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

Gingival Recession, Generalized Clinical Trial

Official title:

Xenogeneic Collagen Matrix and Connective Tissue Graft Comparison for Multiple Gingival Recessions in Esthetic Areas: A Non-inferiority Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207984
• Other study ID #: 9075852
• Status: Completed
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 1, 2021
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Generalized

Intervention

Procedure:
• Root coverage surgery
Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM

Locations

Country	Name	City	State
Brazil	Raphaella C Michel	Bauru	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Geistlich Pharma AG

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complete root coverage	Assessed in which the gingival margin was at or above the cementoenamel junction (CEJ)	year
Other	Probing Depth (PD)	Distance in millimeters from the gingival margin to the bottom of the gingival sulcus at three points (mesial, center and distal)	year
Other	Clinical attachment level loss (CAL)	Measured in millimeters from the bottom of the periodontal pocket to the cementoenamel junction at three sites per tooth (mesial, center and distal)	year
Other	Soft tissue thickness (STT)	Determined at 2mm apical the gingival margin at the central buccal site with anesthetic needle and endodontic stop and digital pachymeter	year
Primary	Gingival recession depth (GRD)	Distance in millimeters from ECJ to gingival margin at three points (mesial, center and distal); Distance from cemento-enamel junction to gingival margin = 0 mm	one year
Secondary	Keratinized mucosa width	Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width > 5mm	year
Secondary	Dentin hypersensitivity	Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0	year