Comparison of Autogenous Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation

Study Overview
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Brief Summary
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The present study is a human, prospective, randomised controlled clinical trial will be conducted to explore and compare the clinical, radiographic and histomorphometric outcome of autogenous demineralised dentin(DDM) versus bovine derived xenograft(DBM) for socket preservation procedure.

Detailed Description
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After local anesthesia a full thickness flap will be minimally reflected buccally and lingually around the tooth not exceeding 3mm apical to the alveolar crest. Tooth extraction will be performed using atraumatic extraction methods using Periotome. After extraction, the socket will be thoroughly curetted, inspected and irrigated with sterile saline solution. The socket satisfying the inclusion and exclusion criteria will be randomly allocated to either test or control group. Intra surgical measurements will be recorded. Socket preservation will be performed with either Demineralized dentin matrix DDM(TEST) or bovine derived xenograft DBM (CONTROL). Bone graft will be extended to the height of intra proximal bone. Collagen membrane will be placed over the grafted site extending approximately 3mm apical to buccal and lingual crest. Flaps will be approximated with sutures.

Official Title
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Clinical, Radiographic and Histomorphometric Comparison of Autogenous Demineralized Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation: A Randomised Controlled Clinical Trial

Conditions
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Alveolar Bone Resorption

Intervention / Treatment
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* Procedure: socket preservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Teeth indicated for extraction and subsequent implant placement Age group of 18 to 55 years Single rooted tooth indicated for extraction due to endodontic failure, caries or Fracture Presence of >2 mm keratinized tissue to allow flap management Extraction site should have adjacent tooth on either side Systemically healthy patients Class II or III extraction socket defects according to Hammerele and Jung(2008) Full mouth plaque score(FMPS)<25% at baseline.(PI) Full mouth bleeding score(FMBS)<25% at baseline. (BI) Exclusion Criteria: .Presence of dehiscence or fenestration in any of the socket, more than 50% of bone loss in any of the socket walls Medical conditions contraindicating surgical interventions Known smokers and alcoholics Subjects with known bone metabolic disorders.(Pagets disease,fibrous dysplasia etc.) Acute infections at the site of extraction. Eg , Abscess History of malignancy Patients who have undergone radiotherapy or chemotherapy Periapical pathology such as granulomas, cyst, hypercementosis, ankylosis. Pregnant and lactating women Maxillary and mandibular 3rd molars.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: Test group -Autogenous dentin matrix and collagen membrane<br>Test group - After atraumatic tooth extraction , socket will be augmented with autogenous dentin matrix and covered with collagen membrane and sutures are placed. | Procedure: socket preservation<br>* Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)<br>|
| Active Comparator: Control group-bovine derived xenograft and collagen membrane<br>control group- After atraumatic tooth extraction, socket will be augmented with bovine derived xenograft and covered with collagen membrane and sutures are placed. | Procedure: socket preservation<br>* Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height of Alveolar Crest and Bucco-Lingual Ridge Width | Using Mapping Caliper and (University of North Carolina) UNC- 15 PROBE Measured in mm | 6 Months | 
| Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG) | CBCT (Cone Beam Computer Tomography) measured in mm | 6 MONTHS | 
| New Bone Formation % and Residual Bone Graft | HISTOMORPHOMETRIC | 6 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Silness and Leo index using UNC-15 PROBE with Rating Score Excellent- 0 Good- 0.1 - 0.9 Fair -1.0 - 1.9 Poor - 2.0 - 3.0 | 6months | 
| Bleeding Index | Mombelli - Sulcus Bleeding Index using UNC-15 Probe with Rating Score 0- No bleeding 1 -Isolated bleeding spots visible 2-Blood forms a confluent red line on the margin 3- Heavy or profuse bleeding | 6 months | 
| Patient Reported Outcome Measures for Pain and Esthetics | ( Visual Analog Scale -VAS) Rating score, None (0) Mild (1-3) Moderate (4-6) Severe (7-10) | 6 months |