Autogenous Tooth Bone Graft Versus Allogeneic Bone Graft Around Dental Implant in Aesthetic Zone
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).
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt, 3111
- Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Autogenous tooth bone graft group
Twelve patients receiving immediate implant placement with autogenous fresh partially demineralized dentin graft.
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Immediate dental implant placement with grafting of the jumping gap using allogeneic bone graft (DFDBA).
|
|
Active Comparator: Allogeneic bone graft group (control group)
Patients receiving immediate dental implant placement with allogeneic bone graft (DFDBA) for grafting of the jumping gap.
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after atraumatic extraction immediate implant will be inserted with allogenic bone graft
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marginal bone loss
Time Frame: 6 months
|
6 months
|
|
|
labial bone thickness
Time Frame: 6 months
|
measuring thickness of labial bone labial to the implant
|
6 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone density around dental implant
Time Frame: 6 months
|
bone density will be assessed using CBCT buccal to the implant fixtures 6 months after implant installation
|
6 months
|
|
implant secondary stability
Time Frame: 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
|
6 months
|
|
implant success
Time Frame: 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
|
6 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: diab abdelgaied diab, master, faculty of dentistry Tanta university
- Principal Investigator: Rafic ramadan bedir, professor, faculty of dentistry Tanta university
- Principal Investigator: Ibrahim mohammed nowair, professor, faculty of dentistry Tanta university
- Principal Investigator: Mona samy sheta, lecturer, faculty of dentistry Tanta university
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- diab123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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