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NCT Number: NCT06663982

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

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.

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Key information

Conditions

Alveolar Socket Preservation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Horizontal Bone Crest

    Time frame: 4 months

    Horizontal width of the alveolar ridge

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Paolantonio

CONTACT

[email protected]

+39 08713554158

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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