Intrabony Periodontal DefectNCT04932161
Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects
A study testing Titanium Granules and Hydroxyapatite in people with Intrabony Periodontal Defect, run by SVS Institute of Dental Sciences at 1 site in India.
Trial summary
The ideal goal of the periodontal treatment is not only to prevent the progression of the disease, but also the regeneration and reconstruction of lost tissues. Many surgical techniques have been used to regenerate intrabony defects (IBD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Titanium Granules and Hydroxyapatite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2021to Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy male and female patients of age >18 years with two-walled or three-walled intrabony defects and probing pocket depths (PPD) of >3mm.
Who cannot join
- Medically compromised patients, patients <18 years of age, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy are excluded.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
SVS Institute of Dental Sciences, Mahabubnagar
Hyderabad, Telangana, 509002
Rampalli V Chandra, MDS; DNB, 9908183071, viswachandra@hotmail.com
About this study
Official title: Comparative Efficacy of Titanium Granules Over Hydroxyapatite in the Treatment of Periodontal Intrabony Defects: A Clinico-radiographic Study
The ideal goal of the periodontal treatment is not only to prevent the progression of the disease, but also the regeneration and reconstruction of lost tissues. Many surgical techniques have been used to regenerate intrabony defects (IBD).
Titanium stimulates activation of the complement system, surface binding of platelets, and platelet activation as reflected by increased levels of platelet-derived growth factor, which is a substantial promoter of bone growth. Hence we may speculate that using a bone substitute made of titanium may be positive from the perspective of bone formation in osseous defects.
Read the detailed description
Titanium granules consist of irregular porous granules of commercially pure titanium. The porous properties may lead to ingrowth of newly formed bone.The osseointegrating response to titanium may be the result of the potent activation of the intrinsic coagulation system and the subsequent release of growth factors from platelets.Therefore, the aim of this study is to compare the effect of titanium particles and hydroxyapatite on osseous regeneration in intrabony defects.
After reflection of flap and degranulation, bone graft i.e., titanium particles (test group) or hydroxyapatite(control group) will be placed in the void created by the defect and sutures will be placed.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Titanium Granules, Hydroxyapatite
- Keywords
- Intrabony defects, Titanium Granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium GranulesProcedure or surgery
After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.
HydroxyapatiteProcedure or surgery
After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.
| Study group | Role | What they receive |
|---|---|---|
| Titanium Granules as a bone graft in intrabony defects | Experimental | In test group, after reflection of flap and degranulation, bone graft i.e., titanium particles will be placed in the void created by the defect and sutures will be placed. Receives: Procedure: Titanium Granules |
| Hydroxyapatite as a bone graft in intrabony defects | Active comparator | In control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed. Receives: Procedure: Hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.
Measured: from baseline to 6 months
Probing Depth
Assessment of probing depth using University of North Carolina(UNC)-15 probe at baseline and postoperatively at 3 and 6 months.
Measured: from baseline to 6 months
Bone Regeneration
Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
Measured: at 3 months and 6 months
Secondary outcomes (2)
Plaque Index
Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.
Measured: from baseline to 6 months
Gingivitis
Assessment of Gingivitis (GI) - according to Loe H and Silness P, 1963.
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study startAug 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 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
- NCT04932161
- Sponsor's protocol ID
- SVSIDS/PERIO/4/2020
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Titanium Granules Over Hydroxyapatite in the Treatment of Periodontal Intrabony Defects: A Clinico-radiographic Study
- ClinicalTrials.gov ID
- NCT04932161
- Acronym / sponsor ID
- SVSIDS/PERIO/4/2020
- Conditions
- Intrabony Periodontal Defect
- Keywords
- Intrabony defects, Titanium Granules
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Jun 2021 (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 ideal goal of the periodontal treatment is not only to prevent the progression of the disease, but also the regeneration and reconstruction of lost tissues. Many surgical techniques have been used to regenerate intrabony defects (IBD).
Titanium stimulates activation of the complement system, surface binding of platelets, and platelet activation as reflected by increased levels of platelet-derived growth factor, which is a substantial promoter of bone growth. Hence we may speculate that using a bone substitute made of titanium may be positive from the perspective of bone formation in osseous defects.
Detailed description
Titanium granules consist of irregular porous granules of commercially pure titanium. The porous properties may lead to ingrowth of newly formed bone.The osseointegrating response to titanium may be the result of the potent activation of the intrinsic coagulation system and the subsequent release of growth factors from platelets.Therefore, the aim of this study is to compare the effect of titanium particles and hydroxyapatite on osseous regeneration in intrabony defects.
After reflection of flap and degranulation, bone graft i.e., titanium particles (test group) or hydroxyapatite(control group) will be placed in the void created by the defect and sutures will be placed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium Granules as a bone graft in intrabony defects | Experimental | Procedure: Titanium GranulesIn test group, after reflection of flap and degranulation, bone graft i.e., titanium particles will be placed in the void created by the defect and sutures will be placed. |
| Hydroxyapatite as a bone graft in intrabony defects | Active comparator | Procedure: HydroxyapatiteIn control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Systemically healthy male and female patients of age >18 years with two-walled or three-walled intrabony defects and probing pocket depths (PPD) of >3mm.
Key exclusion criteria (1 listed)
- Medically compromised patients, patients <18 years of age, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy are excluded.
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 |
|---|---|---|
| Titanium GranulesAfter degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured. | Procedure or surgery | Titanium Granules as a bone graft in intrabony defects |
| HydroxyapatiteAfter degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured. | Procedure or surgery | Hydroxyapatite as a bone graft in intrabony defects |
Primary outcome
Clinical Attachment Level
Time frame: from baseline to 6 months
Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.
Probing Depth
Time frame: from baseline to 6 months
Assessment of probing depth using University of North Carolina(UNC)-15 probe at baseline and postoperatively at 3 and 6 months.
Bone Regeneration
Time frame: at 3 months and 6 months
Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
2 secondary outcomes
Plaque Index
Time frame: from baseline to 6 months
Gingivitis
Time frame: from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium Granules and Hydroxyapatite in people with Intrabony Periodontal Defect, run by SVS Institute of Dental Sciences at 1 site 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 1 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 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 R V Chandra, MDS;DNB;PhD (9908183071, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (time frame: from baseline to 6 months). The study lists 3 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 21 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.