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

Gingival Recession Clinical Trial

Official title:

Comparative Evaluation of the Coronally Advanced Flap (CAF) Using a Connective Tissue Graft From the Tuberosity (tCTG) or L-PRF Membranes: a Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05783258
• Other study ID #: 13032023
• Status: Completed
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: October 29, 2023

Study information

• Verified date: November 2023
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 29, 2023
• Est. primary completion date: October 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Periodontal surgery with CAF+tSCTG
Coronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area.
• Periodontal surgery with CAF+L-PRF
Coronally advanced flap and L-PRF membranes

Locations

Country	Name	City	State
Italy	Michele Paolantonio	Pescara

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival thickness	Gingival tissue thickness 2 mm apical to the recession	12 months
Secondary	Keratinized tissue height	Distance between gingival margin and Mucogingival Junction	12 months
Secondary	Gingival recession	Distance from cementoenamel junction and gingival margin	12 months
Secondary	Complete root coverage	Percentage of experimental sites that achieved complete root surface coverage.	12 months
Secondary	Clinical attachment level	Distance between cementoenamel junction(CEJ) and depth of the pocket	12 months
Secondary	Pocket depth	Distance between gingival margin and bottom of the pocket	12 months