Connective Tissue Graft and Leucocyte - Platelet Rich Fibrin in Alveolar Ridge Preservation

NCT06663982 | Not Yet Recruiting

• 1 other identifier: 27102024
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of our randomized controlled clinical trial is to evaluate radiographic bone dimensional changes and soft tissue healing and thickness after teeth extraction and the implementation of alveolar ridge preservation (RAP) procedures that will involve the application of L-PRF inside the socket in association with a connective tissue graft (CTG) used as a barrier with the periosteal inhibition technique (PI). The present experimental treatment (test group) will be compared with an active comparator (control group) which will involve the insertion of L-PRF alone inside the socket.

Conditions

Alveolar Socket Preservation

Outcome Measures

Primary Outcomes (1)

• Horizontal Bone Crest

  Horizontal width of the alveolar ridge

  4 months

Study Arms (2)

CTG + L-PRF

EXPERIMENTAL

Procedure: Connective tissue graft + L-PRF

L-PRF

ACTIVE COMPARATOR

Procedure: L-PRF

Interventions

Connective tissue graft + L-PRF PROCEDURE

After administering local anesthesia, an atraumatic extraction will be conducted, preserving the buccal bone and carefully debriding the alveolar socket. Following papilla incisions, an intra-sulcular incision on the vestibular side of the extraction socket will be extended with a #15c scalpel, creating a socket to insert the connective tissue graft (CTG). The CTG will be harvested from the palatal area following a specific incision technique to obtain a graft around 1.5 mm thick, which will be fixed with a mattress suture. Then the socket will be filled with L-PRF plugs. A collagen sponge will cover the extraction socket and L-PRF, secured with a 4-0 cross suture. Sutures will be removed after 15 days.

CTG + L-PRF

L-PRF PROCEDURE

After administering local anesthesia, an atraumatic extraction will be conducted, preserving the buccal bone and carefully debriding the alveolar socket. Then the socket will be filled with L-PRF plugs. A collagen sponge will cover the extraction socket and L-PRF, secured with a 4-0 cross suture. Sutures will be removed after 15 days.

L-PRF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* Age \> 18 years old; * General good health (ASA I-II); * Adequate oral hygiene (Full Mouth Plaque Score ≤ 20%, Full Mouth Bleeding Score ≤ 20%); * Presence of one or more hopeless teeth requiring extraction.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• G. d'Annunzio University: lead

Central Study Contacts

Michele Paolantonio

CONTACT

+39 08713554158; michelepaolantonio@gmail.com

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 Professor

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: December 9, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10