Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions

NCT ID: NCT03207984

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-08
• Study Completion Date: 2021-12-01

Brief Summary

Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).

Detailed Description

Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental treatment, especially when it comes to gingival recession. However, there is a lack of evidence in the literature explaining the most appropriate type of treatment for multiple recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective tissue graft (SCTG) is considered the gold standard because it presents greater predictability for root coverage. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of CM are very promising, both for root coverage as well as for the gain of keratinized mucosa. The present study will consist of a double-blind parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors, Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3, 6, and 12 months after the surgical procedure.

Conditions

Gingival Recession, Generalized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control SCTG

Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas

Group Type: ACTIVE_COMPARATOR

Root coverage surgery

Intervention Type: PROCEDURE

Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM

Test CM

Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas

Group Type: EXPERIMENTAL

Root coverage surgery

Intervention Type: PROCEDURE

Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM

Interventions

Root coverage surgery

Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine);
• Miller class I and II gingival recession areas
• Non-abrasive, erosive, or carious root surfaces
• Unrotated, non-extruded, and non-movable teeth
• Systemically healthy patients without contraindication to periodontal surgical procedures

Exclusion Criteria

• Smokers
• Pregnant women and infants
• Patients with a history of periodontal disease or recurrent abscess formation
• Patients previously submitted to surgical procedures for root coverage
• Patients taking anti-convulsant drugs
• Antihypertensives, contraceptives or immunosuppressors
• Patients with low oral hygiene (plaque and bleeding index over 20%)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geistlich Pharma AG

INDUSTRY

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Raphaella Coelho Michel

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raphaella C Michel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo, Bauru School of Dentistry

Locations

Raphaella C Michel

Bauru, São Paulo, Brazil

Countries

Brazil

References

McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.

Reference Type: BACKGROUND

PMID: 20350159 (View on PubMed)

Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.

Reference Type: BACKGROUND

PMID: 21721988 (View on PubMed)

Other Identifiers

9075852

Identifier Type: -

Identifier Source: org_study_id