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Completed

NCT Number: NCT02818855

Treatment of Multiple Gingival Recessions

Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of São Paulo

São Paulo, 05508-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The patients will be included in the study if they fulfill the following inclusion criteria:
  • a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
  • areas of Miller's Class I or II GR;
  • teeth without root abrasions or caries.

Exclusion criteria

-

The exclusion criteria used will be as follows:

  • patients allergic to collagen
  • a history of smoking (within the previous 6 months)
  • pregnancy or lactation
  • a history of destructive periodontal disease or the formation of recurrent abscesses
  • root caries at the site of recession
  • previous surgical root coverage procedures
  • systemic healing disorders (for example, acquired immunodeficiency syndrome [AIDS], diabetes mellitus or risk factors evaluated by a medical doctor)
  • periodontal disease, or poor plaque control (full mouth plaque index > 20%).

The exclusion criteria for teeth will be:

  • noncarious cervical lesions (erosion, abfraction etc.)
  • any type of previous cervical restoration
  • extrusion
  • giroversion
  • mobility
  • a prominent root surface.

Treatment and study plan

Coronally advanced flap (CAF)

Procedure

The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap.

The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.

Other names: Subepithelial conjunctive tissue grafts, Coronally advanced flaps, Coronally advanced flaps associated with collagen matrix

Collagen Matrix

Drug

A new collagen membrane

Other names: Mucograft

Subepithelial connective tissue graft

Procedure

Connective tissue graft

Other names: connective tissue graft

Primary outcomes

  1. Percentage of root coverage (RC)

    Time frame: 12-months

    The primary clinical outcome will be percentage of root coverage (RC) at 12 months

Secondary outcomes

  1. Reductions in recession depth (RRD)

    Time frame: At the baseline, 3-month, 6-month and 12-months

    Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin

  2. Complete root coverage of the gingival recessions (CRC)

    Time frame: At the baseline, 3-month, 6-month and 12-months

  3. Recession width (RW) at the cemento-enamel junction

    Time frame: At the baseline, 3-month, 6-month and 12-months

  4. Relative clinical attachment level (RCAL)

    Time frame: At the baseline, 3-month, 6-month and 12-months

    Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus.

  5. Probing depth (PD)

    Time frame: At the baseline, 3-month, 6-month and 12-months

    Calculated as RCAL- PD;

  6. keratinized tissue width (KT)

    Time frame: At the baseline, 3-month, 6-month and 12-months

    From the free gingival margin to the mucogingival junction.

  7. Gain in thickness of gingival tissue (GT)

    Time frame: At the baseline, 3-month, 6-month and 12-months

    With an injection needle and a silicon marker, 2mm below the gingival margin.

Other outcomes

  1. Subject esthetic satisfaction by participants

    Time frame: 1, 3, 6 months and after 12 months

    The participants will be invited to reply to a questionnaire on subject esthetic satisfaction with the surgical results (from dissatisfied to very satisfied) on a scale of 1-5, as well as after 1, 3, 6 months and after 12 months.

  2. Subjective symptoms of pain and discomfort by participants

    Time frame: At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.

    Subjective symptoms of pain and discomfort (without pain and with a great deal of pain) will be evaluated with 10 cm (0-10) visual analog scales (VAS) at 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.

  3. Esthetic questionnaire by experienced periodontist

    Time frame: 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery

    One experienced periodontist will be invited to observe the initial photographs and those of the clinical results obtained during the entire healing process and asked to respond to an esthetic questionnaire (from dissatisfied to very satisfied) on a scale of 1 to 5 points after 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months.12 All this examinations also will be performed in the clinic.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial

Acronym: 3DMUCO

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 30, 2016
Registry last updated
Feb 5, 2018

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.

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