N/A
N=60
Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession
Gingival Recession
Bottom Line
View on ClinicalTrials.gov: NCT03712852 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Gingival Thickness — 1.97; 1.95; 1.39 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRF+CAF treated patients (Procedure); SCTG+ CAF treated patients (Procedure); CAF treated patients (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- G. d'Annunzio University
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gingival Thickness |
1.97; 1.95; 1.39 | — |
| SECONDARY Gingival Recession |
3.28; 3.70; 3.05 | — |
| SECONDARY Keratinized Tissue |
0.08; 2.00; -0.15 | — |
| SECONDARY Pocket Depth |
0.20; -0.10; 0.45 | — |
| SECONDARY Clinical Attachment Level |
3.38; 3.60; 3.40 | — |
| SECONDARY Patient Reported Outcomes (PROMs) |
3.37; 3.58; 4.73 | — |
| SECONDARY Aesthetic |
2.56; 2.50; 2.74 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- a full-mouth plaque score (FMPS)* and a full-mouth bleeding score (FMBS)* lower than 20%, at the time of surgery
- to have at least 20 teeth at leat 1 maxillary tooth exhibiting a single Miller second class of gingival recession .
Exclusion Criteria
- no systemic diseases;
- no coagulation disorders;
- no medications affecting periodontal status in the previous 6 months;
- no pregnancy or lactation;
- no presence of cervical carious lesions,;
- no periodontal surgery on the experimental sites
- no smoking habits
- no inadequate endodontic treatment at the site of surgery
- no presence of cervical carious lesions
Data sourced from ClinicalTrials.gov (NCT03712852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.