Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457373
• Other study ID #: (DDA) for socket preservation
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: Horus University
• Contact: Mohamed Habib, B.D.S
• Phone: +2001069505336
• Email: mbasiouny[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry- Horus University in Egypt	Damietta	New-Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Horus University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. Erratum In: Contemp Clin Dent. 2017 Jul-Sep;8(3):509. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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