Clinical Evaluation of Gingival Biotype Changes Using a Coronally Advanced Flap (CAF) in Combination with Leucocyte and Platelet- Rich Fibrin (L-PRF) Membranes of Different Thickness for the Treatment of RT1 Gingival Recession: a Randomized Controlled Clinical Trial.

NCT06701799 | Not Yet Recruiting DMC

• 1 other identifier: 211124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Gingival thickness plays a key role not only in the etiology but also in the treatment of gingival recessions. 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. The treatment gold standard is the CAF associated with connective tissue graft. 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. In this scenario, The Platelet rich in fibrin and leucocyte (L-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. L- 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 study will be to evaluate if the different thickness of platelet- rich fibrin (L-PRF) membranes in association with a Coronally Advanced Flap (CAF), for the treatment of RT1 gingival recessions, may influence the Complete Root Coverage (CRC).

Conditions

Mucogingival Defects; Recession, Gingival; Gingival Recession, Mucogingival Surgery; L-PRF

Keywords

Coronally Advanced Flap; L-PRF; Platelet concentrate; Gingival Recession; Gingival Biotype

Outcome Measures

Primary Outcomes (1)

• Complete root coverage

  Percentage of experimental sites that achieved complete root surface coverage.

  6 months

Secondary Outcomes (8)

• Keratinized tissue width

  6 months

• Clinical attachment level

  6 months

• Gingival Recession

  6 months

• Gingival thickness

  6 months

• Pocket depth

  6 months

Study Arms (2)

CAF+ L-PRF 2 mm

EXPERIMENTAL

Coronally Advanced Flap combined with in combination with a membrane 2 mm in thickness of L-PRF for the Treatment of RT1 Gingival Recession.

Procedure: CAF+ L-PRF 2 mm

CAF+ L-PRF 1 mm

EXPERIMENTAL

Coronally Advanced Flap combined with in combination with a membrane 1 mm in thickness of L-PRF for the Treatment of RT1 Gingival Recession.

Procedure: CAF+ L-PRF 1 mm

Interventions

CAF+ L-PRF 1 mm PROCEDURE

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 L-PRF membrane 1 mm in thickness, will be positioned at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones, using a Non-Resorbable 5.0 Polyamide Suture.

CAF+ L-PRF 1 mm

CAF+ L-PRF 2 mm PROCEDURE

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 L-PRF membrane 2 mm in thickness, will be positioned at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones, using a Non-Resorbable 5.0 Polyamide Suture.

CAF+ L-PRF 2 mm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation)
• Never smokers/former smokers \>=10years
• Full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS) lower than 15%
• No periodontal surgery on the experimental sites
• \>= 20 teeth without mobility
• No presence of cervical carious lesions or periapical lesions at experimental sites
• At least one RT1 buccal gingival recession

You may not qualify if:

• Systemic diseases
• Coagulation disorders
• Medications affecting periodontal status in the previous 6 months
• Pregnancy or lactation
• Smokers

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Department of Innovative Technologies in Medicine and Dentistry, Chieti

Chieti, CH, 66100, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Michele Paolantonio, MD, DDS

CONTACT

3395204073; michelepaolantonio@gmail.com

Study Design

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

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start: November 30, 2024
• Primary Completion: May 31, 2025
• Study Completion: November 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

IT (1)