Post Extraction Changes After Alveolar Socket Preservation Using Autogenous Dentin Graft (ADG) Combined With Either Albumin Platelet-rich Fibrin (ALB-PRF) or Standard Platelet-rich Fibrin (PRF).

NCT06757218 | Recruiting DMC

• 1 other identifier: KFSIRB200-471
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study focuses on the impact of tooth loss on alveolar bone, which shrinks significantly within the first three months. To prevent this, strategies like alveolar ridge preservation are used. Autogenous dentin, taken from the patient, supports healing and bone regrowth. Platelet-rich fibrin (PRF), made from the patient's blood, enhances healing and bone density by releasing growth factors. A new technique combining L-PRF with albumin creates a stable healing membrane that provides a steady release of growth factors. Overall, these methods improve recovery after tooth extractions and prepare sites for future dental work.

Conditions

Alveolar Socket Preservation

Keywords

Autogenous Dentin Graft; Albumin Platelet Rich Fibrin; Platelet Rich Fibrin

Outcome Measures

Primary Outcomes (3)

• Alveolar ridge width (buccolingual).

  Will be assessed via Cone-Beam Computed Tomography (CBCT) that Provides a radiographic assessment of the buccolingual width by measuring the distance between buccal and lingual bone walls.

  at baseline immediately after extraction and after six months

• Alveolar ridge height (apicocronal)

  Will be assessed via Cone-Beam Computed Tomography (CBCT) that Provides a radiographic assessment of the apicocronal height by measuring the ridge height from the top of the alveolar ridge to the upper border of the alveolar canal.

  at baseline immediately after extraction and after six months

• Bone density

  Will be assessed via Cone-Beam Computed Tomography (CBCT) The measurement helps in assessing the quality of bone directly through Hounsfield units (HU) (between D1 and D5; D1: \> 1250 HU, D2: 850 to 1250 HU, D3: 350 to 850 HU, D4: 150 to 350 HU, D5: \< 150 HU).

  at baseline immediately after extraction and after six months

Secondary Outcomes (3)

• Pain scores

  at 24 hours, 3 days, 7 days and 14 days postoperative

• Patient satisfaction

  at 24 hours, 3 days, 7 days,14 days postoperative and after six months

• Keratinized tissue width

  at baseline before extraction and after six months

Study Arms (3)

empty socket

OTHER

Other: empty socket

Autogenous Dentin Graft with Platelet Rich Fibrin

ACTIVE COMPARATOR

Autogenous Dentin Graft with Albumin Platelet Rich Fibrin

EXPERIMENTAL

Procedure: Autogenous Dentin Graft with Albumin Platelet Rich Fibrin

Interventions

empty socket OTHER

Patients will be left socket empty without any graft materials for spontaneous healing process after tooth extraction

empty socket

Autogenous Dentin Graft with Platelet Rich Fibrin PROCEDURE

Patients will be inserting autogenous dentin graft and platelet rich fibrin in the socket after extraction.

Autogenous Dentin Graft with Albumin Platelet Rich Fibrin PROCEDURE

Patients will be inserting autogenous dentin graft and Albumin Platelet Rich Fibrin in the socket after extraction.

Autogenous Dentin Graft with Albumin Platelet Rich Fibrin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Medically free patients.
• Adult patients above 18 Years to 60 Years.
• Non-restorable tooth indicated for extraction.
• Posterior mandibular teeth.
• Inactive infection related to the tooth.
• Cooperative patients.

You may not qualify if:

• Presence of any systemic disease that could influence the outcome of the therapy.
• Presence of any risk factor (smoker, pregnant and lactating patients).
• Patients with bone diseases.
• Patients with poor oral hygiene.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kaferelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 6860404, Egypt

RECRUITING

Study Officials

• Enas Ahmed Elgendy, PhD

  Kaferelsheikh University

  STUDY DIRECTOR

Central Study Contacts

MUATH ATIF HASSAN

CONTACT

+201507571780; muath_01pg@den.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding is achievable for the biostatistician also . However, Care Provider cannot be blinded due to the fundamentally different surgical procedures in the three groups. It is not possible to blind the participants since those in the test groups will undergo a specific intervention that involves venous blood withdrawal for the preparation of PRF and ALB-PRF. Concerning the blinding of participants, we will implement partial blinding, which will apply exclusively to the test groups (group 1 and 2) involved in a specific intervention that requires venous blood collection for the creation of PRF and ALB-PRF.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Model Details: A randomized controlled clinical study, Double blinded (patients and biostatistician) with allocation ratio 1:1:1 using 3 - arm parallel groups (2 experimental and control).

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)