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

Alveolar Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239378
• Other study ID #: 02_D012_101639
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: November 2021

Study information

• Verified date: January 2020
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: Dr.JOANN PAULINE GEORGE, MDS
• Phone: 9448541637
• Email: drjoannpaulinegeorge[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

Intervention

Procedure:
• socket preservation
Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)

Locations

Country	Name	City	State
India	Krishnadevaray College of Dental Science and Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG)	CBCT (Cone Beam Computer Tomography) measured in mm	6 MONTHS
Primary	New Bone Formation % and Residual Bone Graft	HISTOMORPHOMETRIC	6 MONTHS
Secondary	Plaque Index	Silness and Leo index using UNC-15 PROBE with Rating Score Excellent- 0 Good- 0.1 - 0.9 Fair -1.0 - 1.9 Poor - 2.0 - 3.0	6months
Secondary	Bleeding Index	Mombelli - Sulcus Bleeding Index using UNC-15 Probe with Rating Score 0- No bleeding; 1 -Isolated bleeding spots visible 2-Blood forms a confluent red line on the margin 3- Heavy or profuse bleeding	6 months
Secondary	Patient Reported Outcome Measures for Pain and Esthetics	( Visual Analog Scale -VAS) Rating score, None (0) Mild (1-3) Moderate (4-6) Severe (7-10)	6 months