Comparison of Root Coverage of Gingival Recessions

NCT02980055 | Unknown Phase 2

• 1 other identifier: UFRN-3
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up.

Conditions

Gingival Recession

Keywords

connective tissue graft; transplantation; collagen; autologous; gingiva

Outcome Measures

Primary Outcomes (6)

• gingival recession

  baseline

• gingival recession

  three months

• gingival recession

  six months

• gingival recession

  twelve months

• gingival recession

  eighteen months

• gingival recession

  twenty-four months

Secondary Outcomes (1)

• Width of keratinized mucosa

  baseline and three, six, twelve, eighteen and twenty-four months

Study Arms (2)

Test: collagen matrix

EXPERIMENTAL

Root coverage using collagen matrix

Procedure: collagen matrix

Control: connective tissue graft

ACTIVE COMPARATOR

Root coverage using connective tissue graft

Procedure: connective tissue graft

Interventions

collagen matrix PROCEDURE

Surgical procedure for root coverage using collagen matrix

Also known as: xenogeneic collagen matrix

Test: collagen matrix

connective tissue graft PROCEDURE

Surgical procedure for root coverage using connective tissue graft

Also known as: autologous

Control: connective tissue graft

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines;
• Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003);
• The teeth with gingival recession should not be restored in their cervical portion;
• Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm;
• Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.

You may not qualify if:

• Orthodontic appliances;
• Fixed or removable prostheses involving the premolar teeth with gingival recession;
• Being a smoker;
• Pregnancy or lactation;
• Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Karyna M Menezes, Master

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno CV Gurgel, Doctor

CONTACT

+558432154107; bcgurgel@yahoo.com.br

Samuel B Borges, student

CONTACT

sborges1990@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invastigator

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 2, 2016
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: December 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share