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

NCT05783258 | Completed

• 1 other identifier: 13032023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession

Keywords

Root coverage; Periodontal plastic surgery

Outcome Measures

Primary Outcomes (1)

• Gingival thickness

  Gingival tissue thickness 2 mm apical to the recession

  12 months

Secondary Outcomes (5)

• Keratinized tissue height

  12 months

• Gingival recession

  12 months

• Complete root coverage

  12 months

• Clinical attachment level

  12 months

• Pocket depth

  12 months

Study Arms (2)

CAF+tSCTG

EXPERIMENTAL

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.

Procedure: Periodontal surgery with CAF+tSCTG

CAF+L-PRF

ACTIVE COMPARATOR

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.

Procedure: Periodontal surgery with CAF+L-PRF

Interventions

Periodontal surgery with CAF+tSCTG PROCEDURE

Coronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area.

CAF+tSCTG

Periodontal surgery with CAF+L-PRF PROCEDURE

Coronally advanced flap and L-PRF membranes

CAF+L-PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Michele Paolantonio

Pescara, 65121, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time professor

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: June 13, 2022
• Primary Completion: October 29, 2023
• Study Completion: October 29, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)