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

Not Applicable

• Conditions: Alveolar Bone Resorption
• Interventions: Procedure: socket preservation

• Registration Number: NCT04239378
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary

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

* 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.

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2019-12-27
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-27
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-02-05
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group -Autogenous dentin matrix and collagen membrane	socket preservation	Test group - After atraumatic tooth extraction , socket will be augmented with autogenous dentin matrix and covered with collagen membrane and sutures are placed.
Control group-bovine derived xenograft and collagen membrane	socket preservation	control group- After atraumatic tooth extraction, socket will be augmented with bovine derived xenograft and covered with collagen membrane and sutures are placed.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plaque Index	6months	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
Bleeding Index	6 months	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
Patient Reported Outcome Measures for Pain and Esthetics	6 months	( Visual Analog Scale -VAS) Rating score, None (0) Mild (1-3) Moderate (4-6) Severe (7-10)

Trial Locations

Locations (1)

Krishnadevaray College of Dental Science and Hospital; 🇮🇳 Bangalore, Karnataka, India