Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation

NCT06457373 | Not Yet Recruiting DMC

• 1 other identifier: (DDA) for socket preservation
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate and compare clinically and radiographically the effectiveness of Demineralized Dentin Allograft (DDA) versus Demineralized Dentin Autograft (Auto-DD) for preservation of alveolar ridge dimensions after surgical extraction of the impacted mandibular third molar.

Conditions

Alveolar Bone Loss

Keywords

Socket preservation; Impacted mandibular third molar; Alveolar ridge Augmentation

Outcome Measures

Primary Outcomes (2)

• Measuring and comparing the height of bone between the two groups

  We will measure the height of the alveolar ridge clinically by using ridge mapping caliper (special caliper forceps used for measuring ridge dimensions) and radiographically on the cone-beam computed tomography (CBCT) and comparing the results of the study group (20 sockets) with the control group (the other 20sockets), to assess the effectiveness of Demineralized Dentin Allograft for ridge preservation

  Immediately post-operative, 3months post-operative, 6months post-operative

• Measuring and comparing the width of bone between the two groups

  We will measure the width of the alveolar ridge clinically by using ridge mapping caliper (special caliper forceps used for measuring ridge dimensions) and radiographically on the cone-beam computed tomography (CBCT) and comparing the results of the study group (20 sockets) with the control group (the other 20sockets), to assess the effectiveness of Demineralized Dentin Allograft for ridge preservation

  Immediately post-operative, 3months post-operative, 6months post-operative

Secondary Outcomes (4)

• Assess and comparing the mouth opening of both groups

  One day post-operative, one week post-operative

• Assess and comparing the swelling of both groups

  One day post-operative, one week post-operative

• Assess and comparing the pain of both groups

  One day post-operative, one week post-operative

• Assess and comparing the soft tissue parameters (bleeding on probing and color of the gingiva) of both groups

  One day post-operative, one week post-operative

Study Arms (2)

Group A

EXPERIMENTAL

20 sockets will be grafted with Demineralized Dentin Allograft (DDA)

Procedure: Demineralized Dentin Allograft

Group B

ACTIVE COMPARATOR

20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD)

Procedure: Demineralized Dentin Autograft

Interventions

Demineralized Dentin Autograft PROCEDURE

20 sockets are randomly allocated to receive the Demineralized Dentin Autograft (split-mouth study)

Also known as: Auto-DD

Group B

Demineralized Dentin Allograft PROCEDURE

20 sockets are randomly allocated to receive the Demineralized Dentin Allograft (split-mouth study)

Also known as: DDA

Group A

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 25 to 35 years old.
• Patients scored as (ASA I).
• No adverse habits such as smoking, tobacco chewing, alcohol.
• Patients having bilaterally impacted mandibular third molar with similar degree of difficulty according to (Kim JY, et al).
• The recipient alveolar sockets are free of any pre-existing periapical pathology, based on x-ray.
• Alveolar sockets with a depth of 5 mm or more, using periodontal probe for assessment.
• Patients sign a consent for all procedures.

You may not qualify if:

• \) Pregnant or lactating patients. 2) Relevant systemic diseases. 3) Patients with history of chemotherapy or radiotherapy.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Faculty of Dentistry- Horus University in Egypt

Damietta, New-Damietta, 34518, Egypt

Location

Related Publications (2)

• Joshi CP, D'Lima CB, Samat UC, Karde PA, Patil AG, Dani NH. Comparative Alveolar Ridge Preservation Using Allogenous Tooth Graft versus Free-dried Bone Allograft: A Randomized, Controlled, Prospective, Clinical Pilot Study. Contemp Clin Dent. 2017 Apr-Jun;8(2):211-217. doi: 10.4103/ccd.ccd_147_17.

  PMID: 28839405 BACKGROUND

• Grover V, Kapoor A, Malhotra R, Sachdeva S. Bone allografts: a review of safety and efficacy. Indian J Dent Res. 2011 May-Jun;22(3):496. doi: 10.4103/0970-9290.87084.

  PMID: 22048602 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

bis(p-chlorophenyl)acetic acid

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mohamed Habib, B.D.S

  Faculty of Dentistry- Horus University in Egypt

  PRINCIPAL INVESTIGATOR

• Ahmed Khalil

  Faculty of Dentistry- Horus University in Egypt

  STUDY DIRECTOR

• Eman Abdelsalam

  Faculty of Dentistry- Horus University in Egypt

  STUDY DIRECTOR

Central Study Contacts

Mohamed Habib, B.D.S

CONTACT

+2001069505336; mbasiouny@horus.edu.eg

Ahmed Khalil, PHD

CONTACT

+2001005062045; akhalil@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and maxillofacial surgery clinical demonstrator

Model Details: 20 sockets will be grafted with Demineralized Dentin Allograft (DDA) and 20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD)

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 13, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)