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Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession
NA trial testing PRF+CAF treated patients in Gingival Recession in 60 participants. Completed in 30 July 2019.
| Lead sponsor | G. d'Annunzio University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 20 October 2018 |
| Primary completion | 30 July 2019 |
| Estimated completion | 30 July 2019 |
| Sites | 1 location across Italy |
G. d'Annunzio University
Adults 18 to 60, any sex, with Gingival Recession. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
the change from baseline measured as the thickness of keratinized tissue recorded at 1 mm from the gingival margin
| Group | Value | 95% CI |
|---|---|---|
| PRF+CAF Treated Patients | 1.97 | ± 0.55 |
| SCTG+ CAF Treated Patients | 1.95 | ± 0.28 |
| CAF Treated Patients | 1.39 | ± 0.46 |
the change from baseline measured as the distance between the cemento enamel junction and the gingival margin
| Group | Value | 95% CI |
|---|---|---|
| PRF+CAF Treated Patients | 3.28 | ± 0.59 |
| SCTG+ CAF Treated Patients | 3.70 | ± 0.73 |
| CAF Treated Patients | 3.05 | ± 1.10 |
the change from baseline measured as the distance of the mid-buccal site of the gingival margin to the mucogingival junction
| Group | Value | 95% CI |
|---|---|---|
| PRF+CAF Treated Patients | 0.08 | ± 0.25 |
| SCTG+ CAF Treated Patients | 2.00 | ± 0.97 |
| CAF Treated Patients | -0.15 | ± 0.67 |
the change from baseline measured as the distance between the bottom of the pocket and the gingival margin
| Group | Value | 95% CI |
|---|---|---|
| PRF+CAF Treated Patients | 0.20 | ± 0.34 |
| SCTG+ CAF Treated Patients | -0.10 | ± 0.64 |
| CAF Treated Patients | 0.45 | ± 0.51 |
the change from baseline measured as the distance between the bottom of the pocket and the CEJ
| Group | Value | 95% CI |
|---|---|---|
| PRF+CAF Treated Patients | 3.38 | ± 0.89 |
| SCTG+ CAF Treated Patients | 3.60 | ± 0.60 |
| CAF Treated Patients | 3.40 | ± 0.89 |
A visual analogical scale (VAS) will be used to assess the patient morbidity after treatment. The scale has 10 numerical values, from 1(better outcome) to 10 (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| PRF+CAF Treated Patients | 3.37 | ± 0.326 |
| SCTG+ CAF Treated Patients | 3.58 | ± 0.322 |
| CAF Treated Patients | 4.73 | ± 0.343 |
Aesthetic outcome will be recorded using the root coverage esthetic score (RES) introduced by Cairo et al. in 2009. This score assess five domains: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Zero, 3, or 6 points will be used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point will be used for each of the other variables.The value assigned for root coverage will be 60% of the total score, whereas 40% will be assigned to the other four variables. 3 points will be given for
| Group | Value | 95% CI |
|---|---|---|
| PRF+CAF Treated Patients | 2.56 | ± 0.222 |
| SCTG+ CAF Treated Patients | 2.50 | ± 0.230 |
| CAF Treated Patients | 2.74 | ± 0.240 |
Gingival thickness plays a key role not only in the etiology but also in the treatment of gingival recessions. a thin marginal tissue lining the hard periodontal tissues seems to be one of the main risk factor for the onset of gingival recession ; more recently, authors reported that as the gingival thickness decreases, the gingival recession severity increases . When gingival inflammation occurs, if the tissue is thin the consequent destruction can quickly produce a gingival recession (GR) . When treating a gingival recession, the clinician should aim not only to completely cover the exposed root surface but also to prevent a future recession recurrence Currently, CAF associated with graft is considered as the gold standard for exposed root coverage; this technique has demonstrated high rates in gingival recession reduction and positive predictability in obtaining complete root coverage . However, some disadvantages about this surgical approach can be easily highlighted: patients experience more discomfort, longer chair-time it's necessary and a second wound area is created . On the other hand, CAF procedure alone does not require a second surgical site, with better post-operative course, also reducing the surgical time. However, long term-studies report lower probability of complete root coverage when using the CAF technique without a simultaneous increase of the gingival thickness as compared to CAF+graft treatment. In this scenario, The Platelet rich fibrin (PRF) could be a valuable alternative treatment of gingival defects. It's a platelet concentrate, obtained by a fast and simple procedure that does not require anticoagulant and bovine thrombin . It can also be categorized as a live tissue thanks to platelets, leukocytes, growth factors and stem cells trapped in a polymerized fibrin mesh. PRF is used in various fields of regenerative medicine; It promotes stabilization and revascularization of the flaps, contributes to soft tissue wound healing and reduces post-operative discomfort. The purpose of this clinical study will be to determine if the combination of platelet rich fibrine membrane with a modified coronally advanced flap (MCAF) improved the gingival biotype compared to CAF + graft or CAF alone.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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