- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394634
Efficiency of Self Extracted Tooth Graft in Extraction Socket : A Clinical and Radiographic Study
Evaluating the Efficacy of Autogenous Tooth Graft (ATG) Material in Socket Preservation: A Clinical and Radiographic Study.
This is the clinical trial. The goal of this clinical trial is to test whether self extracted tooth graft (autogenous tooth graft ) able to preserved the extraction socket effectively. Our aim is to answer is there any difference in dimensional changes in extraction socket in clinically and radiographically Researchers will compare autogenous tooth graft with self-healing extraction socket in radiographic and clinical measurement.
Participant will be randomly allocated into 2 groups ( Test or controlled group) Test group will be autogenous tooth grafting post extraction. After removed any caries, calculus and any gilling material, the extracted tooth will be grind with grinder and processed using BONMAKER machine. (which the bone graft is washed with hydrogen peroxide, hydrogen chloride and alcohol isopropyl) and controlled group will be self healing group. Both group will withdraw 20cc blood for PRF ( Plasma rich fibrin) membrane and place into the socket and secured with suture. They will be reviewed post extraction 1 week ( to ensure there is no infection ) , 2 week ( for suture removal ) , 1 months ( For clinical measurement) , 3 months (For clinical and radiographic measurement) and 6 months (For radiographic measurement).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Jenjarum, Selangor, Malaysia, 42610
- Faculty of Dentistrty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age> or equal to 18 years old
- Presence of adjacent teeth to the extraction site
- Healthy ,or well controlled systemic disease
- Lower and upper incisors, lower premolar/ first molar
- Full mouth plaque score < 15%
- Adequate space for a dental implant restoration *Patient with previous diagnosis of periodontitis will be required to have a successfully completed course of periodontal treatment before enrolment.
Exclusion Criteria:
- Smokers and vapers
- Acute infection or sinus tract in relation to the tooth that require extraction
- Pregnant or lactating women
- Patient received antibiotic for past 1 month
- Loss of more than 50% buccal or lingual /palatal bone at the time of extraction
- Patient on medication that altered bone metabolism or bone healing such as bisphosphonates, chemotherapeutic drugs or immunosuppressive agents
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 |
|---|---|
|
No Intervention: Self Healing Group
Self healing in extraction socket
|
|
|
Experimental: Autogenous tooth graft
Autogenous tooth grafting in extraction socket
|
Extracted tooth will be grind and processed into bone graft .
This bone graft material will grafted into the extraction socket
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Socket dimensional changes in autogenous tooth graft group and self healing group
Time Frame: 6 months
|
Socket dimensional changes will be measure in clinical and radiographic measure Clinical measure: A stent will be made prior extraction and hole on the stent will be made to standardized measurement. Clinical measurement ( socket height) will be measure during post extraction, 1 month, 3 month and 6 month to observe the value of the resorption of the extraction socket . The discrepancy value is will be from ( 1month -baseline, 3month-baseline, 6month- baseline) Radiographic measure: CBCT will be taken post extraction 3 month and 6month. Socket width will be measure in 3mm below the socket and 5 mm below the socket. Other than that, mimic software will be used for the volumetric changes. |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Volumetric changes in autogenous tooth group and self healing group
Time Frame: 6 months
|
In this , mimic software will be used for volumetric changes
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- RMC/JANUARY/2025/EC07
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
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.
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