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Clinical Trials/NCT04239378
NCT04239378
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Clinical, Radiographic and Histomorphometric Comparison of Autogenous Demineralized Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation: A Randomised Controlled Clinical Trial

Krishnadevaraya College of Dental Sciences & Hospital1 site in 1 country20 target enrollmentDecember 10, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alveolar Bone Resorption
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Enrollment
20
Locations
1
Primary Endpoint
Height of Alveolar Crest and Bucco-Lingual Ridge Width
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2019
End Date
November 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Prabhuji MLV

PROFESSOR

Krishnadevaraya College of Dental Sciences & Hospital

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.

Outcomes

Primary Outcomes

Height of Alveolar Crest and Bucco-Lingual Ridge Width

Time Frame: 6 Months

Using Mapping Caliper and (University of North Carolina) UNC- 15 PROBE Measured in mm

New Bone Formation % and Residual Bone Graft

Time Frame: 6 MONTHS

HISTOMORPHOMETRIC

Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG)

Time Frame: 6 MONTHS

CBCT (Cone Beam Computer Tomography) measured in mm

Secondary Outcomes

  • Plaque Index(6months)
  • Bleeding Index(6 months)
  • Patient Reported Outcome Measures for Pain and Esthetics(6 months)

Study Sites (1)

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