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

October 28, 2024 updated by: Michele Paolantonio, G. d'Annunzio University

Periosteal Inhibition Technique With Connective Tissue Graft and Leucocyte- Platelet Rich Fibrin in Alveolar Ridge Preservation: a Randomized Controlled Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTG + L-PRF
Procedure: Connective tissue graft + L-PRF

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.
Active Comparator: L-PRF
Procedure: L-PRF

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal Bone Crest
Time Frame: 4 months
Horizontal width of the alveolar ridge
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G. d'Annunzio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 9, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

October 27, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 27102024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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