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

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

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.

Study Overview

• Status: Unknown
• Conditions: Alveolar Bone Resorption
• Intervention / Treatment: Procedure: socket preservation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr.JOANN PAULINE GEORGE, MDS; Phone Number: 9448541637; Email: drjoannpaulinegeorge@gmail.com
• Study Contact Backup: Name: Dr.SALMA BANU C, MDS; Phone Number: 8792625900; Email: salmaakram200931@gmail.com

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Recruiting
      • Krishnadevaray College of Dental Science and Hospital
      • Contact: salma banu, MDS; Phone Number: +91 8792625900; Email: salmaakram200931@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group -Autogenous dentin matrix and collagen membrane; 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; Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)
Active Comparator: Control group-bovine derived xenograft and collagen membrane; 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; Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Principal Investigator: DR.JOANN PAULINE GEORGE, MDS, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCE

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: 02_D012_101639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No