- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06773104
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
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt, 3111
- Faculty of Dentistry
-
-
Participation 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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Autogenous tooth bone graft group
Twelve patients receiving immediate implant placement with autogenous fresh partially demineralized dentin graft.
|
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.
|
after atraumatic extraction immediate implant will be inserted with allogenic bone graft
|
What is the study measuring?
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
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
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thin Labial Plate of Bone Pre-extraction
-
Cairo UniversityCompletedImmediate Implants | Esthetic Zone | Labial Bone Dimensional Changes | Without Labial Bone Grafting | With Labial Grafting | Thin Labial Plate of Bone Pre-extractionEgypt
-
Tanta UniversityEnrolling by invitationThin Labial Plate of Bone Pre-extraction | Immediate Dental Implants | Hopeless Tooth in Esthetic ZoneEgypt
-
Mansoura UniversityNot yet recruitingNon-restorable Posterior Teeth | Thin Buccal Bone Plate | Buccal Bone FenestraionEgypt
-
University Hospital, GrenobleNot yet recruitingOsteosynthesis of Fibula Fractures With a Locked Thin PlateFrance
-
Cairo UniversityUnknown
-
Nuhayra Ashour MuhammedCompletedthe Augmentation of Labial Defective Wall in Fresh Extraction SocketEgypt
-
Faculty of Dental Medicine for GirlsCompletedAmount of Labial Bone Thickness | Amount of Root ResorptionEgypt
-
University of Alabama at BirminghamRecruitingExtraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted TeethUnited States
-
Rui FigueiredoMTS Europe GmbH (sponsor)WithdrawnBone Resorption | Loss of Teeth Due to ExtractionSpain
-
Implantology InstituteUnknownBone Resorption | Alveolar Bone Loss | Loss of Teeth Due to ExtractionPortugal
Clinical Trials on immediate implant with allogenic bone graft
-
Cairo UniversityNot yet recruitingImmediate Implants Connective Tissue Graft
-
Tanta UniversityCompletedPosterior Mandible With Deficient Ridge HeightEgypt
-
Cairo UniversityActive, not recruitingImmediate Dental ImplantsEgypt
-
Cairo UniversityCompletedAlveolar Socket PreservationEgypt
-
Cairo UniversityCompletedImmediate Implant With Bone GraftEgypt
-
Cairo UniversityUnknownImmediate Temporization and Soft Tissue Augmentation Around Delayed ImplantsEgypt
-
Mansoura UniversityCompletedImmediate ImplantsEgypt
-
Universitat Internacional de CatalunyaInstitut Straumann AGNot yet recruitingConnective Tissue Graft | Connective Tissue Graft Harvesting | Soft Tissue Management in Subcrestal Dental Implants | Immediate Dental Implant Placement
-
University of Medicine and Pharmacy at Ho Chi Minh...RecruitingAlveolar Bone Loss | Esthetic Zone Implant RehabilitationVietnam
-
Cairo UniversityCompletedImmediate Implants | Esthetic Zone | Labial Bone Dimensional Changes | Without Labial Bone Grafting | With Labial Grafting | Thin Labial Plate of Bone Pre-extractionEgypt