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

Primary Purpose

Alveolar Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
socket preservation
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Krishnadevaray College of Dental Science and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group -Autogenous dentin matrix and collagen membrane

Control group-bovine derived xenograft and collagen membrane

Arm Description

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- After atraumatic tooth extraction, socket will be augmented with bovine derived xenograft and covered with collagen membrane and sutures are placed.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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)

Full Information

First Posted
December 27, 2019
Last Updated
January 29, 2020
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04239378
Brief Title
Comparison of Autogenous Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation
Official Title
Clinical, Radiographic and Histomorphometric Comparison of Autogenous Demineralized Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation: A Randomised Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group -Autogenous dentin matrix and collagen membrane
Arm Type
Experimental
Arm Description
Test group - After atraumatic tooth extraction , socket will be augmented with autogenous dentin matrix and covered with collagen membrane and sutures are placed.
Arm Title
Control group-bovine derived xenograft and collagen membrane
Arm Type
Active Comparator
Arm Description
control group- After atraumatic tooth extraction, socket will be augmented with bovine derived xenograft and covered with collagen membrane and sutures are placed.
Intervention Type
Procedure
Intervention Name(s)
socket preservation
Intervention Description
Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)
Primary Outcome Measure Information:
Title
Height of Alveolar Crest and Bucco-Lingual Ridge Width
Description
Using Mapping Caliper and (University of North Carolina) UNC- 15 PROBE Measured in mm
Time Frame
6 Months
Title
Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG)
Description
CBCT (Cone Beam Computer Tomography) measured in mm
Time Frame
6 MONTHS
Title
New Bone Formation % and Residual Bone Graft
Description
HISTOMORPHOMETRIC
Time Frame
6 MONTHS
Secondary Outcome Measure Information:
Title
Plaque Index
Description
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
Time Frame
6months
Title
Bleeding Index
Description
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
Time Frame
6 months
Title
Patient Reported Outcome Measures for Pain and Esthetics
Description
( Visual Analog Scale -VAS) Rating score, None (0) Mild (1-3) Moderate (4-6) Severe (7-10)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.JOANN PAULINE GEORGE, MDS
Phone
9448541637
Email
drjoannpaulinegeorge@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.SALMA BANU C, MDS
Phone
8792625900
Email
salmaakram200931@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DR.JOANN PAULINE GEORGE, MDS
Organizational Affiliation
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krishnadevaray College of Dental Science and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
salma banu, MDS
Phone
8792625900
Ext
+91
Email
salmaakram200931@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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