Socket Preservation Using Dentin Graft Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability AUTOGENOUS TOOTH GRAFT WITH COLLAGEN SPONGE ON DENTAL IMPLANT STABILITY

NCT06853392 — Phase 3, Completed, 16 participants, Faculty of Dental Medicine for Girls

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Evaluation of Socket Preservation Using Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability

Registry	NCT06853392
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	16 (Actual)
Sponsor	Faculty of Dental Medicine for Girls (Other gov); collaborators: Beni-Suef University
Conditions	Bone Loss, Bone Remodeling Disorder, Bone Resorption
Interventions	Demineralized freeze dried allograft with collagen sponge, autogenous dentin graft with collagen sponge (Combination product)
Dates	start 2023-09-15, primary completion 2024-04-01, completion 2024-06-01, first posted 2025-03-03, last updated 2025-03-03
Locations	1 site in Egypt

-Summary

The present study was performed to evaluate socket preservation using collagen sponge with autogenous dentin graft versus collagen sponge with de-mineralised freez-dried bone graft on dental implant stability

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+Detailed description

in our study we made socket preservation using two different grafts in two groups.

before grafting we took CBCT

we used autogenous dentin graft covered by collagen sponge in one group and demineralized freeze - dried allograft covered with collagen sponge in the other group.

after 6 months we Took another CBCT to assist the dimensional changes and bone density in the alveolar socket after grafting We inserted the implant and during insertion we took a core biopsy with trephine bur with external diameter 3 mm for histological analysis.

After implant insertion we assisted the stability using RFA.

+Arms and interventions

Arm	Type	Interventions	Description
demineralized freeze dried allograft	Active comparator	Combination Product: Demineralized freeze dried allograft with collagen sponge	demineralized freeze dried allograft with collagen sponge
autogenous dentin graft	Active comparator	Combination Product: autogenous dentin graft with collagen sponge	Autogenous dentin graft with collagen sponge

Demineralized freeze dried allograft with collagen sponge (Combination product), also known as DFDBA: Demineralized freeze dried allograft,filling 2/3 of the socket covered with collagen sponge ,six months, one time
autogenous dentin graft with collagen sponge (Combination product), also known as ADG: autogenous mineralized dentin graft, filling 2/3 of the socket covered with collagen sponge , six months, one time

+Outcome measures

Primary outcomes

change in radiographic Socket dimensions from base line to 6 months [6 months following the end of treatment]: CBCT measuring socket dimensions
change in bone density from base line to 6 months [6 months following the end of treatment]: CBCT measuring bone density within the socket

Secondary outcomes

new bone formation [after six months at the time of implant placement]: Histological analysis for new bone formation by masson trichrome
implant stability [after six months at the time of implant placement]: measuring primary Implant Stability by resonance frequency analysis

+Eligibility

Sex: Female, ages: 25 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* Patients are free from any systemic diseases.
* Patients with good oral hygiene.
* Age range from 25-50 years.
* Adequate inter arch space .

Exclusion Criteria:

* Medications that may affect bone turnover, and bone metabolic diseases.
* Smoker patients and alcoholics.
* Patients with parafunctional habits.
* Patients with active acute infection related to tooth of interest.
* Patients with a lack of compliance, and serious mental or psychological problems.
* Pregnant females.

+Locations (1)

Facility	City	Country	Status
AL Azhar university for girls	Cairo	Egypt