Intrabony Periodontal DefectNCT06426524
Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study
A study testing IGF-1 Gel and Hydroxyapatite in people with Intrabony Periodontal Defect, run by Dr R Viswa Chandra at 1 site in India.
Trial summary
The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects. 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?
- IGF-1 Gel and Hydroxyapatite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 19 May 2023to May 2024
- 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 Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of >5mm.
Who cannot join
- Medically compromised patients Pregnant women Heavy smokers 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 Viswa Chandra, MDS; DNB, 9908183071, viswachandra@hotmail.com
About this study
The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects.
Read the detailed description
In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed.
In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- IGF-1 Gel, Hydroxyapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGF-1 GelProcedure or surgery
After degranulation of the defect, IGF-1 gel mixed with Hydroxyapatite graft will be placed in the defect.
HydroxyapatiteProcedure or surgery
After degranulation of the defect, Hydroxyapatite graft will be placed in the defect.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed. Receives: Procedure: IGF-1 Gel |
| Control group | Active comparator | In control group, after reflection of flap and degranulation, 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.
Bone Regeneration
Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
Measured: 3 months and 6 months
clinical attachment level
Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.
Measured: 3 months and 6 months
Probig depth
Assessment of probing depth using UNC-15 probe at baseline and postoperatively at 3 and 6 months.
Measured: 3 months and 6 months
Secondary outcomes (1)
Plaque Index
Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start19 May 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr R Viswa Chandra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426524
- Sponsor's protocol ID
- SVSInstituteDS1
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study
- ClinicalTrials.gov ID
- NCT06426524
- Acronym / sponsor ID
- SVSInstituteDS1
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dr R Viswa ChandraUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 23 May 2024 (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 aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects.
Detailed description
In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed.
In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: IGF-1 GelIn test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed. |
| Control group | Active comparator | Procedure: HydroxyapatiteIn control group, after reflection of flap and degranulation, 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 Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of >5mm.
Key exclusion criteria (1 listed)
- Medically compromised patients Pregnant women Heavy smokers 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 |
|---|---|---|
| IGF-1 GelAfter degranulation of the defect, IGF-1 gel mixed with Hydroxyapatite graft will be placed in the defect. | Procedure or surgery | Test group |
| HydroxyapatiteAfter degranulation of the defect, Hydroxyapatite graft will be placed in the defect. | Procedure or surgery | Control group |
Primary outcome
Bone Regeneration
Time frame: 3 months and 6 months
Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
clinical attachment level
Time frame: 3 months and 6 months
Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.
Probig depth
Time frame: 3 months and 6 months
Assessment of probing depth using UNC-15 probe at baseline and postoperatively at 3 and 6 months.
1 secondary outcome
Plaque Index
Time frame: 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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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 IGF-1 Gel and Hydroxyapatite in people with Intrabony Periodontal Defect, run by Dr R Viswa Chandra 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 23 May 2024. 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 Dr R Viswa Chandra, MDS;DNB;PhD (8179367147, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Regeneration (time frame: 3 months and 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 23 May 2024.