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

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.

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Periodontal surgery with CAF+tSCTG; Procedure: Periodontal surgery with CAF+L-PRF

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pescara, Italy, 65121
    • Michele Paolantonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAF+tSCTG; 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; Coronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area.
Active Comparator: CAF+L-PRF; 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; Coronally advanced flap and L-PRF membranes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival thickness	Gingival tissue thickness 2 mm apical to the recession	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinized tissue height	Distance between gingival margin and Mucogingival Junction	12 months
Gingival recession	Distance from cementoenamel junction and gingival margin	12 months
Complete root coverage	Percentage of experimental sites that achieved complete root surface coverage.	12 months
Clinical attachment level	Distance between cementoenamel junction(CEJ) and depth of the pocket	12 months
Pocket depth	Distance between gingival margin and bottom of the pocket	12 months

Collaborators and Investigators

• Sponsor: G. d'Annunzio University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): October 29, 2023
• Study Completion (Actual): October 29, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Root coverage; Periodontal plastic surgery
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 13032023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No