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Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage

G

G. d'Annunzio University

Status

Completed

Conditions

Gingival Recession

Treatments

Procedure: Periodontal surgery with CAF+tSCTG
Procedure: Periodontal surgery with CAF+L-PRF

Study type

Interventional

Funder types

Other

Identifiers

NCT05783258
13032023

Details and patient eligibility

About

The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.

A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Presence of a class RT1 recession;
  • age > 18 years;
  • systemic health conditions that do not affect the periodontium;
  • Non smoker;
  • FMPS and FMBS values < 20% before the surgical procedure;
  • absence of implants or subgingival restorations in the sites to be treated;
  • presence of adequate tissue distal to the last maxillary molar.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

CAF+tSCTG
Experimental group
Description:
15 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed at the level of the maxillary tuberosity. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.
Treatment:
Procedure: Periodontal surgery with CAF+tSCTG
CAF+L-PRF
Active Comparator group
Description:
15 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm,2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession. Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa. The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of bone.A partial thickness dissection will be performed in the apical portion of the flap to obtain complete passivation.The L-PRF membranes will be realized centrifuged venous blood collected in two 10-ml sterile tubes at 3000 rpm for 10 minutes and squeezing the fibrin clot. L-PRF membranes will be superimposed to crete a double layer of about 2 mm thickness.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.
Treatment:
Procedure: Periodontal surgery with CAF+L-PRF

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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