Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin

Study Overview
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Brief Summary
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Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Ridge preservation aims to maximize the bone formation accompanied with good soft tissue architecture to facilitate implant and prosthetic replacement restoring function, phonetics and aesthetics. the Aim of the study is To evaluate the bucco-lingual ridge width clinically and radiographically, height of buccal and lingual ridges of the socket after application of injectable platelet rich fibrin and autogenous dentin graft.

Official Title
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Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin (A Randomized Controlled Clinical Trial)

Conditions
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Ridge Preservation, Alveolar Bone Loss, Dentin Graft

Intervention / Treatment
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* Procedure: injectable platelet rich fibrin with demineralized dentin graft
* Procedure: demineralized dentin graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years need of at least one single rooted tooth extraction. Non-restorable teeth. Systemically healthy patients. Good oral hygiene, Plaque index less than 15%. Non-smoker or Smoking ≤ 10 cigarettes/day. Cooperative patients able and accept to come for follow up appointments. Exclusion Criteria: Any interim intervention that may have affected any of the outcomes of interest. Pregnant and lactation females. Smoking ˃ 10 cigarettes/day. Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes). Patients with poor oral hygiene. Any known allergies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: injectable platelet rich fibrin with deminerlized dentin graft<br>injectable platelet rich fibrin with deminerlized dentin graft for ridge preservation after teeth extraction | Procedure: injectable platelet rich fibrin with demineralized dentin graft<br>* after atraumatic extraction, collection of whole venous blood (9 ml) in sterile vacutainer tubes will be done without anticoagulant added, vacutainer tubes will be then placed in a centrifugal machine at 700 revolutions per minute (rpm) for 3 min with a tube filled with water to maintain the balance during the centrifuging process. ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.<br>|
| Active Comparator: deminerlized dentin graft<br>deminerlized dentin graft for ridge preservation after teeth extraction | Procedure: demineralized dentin graft<br>* after atraumatic extraction, ADDG particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Bucco-lingual ridge width change | radiographic measurement | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the height of the socket buccal and lingual ridges. | radiographic measurement | up to 24 weeks | 
| postoperative pain | Visual analogue scale from zero (better) to 10 (worse) | immediately after the procedure | 
| Patient satisfaction | binary yes and no | immediately after the procedure | 
| Keratinized tissue width | periodontal probe measurement | up to 24 weeks | 
| chair time | in minutes | immediately after the procedure |