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

NCT ID: NCT04239378

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2021-11-30

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.

Conditions

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Alveolar Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

socket preservation

Intervention Type PROCEDURE

Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)

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.

Group Type ACTIVE_COMPARATOR

socket preservation

Intervention Type PROCEDURE

Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)

Interventions

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socket preservation

Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Prabhuji MLV

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DR.JOANN PAULINE GEORGE, MDS

Role: PRINCIPAL_INVESTIGATOR

KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCE

Locations

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Krishnadevaray College of Dental Science and Hospital

Bangalore, Karnataka, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr.JOANN PAULINE GEORGE, MDS

Role: CONTACT

9448541637

Dr.SALMA BANU C, MDS

Role: CONTACT

8792625900

Facility Contacts

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salma banu, MDS

Role: primary

8792625900 ext. +91

Other Identifiers

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02_D012_101639

Identifier Type: -

Identifier Source: org_study_id

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