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N/A N=60 Randomized Triple-blind Treatment

Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession

Gingival Recession

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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