Skip to main content
OpenTrials
Completed

NCT Number: NCT03207984

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raphaella C Michel

Bauru, São Paulo, 17012-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Root coverage surgery

Procedure

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

Primary outcomes

  1. Gingival recession depth (GRD)

    Time frame: one year

    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

Secondary outcomes

  1. Keratinized mucosa width

    Time frame: year

    Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width > 5mm

  2. Dentin hypersensitivity

    Time frame: year

    Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0

Other outcomes

  1. Complete root coverage

    Time frame: year

    Assessed in which the gingival margin was at or above the cementoenamel junction (CEJ)

  2. Probing Depth (PD)

    Time frame: year

    Distance in millimeters from the gingival margin to the bottom of the gingival sulcus at three points (mesial, center and distal)

  3. Clinical attachment level loss (CAL)

    Time frame: year

    Measured in millimeters from the bottom of the periodontal pocket to the cementoenamel junction at three sites per tooth (mesial, center and distal)

  4. Soft tissue thickness (STT)

    Time frame: year

    Determined at 2mm apical the gingival margin at the central buccal site with anesthetic needle and endodontic stop and digital pachymeter

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Geistlich Pharma AG

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jul 5, 2017
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.