Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix

NCT03619096 | Withdrawn DMC

• 1 other identifier: CAAE:65396417000005419
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use has the advantage of avoiding possible pre and postoperative complications , as well as overcome the limitations presented by autograft . The different surgical techniques used for root coverage seek predictability and success . For this, besides the type of incision placements flap and graft are the most important because the healing benefits and outcome . The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..

Conditions

Gingival Recession; Xenograft Model; Gingival Recession, Generalized

Keywords

Gingival recession; porcine collagen matrix; multiple gingival recessions; tunnel technique

Outcome Measures

Primary Outcomes (1)

• Change in gingival recession height (mm)

  Gingival recession height will be measured at baseline, 6 months, and 12 months. The primary outcome will be the change in gingival recession height from baseline to 12 months.

  baseline, 6, and 12 months

Secondary Outcomes (1)

• Keratinized tissue width and thickness (mm)

  baseline, 6, and 12 months

Study Arms (2)

Test Group (tunnel technique)

ACTIVE COMPARATOR

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique

Procedure: tunnel technique for Root coverage with Porcine collagen Matrix

Control Group (extended flap technique)

PLACEBO COMPARATOR

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique

Procedure: extended fla technique for Root coverage with Porcine collagen Matrix

Interventions

tunnel technique for Root coverage with Porcine collagen Matrix PROCEDURE

Tunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix

Also known as: mucograft matrix

Test Group (tunnel technique)

extended fla technique for Root coverage with Porcine collagen Matrix PROCEDURE

Extended flap technique for root coverage for multiple gingival recessions, using porcine collagen matrix

Also known as: mucograft matrix

Control Group (extended flap technique)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height

You may not qualify if:

• diabetics
• pregnant women
• chronic use of medication
• periodontitis
• smokers

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Marilia Bianchini Lemos Reis

Ribeirão Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Arthur Belem Novaes JR

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcomes Assessor are masked about the surgical technique that was performed. The surgical technique ir randomized in accordance with the arch side of each patient, so the investigator will open a envelope just before starting the incisions to know which technique will be performed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher of Periodontia- Department of Buco Maxillofacial Surgery and Traumatology and Periodontics

Model Details: Split Mouth clinical trial, comparing two different techniques. One side, the tunnel technique will be performed and on the other side, extended flap will be performed. Both surgical techniques will use Porcine Collagen Matrix.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: August 7, 2018
• Study Start: March 6, 2017
• Primary Completion: June 6, 2018
• Study Completion: July 6, 2019
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

BR (1)