NCT04239378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

December 27, 2019

Last Update Submit

January 29, 2020

Conditions

Alveolar Bone Resorption

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Plaque Index

    6months

  • Bleeding Index

    6 months

  • Patient Reported Outcome Measures for Pain and Esthetics

    6 months

Study Arms (2)

Test group -Autogenous dentin matrix and collagen membrane

EXPERIMENTAL

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

Control group-bovine derived xenograft and collagen membrane

ACTIVE COMPARATOR

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

Interventions

socket preservationPROCEDURE

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

Control group-bovine derived xenograft and collagen membraneTest group -Autogenous dentin matrix and collagen membrane

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krishnadevaray College of Dental Science and Hospital

Bangalore, Karnataka, 562157, India

RECRUITING

Study Officials

  • DR.JOANN PAULINE GEORGE, MDS

    KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.JOANN PAULINE GEORGE, MDS

CONTACT

9448541637drjoannpaulinegeorge@gmail.com

Dr.SALMA BANU C, MDS

CONTACT

8792625900salmaakram200931@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 27, 2020

Study Start

December 10, 2019

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)