A Phase 4 interventional study of Coronally advanced flap (CAF) and Collagen Matrix in Gingival Recession, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 15 is below the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria:
The patients will be included in the study if they fulfill the following inclusion criteria:
Exclusion Criteria: -
The exclusion criteria used will be as follows:
The exclusion criteria for teeth will be:
A new collagen matrix (Mucograft) associated to coronally advanced flap
Procedure: Coronally advanced flap (CAF) · Drug: Collagen Matrix
Subepithelial connective tissue graft associated to coronally advanced flap
Procedure: Coronally advanced flap (CAF) · Procedure: Subepithelial connective tissue graft
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.
Also known as: Subepithelial conjunctive tissue grafts, Coronally advanced flaps, Coronally advanced flaps associated with collagen matrix
A new collagen membrane
Also known as: Mucograft
Connective tissue graft
Also known as: connective tissue graft
Percentage of root coverage (RC)
The primary clinical outcome will be percentage of root coverage (RC) at 12 months
Time frame: 12-months
Reductions in recession depth (RRD)
Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin
Time frame: At the baseline, 3-month, 6-month and 12-months
Complete root coverage of the gingival recessions (CRC)
Time frame: At the baseline, 3-month, 6-month and 12-months
Recession width (RW) at the cemento-enamel junction
Time frame: At the baseline, 3-month, 6-month and 12-months
Relative clinical attachment level (RCAL)
Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus.
Time frame: At the baseline, 3-month, 6-month and 12-months
Probing depth (PD)
Calculated as RCAL- PD;
Time frame: At the baseline, 3-month, 6-month and 12-months
keratinized tissue width (KT)
From the free gingival margin to the mucogingival junction.
Time frame: At the baseline, 3-month, 6-month and 12-months
Gain in thickness of gingival tissue (GT)
With an injection needle and a silicon marker, 2mm below the gingival margin.
Time frame: At the baseline, 3-month, 6-month and 12-months
Subject esthetic satisfaction by participants
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.
Time frame: 1, 3, 6 months and after 12 months
Subjective symptoms of pain and discomfort by participants
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.
Time frame: At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.
Esthetic questionnaire by experienced periodontist
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.
Time frame: 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo