Autogenous Tooth Bone Graft Versus Allogeneic Bone Graft Around Dental Implant in Aesthetic Zone

Not Applicable

• Conditions: Immediate Dental Implants; Thin Labial Plate of Bone Pre-extraction; Hopeless Tooth in Esthetic Zone

• Registration Number: NCT06773104
• Lead Sponsor: Tanta University

Brief Summary

24 patienta with non restorable anterior teeth underwent extraction with immediate implant installation using bone grafts either autogenous tooth bone graft or allogenic bone graft Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement with autogenous tooth bone graft.

• Allogeneic bone graft group (control group): 12 patients will have immediate implant placement with allogeneic bone graft (demineralized freeze dried bone allograft - cortico cancellous).

Detailed Description

24 patienta with non restorable anterior teeth underwent extraction with immediate implant installation randomized to two groups Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement with autogenous tooth bone graft.

• Allogeneic bone graft group (control group): 12 patients will have immediate implant placement with allogeneic bone graft (demineralized freeze dried bone allograft - cortico cancellous).

preparation of autogenous tooth bone graft Any restorations, caries, cementum, periodontal ligament and pulp tissue will be removed .The tooth will be grinded using dental bone mill and bone crusher Tooth particles will be sieved to particles size 300 to 1200 microns. The sorted particles will be immersed in 70 % ethanol and 5% Peracetic acid\* in a sterile container for 10 minutes to remove any soft tissue remnants, bacteria and smear layer (defatting and sterilization).

Tooth particles will be demineralized using 2% HNO3for 20 minutes to expose the dentine organic matrix.

The bacteria-free particulate dentin will be washed with phosphate buffered saline‡ twice for 5 minutes to restore the PH balance to 7.4. In the same setting, surgical procedure after atraumatic extraction immediate implant willbe inserted according to dimensions taken from CBCT and jumbing gap will be filled with bone graft according to randomization

Study Timeline

• Study Start: 2024-03-25
• Study First Submitted: 2024-12-30
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-12
• Last Update Submitted: 2025-01-12
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-05-12
• Study Completion: 2025-06-16

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients with non restorable maxillary anterior teeth need to be extracted.

• Thin labial plate of bone of the tooth to be extracted.
• Patients age above 20years old.
• Good oral hygiene.
• No signs of acute infection or inflammation

Exclusion Criteria

• Prior radiation therapy.
• Soft and hard tissue pathology at the operation site.
• Any relevant systemic disease or medication that might compromise bone healing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
labial bone thickness	6 months	measuring thickness of labial bone labial to the implant
marginal bone loss	6 months

Secondary Outcome Measures

Name	Time	Method
bone density around dental implant	6 months	bone density will be assessed using CBCT buccal to the implant fixtures 6 months after implant installation
implant secondary stability	6 months	Implant stability will be assessed at the time of implant insertion and 6 months after the operation. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequencyresponse analyzer (Osstell Mentor Device) with the average of 2measurements performed with the probe in 2 perpendiculardirections
implant success	6 months	when the following clinical features arise: emerging of the fistula, the particle of the bone graft material flow out from the fistula or mucosal dehiscence, and the chronic inflammation ragarded as failure

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Tanta, Egypt