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

K

Krishnadevaraya College of Dental Sciences & Hospital

Status

Unknown

Conditions

Alveolar Bone Resorption

Treatments

Procedure: socket preservation

Study type

Interventional

Funder types

Other

Identifiers

NCT04239378
02_D012_101639

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Test group -Autogenous dentin matrix and collagen membrane
Experimental group
Description:
Test group - After atraumatic tooth extraction , socket will be augmented with autogenous dentin matrix and covered with collagen membrane and sutures are placed.
Treatment:
Procedure: socket preservation
Control group-bovine derived xenograft and collagen membrane
Active Comparator group
Description:
control group- After atraumatic tooth extraction, socket will be augmented with bovine derived xenograft and covered with collagen membrane and sutures are placed.
Treatment:
Procedure: socket preservation

Trial contacts and locations

1

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Central trial contact

Dr.JOANN PAULINE GEORGE, MDS; Dr.SALMA BANU C, MDS

Data sourced from clinicaltrials.gov

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