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 | Completed Phase 3 DMC

• 1 other identifier: P-ME-23-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bone Loss; Bone Remodeling Disorder; Bone Resorption

Keywords

socket preservation; alveolar ridge defect; Dentin graft; Demineralized freeze dried allograft

Outcome Measures

Primary Outcomes (2)

• change in radiographic Socket dimensions from base line to 6 months

  CBCT measuring socket dimensions

  6 months following the end of treatment

• change in bone density from base line to 6 months

  CBCT measuring bone density within the socket

  6 months following the end of treatment

Secondary Outcomes (2)

• new bone formation

  after six months at the time of implant placement

• implant stability

  after six months at the time of implant placement

Study Arms (2)

demineralized freeze dried allograft

ACTIVE COMPARATOR

demineralized freeze dried allograft with collagen sponge

Combination Product: Demineralized freeze dried allograft with collagen sponge

autogenous dentin graft

ACTIVE COMPARATOR

Autogenous dentin graft with collagen sponge

Combination Product: autogenous dentin graft with collagen sponge

Interventions

Demineralized freeze dried allograft with collagen sponge COMBINATION_PRODUCT

Demineralized freeze dried allograft,filling 2/3 of the socket covered with collagen sponge ,six months, one time

Also known as: DFDBA

demineralized freeze dried allograft

autogenous dentin graft with collagen sponge COMBINATION_PRODUCT

autogenous mineralized dentin graft, filling 2/3 of the socket covered with collagen sponge , six months, one time

Also known as: ADG

autogenous dentin graft

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead
• Beni-Suef University: collaborator

Study Sites (1)

AL Azhar university for girls

Cairo, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant

Model Details: test group :socket preservation by dentin graft covered with collagen sponge control group :socket preservation by demineralized freeze dried allograft covered by collagen sponge

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 3, 2025
• Study Start: September 15, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

EG (1)