Treatment of Multiple Gingival Recessions

Phase 4

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Coronally advanced flap (CAF); Procedure: Subepithelial connective tissue graft; Drug: Collagen Matrix

• Registration Number: NCT02818855
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-08-20
• Study Start: 2014-03
• Primary Completion: 2015-10
• Study Completion: 2016-04
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• The patients will be included in the study if they fulfill the following inclusion criteria:

  1. a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
  2. areas of Miller's Class I or II GR;
  3. teeth without root abrasions or caries.

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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:

1. noncarious cervical lesions (erosion, abfraction etc.)
2. any type of previous cervical restoration
3. extrusion
4. giroversion
5. mobility
6. a prominent root surface.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subepithelial connective tissue graft plus CAF	Subepithelial connective tissue graft	Subepithelial connective tissue graft associated to coronally advanced flap
Subepithelial connective tissue graft plus CAF	Coronally advanced flap (CAF)	Subepithelial connective tissue graft associated to coronally advanced flap
Collagen Matrix plus coronally advanced flap (CAF)	Coronally advanced flap (CAF)	A new collagen matrix (Mucograft) associated to coronally advanced flap
Collagen Matrix plus coronally advanced flap (CAF)	Collagen Matrix	A new collagen matrix (Mucograft) associated to coronally advanced flap

Primary Outcome Measures

Name	Time	Method
Percentage of root coverage (RC)	12-months	The primary clinical outcome will be percentage of root coverage (RC) at 12 months

Secondary Outcome Measures

Name	Time	Method
Reductions in recession depth (RRD)	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
Complete root coverage of the gingival recessions (CRC)	At the baseline, 3-month, 6-month and 12-months
Recession width (RW) at the cemento-enamel junction	At the baseline, 3-month, 6-month and 12-months
Relative clinical attachment level (RCAL)	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.
Probing depth (PD)	At the baseline, 3-month, 6-month and 12-months	Calculated as RCAL- PD;
keratinized tissue width (KT)	At the baseline, 3-month, 6-month and 12-months	From the free gingival margin to the mucogingival junction.
Gain in thickness of gingival tissue (GT)	At the baseline, 3-month, 6-month and 12-months	With an injection needle and a silicon marker, 2mm below the gingival margin.

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Brazil