Clinical trial NCT06457373: Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
Official title: The Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation After Surgical Extraction of Impacted Mandibular Third Molar
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Keywords: Socket preservation
Impacted mandibular third molar
Alveolar ridge Augmentation
Lead sponsor: Horus University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 sockets will be grafted with Demineralized Dentin Allograft (DDA) and 20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measuring and comparing the height of bone between the two groups
timeFrame: Immediately post-operative, 3months post-operative, 6months post-operative
measure: Measuring and comparing the width of bone between the two groups
timeFrame: Immediately post-operative, 3months post-operative, 6months post-operative
Secondary outcomes:
measure: Assess and comparing the mouth opening of both groups
timeFrame: One day post-operative, one week post-operative
measure: Assess and comparing the swelling of both groups
timeFrame: One day post-operative, one week post-operative
measure: Assess and comparing the pain of both groups
timeFrame: One day post-operative, one week post-operative
measure: Assess and comparing the soft tissue parameters (bleeding on probing and color of the gingiva) of both groups
timeFrame: One day post-operative, one week post-operative
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Faculty of Dentistry- Horus University in Egypt
state: New-Damietta
Study officials:
affiliation: Faculty of Dentistry- Horus University in Egypt
name: Mohamed Habib, B.D.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry- Horus University in Egypt
name: Ahmed Khalil
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry- Horus University in Egypt
name: Eman Abdelsalam
role: STUDY_DIRECTOR
References:
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.
citation: 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.