NCT03675334

Brief Summary

Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft. The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

September 10, 2018

Last Update Submit

April 11, 2026

Conditions

Gingival Recession

Keywords

clinical trialroot coveragebiomaterialscollagen matrixcoronally advanced flap

Outcome Measures

Primary Outcomes (1)

  • Root coverage after 6 months

    Root coverage is measured by the difference between the gingival recession height at 6 months and baseline

    6 months

Secondary Outcomes (1)

  • Keratinized tissue gain after 6 months

    6months

Study Arms (2)

Test Group

ACTIVE COMPARATOR

Active comparator: gingival recession the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions

Procedure: Root coverage with collagen matrix graftOther: Basic periodontal treatment

Control Group

PLACEBO COMPARATOR

the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.

Procedure: Root coverage with subepithelial connective tissue graftOther: Basic periodontal treatment

Interventions

Root coverage with collagen matrix graftPROCEDURE

at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.

Test Group
Basic periodontal treatmentOTHER

profilaxis, coronary polishing and scaling and root planning

Control GroupTest Group
Root coverage with subepithelial connective tissue graftPROCEDURE

at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.

Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • CEJ without significant damage;
  • localized bilateral RT1 gingival recession ≥3 mm in the same arch

You may not qualify if:

  • previous periodontal surgical treatment on the involved sites;
  • smokers
  • pregnants or lactating
  • compromised systemic health and contraindications for periodontal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry of Ribeirao Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (1)

  • Suzuki KT, de Jesus Hernandez Martinez C, Suemi MI, Palioto DB, Messora MR, de Souza SLS, Novaes AB Jr, Chaves Furlaneto FA, Taba M Jr. Root coverage using coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft: a randomized controlled clinical trial. Clin Oral Investig. 2020 Nov;24(11):4077-4087. doi: 10.1007/s00784-020-03280-x. Epub 2020 May 7.

    PMID: 32382931DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The clinical parameters were screened by one single examiner that was not aware of the procedures
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Split-mouth clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, Ms, DDs. Chairman of Periodontolgy

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 18, 2018

Study Start

April 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)