Gingival Recession
Conditions
Keywords
Root coverage, Gingival recession, Plastic surgery, Connective tissue graft, Mucograft
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.
Interventions
PROCEDURECoronally advanced flap (CAF)
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.
DRUGCollagen Matrix
A new collagen membrane
Connective tissue graft
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
- The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of root coverage (RC) | 12-months | The primary clinical outcome will be percentage of root coverage (RC) at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recession width (RW) at the cemento-enamel junction | At the baseline, 3-month, 6-month and 12-months | — |
| 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. |
| 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 | — |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Esthetic questionnaire by experienced periodontist | 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. |
| Subject esthetic satisfaction by participants | 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. |
| Subjective symptoms of pain and discomfort by participants | 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. |
Countries
Brazil
Outcome results
None listed