 months

• Gingival biotype thickness

  6 months

• Apico-coronal width of keratinized tissue

  6 months

Study Arms (2)

Root coverage with ossix volumax collagen matrix

EXPERIMENTAL

Evaluation of root coverage achieved by collagen matrix in conjunction with coronally advanced flap in patients with multiple gingival recession.

Procedure: Ossix volumax collagen matrix

Root coverage with connective tissue graft

ACTIVE COMPARATOR

Evaluation of root coverage achieved by connective tissue graft in conjunction with coronally advanced flap in patients with multiple gingival recession

Procedure: Connective Tissue Graft

Interventions

Ossix volumax collagen matrix PROCEDURE

Under LA horizontal incision is made.Split-full-split thickness flap is elevated.The remaining soft tissue of the anatomic interdental papillae deepithelialized.Coronal advancement of the flap obtained and closed using sling suture.

Root coverage with ossix volumax collagen matrix

Connective Tissue Graft PROCEDURE

Under LA parallel incisions is made 1-2 mm first molar to canine.Graft incision 1 mm coronal to the horizontal flap incision.Through this incision designed graft thickness is obtained.The graft obtained between the two horizontal incisions has a 1 mm coronal strip that require depithelisation with a knife and closed using interrupted suture.

Root coverage with connective tissue graft

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age greater than or equal to18 years.
• Multiple adjacent Miller's class I and class II gingival recession sites.
• Patients with healthy or treated periodontal conditions.
• Patients with esthetic concerns.
• Absence of uncontrolled medical conditions.
• Full mouth plaque score \</= 10% (O'Leary 1972)
• Full mouth bleeding score \<10% (Ainamo and Bay 1975)

You may not qualify if:

• Gingival biotype less than 0.8 mm.
• Pregnant or lactating females.
• Tobacco smoking.
• Untreated periodontal conditions.
• Use of systemic antibiotics in the past 3 months.
• Patients treated with any medication known to cause gingival hyperplasia

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Prabhuji MLV

  Krishnadevarya Dental College

  STUDY DIRECTOR

Study Design

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

Model Details: Two groups were made one test and control. The test group will be treated with coronally advanced flap with ossix volumax™ collagen matrix and control group will be treated with coronally advanced flap with Sub epitheial Connective Tissue Graft.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: December 12, 2019
• Primary Completion: July 17, 2021
• Study Completion: August 6, 2021
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

IN (1)