Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation

The Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation After Surgical Extraction of Impacted Mandibular Third Molar

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Demineralized Dentin Allograft; Procedure: Demineralized Dentin Autograft

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Habib, B.D.S; Phone Number: +2001069505336; Email: mbasiouny@horus.edu.eg
• Study Contact Backup: Name: Ahmed Khalil, PHD; Phone Number: +2001005062045; Email: akhalil@horus.edu.eg

Study Locations

• Egypt
  • New-Damietta
    • Damietta, New-Damietta, Egypt, 34518
      • Faculty of Dentistry- Horus University in Egypt
      • Contact: Mohamed Habib, B.D.S; Phone Number: +2001069505336; Email: mbasiouny@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 20 sockets will be grafted with Demineralized Dentin Allograft (DDA)	Procedure: Demineralized Dentin Allograft; 20 sockets are randomly allocated to receive the Demineralized Dentin Allograft (split-mouth study); Other Names: DDA
Active Comparator: Group B; 20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD)	Procedure: Demineralized Dentin Autograft; 20 sockets are randomly allocated to receive the Demineralized Dentin Autograft (split-mouth study); Other Names: Auto-DD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess and comparing the mouth opening of both groups	Assess the mouth opening of the patient using a millimeter ruler (by measuring the distance between maxillary incisal edge and mandibular incisal edge) and comparing the results of both groups	One day post-operative, one week post-operative
Assess and comparing the swelling of both groups	Swelling levels after surgery will be measured using anatomic landmarks (Tragus-Labial commissure and Tragus-Pogonion), the distances between the landmarks used for the evaluation methods will be measured before the operation. All measurements will be done using millimeter ruler, while the patient will be seated.	One day post-operative, one week post-operative
Assess and comparing the pain of both groups	we will use the Visual Analogue Scale (VAS) for pain measurement	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	The bleeding on probing will be assessed by using periodontal probe and this will be done around mandibular first and second molars	One day post-operative, one week post-operative

Collaborators and Investigators

• Sponsor: Horus University
• Investigators: Principal Investigator: Mohamed Habib, B.D.S, Faculty of Dentistry- Horus University in Egypt; Study Director: Ahmed Khalil, Faculty of Dentistry- Horus University in Egypt; Study Director: Eman Abdelsalam, Faculty of Dentistry- Horus University in Egypt

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Socket preservation; Impacted mandibular third molar; Alveolar ridge Augmentation
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss; bis(p-chlorophenyl)acetic acid
• Other Study ID Numbers: (DDA) for socket preservation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No