Tooth Graft of Two Different Particle Sizes in Extraction Sockets

Socket Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04377178
• Other study ID #: SVSIDS/PERIO/4/2018
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2019
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: SVS Institute of Dental Sciences
• Contact: RV Chandra, MDS; DNB
• Phone: 9908183071
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Socket Preservation

Intervention

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
• 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

Locations

Country	Name	City	State
India	R V Chandra	Hyderabad	Telangana
India	Svs Institute of Dental Sciences	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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