Tooth Graft of Two Different Particle Sizes in Extraction Sockets

Comparison of Autogenous Tooth Graft of Two Different Particle Sizes in Extraction Socket Preservation: A Comparative Clinical and Radiographical Study

The primary objective of the present study is to clinically and radiographically evaluate the efficacy of autogenous tooth graft obtained from bone mill and dental grinder to preserve alveolar ridge dimensions in extraction sockets.

Study Overview

• Status: Unknown
• Conditions: Socket Preservation
• Intervention / Treatment: Device: Dentin grinder; Device: Bone mill

Detailed Description

Accordingly, teeth will be used as a test material to allow for comparative tests after processing it in the automated milling system (AMS). The material will be moistened and then placed in toto into the extraction sockets to generate particles at settings 1 (500 RPM for 30s) or 2 (900 RPM for 30s) to generate MS and SS respectively ((SS group; 0.5-0.8 mm) and medium size (MS group; 1.0-1.2 mm)).

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 509002
      • Recruiting
      • SVS Institute of Dental Sciences
      • Contact: Rampalli V Chandra, MDS; DNB; Phone Number: 9908183071; Email: viswachandra@hotmail.com
    • Hyderabad, Telangana, India, 509002
      • Recruiting
      • R V Chandra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Systemically healthy individuals within the age group of 20-50 years with presence of teeth with hopeless prognosis requiring extraction

Exclusion Criteria:

• Medically compromised patients.
• Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
• Patients having uncontrolled periodontal disease or having an active sinus infection.
• Smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dentin chips group from automated mill; Dentin particles prepared from dentin grinder will be placed in extraction socket immediately after extraction	Device: Dentin grinder; After atraumatic extraction of the tooth, autogenous dentin particles are made with the help of a device - dentin grinder from the separated root and these particles are incorporated into the extraction socket
Active Comparator: Manually milled Dentin chips; Dentin particles prepared from bone mill will be placed in extraction socket immediately after extraction.	Device: Bone mill; After atraumatic extraction of the tooth, autogenous dentin particles are made with the help of a device - Bone mill from the separated root and these particles are incorporated into the extraction socket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone fill	The radiograph obtained at 3 and 6 months will be subtracted from the radiograph taken at the baseline by using commercially available image processing software (Adobe Photoshop® 6.0, Adobe Systems, San Jose, USA). After digital subtraction, the digitized and excluded residual bone height will be transferred to open source software for area calculation (ImageJ®, Research Services Branch, NIH, Bethesda, Maryland, USA) for area calculation. The area of the layer will be calculated (in mm2) by initially enclosing the entire area with the rectangular selection tool and then by using Analyze>Analyze Particles tool.	Baseline to 6months
Bone density	Radiographs will be taken with digitalized RVG machine (DX 3000, DEXCOWN portable dental X-ray system) at 60Kvp/2Ma with inactive interface. RVG images taken at baseline and 6 months will be utilized to evaluate bone mineral density through Hounsfield units (HU).	Baseline to 6months

Collaborators and Investigators

• Sponsor: SVS Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2019
• Primary Completion (Anticipated): September 25, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SVSIDS/PERIO/4/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No