Tooth Graft of Two Different Particle Sizes in Extraction Sockets

NCT04377178 | Unknown

• 1 other identifier: SVSIDS/PERIO/4/2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Socket Preservation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Dentin chips group from automated mill

EXPERIMENTAL

Dentin particles prepared from dentin grinder will be placed in extraction socket immediately after extraction

Device: Dentin grinder

Manually milled Dentin chips

ACTIVE COMPARATOR

Dentin particles prepared from bone mill will be placed in extraction socket immediately after extraction.

Device: Bone mill

Interventions

Dentin grinder DEVICE

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

Dentin chips group from automated mill

Bone mill DEVICE

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

Manually milled Dentin chips

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (2)

R V Chandra

Hyderabad, Telangana, 509002, India

RECRUITING

Svs Institute of Dental Sciences

Hyderabad, Telangana, 509002, India

RECRUITING

Central Study Contacts

RV Chandra, MDS; DNB

CONTACT

9908183071; viswachandra@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 6, 2020
• Study Start: May 25, 2019
• Primary Completion: September 25, 2020
• Study Completion: December 1, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)