Socket PreservationNCT04377178
Tooth Graft of Two Different Particle Sizes in Extraction Sockets
A study testing Dentin grinder and Bone mill in people with Socket Preservation, run by SVS Institute of Dental Sciences at 2 sites in India.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- Dentin grinder and Bone mill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesIndia
- Study dates
- 25 May 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals within the age group of 20-50 years with presence of teeth with hopeless prognosis requiring extraction
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
R V Chandra
Hyderabad, Telangana, 509002
R V Chandra, MDS;DNB;PhD, 9908183071, viswachandra@hotmail.com
- Recruiting
Svs Institute of Dental Sciences
Hyderabad, Telangana, 509002
Rampalli V Chandra, MDS; DNB, 9908183071, viswachandra@hotmail.com
About this study
Official title: 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.
Read the 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)).
- Conditions
- Socket Preservation
- Being tested
- Dentin grinder, Bone mill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dentin grinderDevice
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 millDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Dentin chips group from automated mill | Experimental | Dentin particles prepared from dentin grinder will be placed in extraction socket immediately after extraction Receives: Device: Dentin grinder |
| Manually milled Dentin chips | Active comparator | Dentin particles prepared from bone mill will be placed in extraction socket immediately after extraction. Receives: Device: Bone mill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline to 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start25 May 2019
- Primary completion25 Sep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket PreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377178
- Sponsor's protocol ID
- SVSIDS/PERIO/4/2018
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Autogenous Tooth Graft of Two Different Particle Sizes in Extraction Socket Preservation: A Comparative Clinical and Radiographical Study
- ClinicalTrials.gov ID
- NCT04377178
- Acronym / sponsor ID
- SVSIDS/PERIO/4/2018
- Conditions
- Socket Preservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- 25 May 2019 (actual)
- Primary completion
- 25 Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dentin chips group from automated mill | Experimental | Device: Dentin grinderDentin particles prepared from dentin grinder will be placed in extraction socket immediately after extraction |
| Manually milled Dentin chips | Active comparator | Device: Bone millDentin particles prepared from bone mill will be placed in extraction socket immediately after extraction. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy individuals within the age group of 20-50 years with presence of teeth with hopeless prognosis requiring extraction
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dentin grinderAfter 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 | Device | Dentin chips group from automated mill |
| Bone millAfter 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 | Device | Manually milled Dentin chips |
Primary outcome
Bone fill
Time frame: Baseline to 6months
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.
Bone density
Time frame: Baseline to 6months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dentin grinder and Bone mill in people with Socket Preservation, run by SVS Institute of Dental Sciences at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RV Chandra, MDS; DNB (9908183071, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone fill (time frame: Baseline to 6months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.