Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The present CONSORT-based randomized clinical trial is to assess the adjunctive benefit of a xenogenic collagen matrix in combination with a coronal advanced flap with respect to a coronal advanced flap alone in the treatment of multiple gingival recession defects in adult population.
This is a single-centre, superiority, double blind clinical trial, with balanced randomisation and parallel two groups design. The 2 groups will be:
The objective is therefore to assess the adjunctive benefit of a xenogenic collagen matrix in combination with a coronal advanced flap.
The primary endpoint is the mean recession reduction after 6 and 12 months post treatment.
The secondary endpoints are: Percentage of complete root coverage after 6 and 12 month; Thickness of soft tissue over the root after 6 and 12 month; Recession width after 6 and 12 month; KT width; Patients satisfaction.
The following Inclusion Criteria have to be satisfied: patient (male or female) must be 18 years or older, not pregnant, and candidate for buccal root coverage procedure in the upper jaw; recession defects have to be AAA or ABA (according to Rotundo et al classification), with at least 2 adjacent RC with ≥ 2 mm RC depth and root abrasion depth less than 1 mm; Patient shows sufficient plaque control (FMPS ≤ 20%) and acceptable bleeding score(FMBS ≤ 20%); Teeth intended to treat are in the region 1 - 5; patient has to be able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures; patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.
Randomisation: Computer-generated blocked for each centre, with allocation concealment by opaque sequentially numbered sealed envelopes.
Blinding: Patients and outcome assessor blind to group assignment.
Sample size: Based on a formula for cluster design to detect a difference between treatments of 1 mm in recession reduction (standard deviation of 0.93 mm - Woodyard et al. 2004) with a two-side 5% significance level, a power of 90%, a mean number of treated teeth per patient of 2.92, an intraclass correlation coefficient of 0.35, a sample size of 24 patients per treatment will be necessary.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAF+XCM | Experimental | An envelope split-full-split thickness flap without vertical incisions will be carried out in the gingival recession area. Afterwards, a xenogenic collagen matrix (XCM) will be applied to all teeth with recession defect. The XCM will be cut into the right dimensions, measured with the probe, and its measurements recorded; then it will be placed from the CEJ to the bone crest on the recipient bed using single sutures, 7/0 PGA sutures. The matrix will be rehydrated with blood, in order to reconstitute and maintain the maximal thickness possible. The flap will be closed slightly coronal to the CEJ with a sling suture using resorbable PGA 6/0 sutures and avoiding any compression of the matrix. |
|
| CAF alone | Active Comparator | An envelope split-full-split thickness flap without vertical incisions will be carried out. The root surfaces will be mechanically treated with the use of curettes. A sharp dissection into the vestibular lining mucosa will be then carried out to eliminate muscle tension. Sling sutures will be performed to accomplish a precise adaptation of the buccal flap on the exposed root surfaces and to stabilize every single surgical papilla over the de-epithelialized anatomic papillae. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAF+XCM | Procedure | After flap elevation according to the Coronally Advanced Flap procedure for multiple recession defects, a Xenogeneic Collagen Matrix was applied and then covered by the flap. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Recession Reduction | The distance between CEJ and the free gingival margin (Rec depth) will be measured at baseline, 3, 6 and 12 months. The mean change will be then calculated. | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2012 | Feb 8, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
single-centre, superiority, double blind clinical trial, with balanced randomisation and parallel two groups design according to CONSORT statement
Not provided
Not provided
Not provided
| CAF alone | Procedure | Coronally Advanced Flap procedure alone was performed to treat multiple recession defects |
|
| D055093 |
| Periodontal Atrophy |