Clinical trial NCT04239378: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Resorption
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Height of Alveolar Crest and Bucco-Lingual Ridge Width
timeFrame: 6 Months
measure: Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG)
timeFrame: 6 MONTHS
measure: New Bone Formation % and Residual Bone Graft
timeFrame: 6 MONTHS
Secondary outcomes:
measure: Plaque Index
timeFrame: 6months
measure: Bleeding Index
timeFrame: 6 months
measure: Patient Reported Outcome Measures for Pain and Esthetics
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaray College of Dental Science and Hospital
state: Karnataka
Study officials:
affiliation: KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCE
name: DR.JOANN PAULINE GEORGE, MDS
role: PRINCIPAL_INVESTIGATOR
References: