Effect of Locally Applied Hyaluronic Acid, Mixed With Autogenous Demineralized Tooth Graft, for Socket Preservation, Versus Autogenous De-mineralized Tooth Graft.

Study Overview
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Brief Summary
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Many dentists, clinicians and researchers have conducted numerous trials, and put several materials and procedures under the test, in an attempt to preserve vertical and/or horizontal extraction sockets dimensions. The clinical consequences of post-extraction remodeling may affect the outcome of the ensuing therapies aimed at restoring the lost dentition, either by limiting the bone availability for ideal implant placement or by compromising the aesthetic result of the prosthetic restorations. In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the edentulous area.

Official Title
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Potential Effect Assessment of Locally Applied Hyaluronic Acid, When Mixed With Autogenous De-mineralized Tooth Graft, for Socket Preservation, in Comparison With the Application of Autogenous De-mineralized Tooth Graft Alone.

Conditions
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Alveolar Bone Resorption, Socket Preservation, Bone Resorption

Intervention / Treatment
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* Procedure: tooth extraction and socket preservation with demineralized tooth graft
* Procedure: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 18 years old or older. 2. Requiring alveolar preservation after tooth extraction prior to placement of dental implant. 3. Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological factors - time related factors). 4. Motivated patients with good enough understanding of oral health measurements and importance. 5. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect. 7. Patients who are healthy or have well-controlled systemic disease(s). 8. Teeth extractions are to be recommended due to trauma, caries, or periodontal diseases. * 9. Single rooted teeth from both arches. 10. No acute infections, pus formation, socket and bony discharges. 11. Hopeless teeth, to be extracted, are bounded both mesially and distally by adjacent, teeth. 12. Intact buccal bone of the teeth to be extracted. Exclusion Criteria: 1. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of >6 mg/ml of nicotine). 2. Presence of active infection or severe inflammation in the intervention zone. 3. Relevant medical history that contraindicates implant surgery. 4. Immunosuppression (eg. Hiv, solid-organ transplants). 5. Head and neck-irradiated patients in the past 5 years. 6. Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories. 7. Chronic drug abuse or alcoholic habits. 8. Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation. 9. Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%). 10. Uncontrolled and /or untreated periodontal disease. 11. Patients who had previously received bone graft on the site to be operated. 12. Patients with significant comorbidity such as recent heart attack or coagulation disorder. 13. Pregnant subjects.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tooth extraction and socket preservation with demineralized tooth graft<br> | Procedure: tooth extraction and socket preservation with demineralized tooth graft<br>* tooth extraction and socket preservation with demineralized tooth graft<br>|
| Experimental: tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid<br> | Procedure: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid<br>* tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (BLRW) | Bucco-lingual alveolar ridge width | 6 months | 
| (BRH) | Height of Buccal ridge | 6 months | 
| (LRH). | height of Lingual ridge | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of newly formed bone |  | 6 months | 
| soft tissue healing | percentage of complete post operative wound closure by soft tissues | 2 weeks | 
| residual graft | percentage of residual bone graft particles | 6 months | 
| Visual analogue score (VAS) | Patient's pain and discomfort, 0-10 score, 0 represents no pain, 10 represents as bad as possible | 2 weeks |