PeriodontitisPhase 3NCT03790605
A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis
A Phase 3 study testing 1 % curcumin chip and Scaling and root planing in people with Periodontitis, run by KLE Society's Institute of Dental Sciences at 1 site in India.
Trial summary
The study will follow a parallel arm, randomised, double blinded, placebo controlled design. There will be two groups Group 1 = receiving 1% curcumin chips after routine scaling and root planing (n=20) Group 2 = receiving placebo chips after routine scaling and root planing (n=20) Clinical parameters: ( Baseline, 4… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- 1 % curcumin chip and Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 4 Sep 2019to 1 Dec 2020
- Phase
- Phase 3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals
- Presence of a minimum of 20 teeth in the oral cavity
- Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP)
Who cannot join
- Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose
- Systemic diseases and/or Inflammatory conditions, Obesity
- Former or current tobacco users
- Chronic consumption of alcohol
- Use of anti-inflammatory drugs and antibiotics over the past 3 months
- Periodontal therapy in any form, surgical or non surgical in the past 6 months
- Pregnant and lactating mothers
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
K L E society's Dental College
Bangalore, Karnataka, 560022
Riya Daniel, BDS, 9444140560 ext. +91, riyaad.rd@gmail.com
About this study
Official title: Evaluation of the Host Modulating Effects of 1% Curcumin Chips as an Adjunct to Non Surgical Mechanical Debridement in the Treatment of Periodontitis: A Randomised Controlled Clinical Trial
The study will follow a parallel arm, randomised, double blinded, placebo controlled design.
There will be two groups Group 1 = receiving 1% curcumin chips after routine scaling and root planing (n=20) Group 2 = receiving placebo chips after routine scaling and root planing (n=20) Clinical parameters: ( Baseline, 4 weeks, 12 weeks) Probing pocket depth, clinical attachment level, gingival index, plaque index Cytokine parameter ( Baseline, 4 weeks) Interleukin 1 beta in GCF
Statistical analysis Repeated measures of ANOVA Paired t-tests
- Conditions
- Periodontitis
- Being tested
- 1 % curcumin chip, Placebo chip, Scaling and root planing
- Keywords
- periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 % curcumin chipDrug
CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle
Placebo chipOther
PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle
Scaling and root planingProcedure or surgery
Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips
| Study group | Role | What they receive |
|---|---|---|
| 1% curcumin chip | Experimental | Following routine full mouth scaling and root planing within 48 hours, a single chip of 1% curcumin will be placed locally within a single isolated periodontal pocket(the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip(second placement) Receives: Drug: 1 % curcumin chip; Procedure: Scaling and root planing |
| Placebo chip | Placebo comparator | Following routine full mouth scaling and root planing within 48 hours, a single placebo chip will be placed locally within a single isolated periodontal pocket (the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip (second placement) Receives: Other: Placebo chip; Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine parameter
Intragroup comparison within each group (1-curcumin group and 2- placebo group) and intergroup comparison between the two groups of levels of interleukin 1 beta in the gingival crevicular fluid quantified by ELISA in picogram per milliliter
Measured: Change from Baseline to 4 weeks
Secondary outcomes (4)
Probing pocket depth
Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
Measured: Changes from Baseline to 4 weeks and 12 weeks
Clinical attachment level
Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
Measured: Changes from Baseline to 4 weeks and 12 weeks
Gingival Bleeding Index by Loe and Silness in 1963
Intragroup within each group ( 1-curcumin group and 2- placebo group) and intergroup comparison between the two group
Measured: Changes from Baseline to 4 weeks and 12 weeks
Plaque index by Silness and Loe in 1964
Intragroup within each group ( 1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
Measured: Baseline from. 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start4 Sep 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total subjects = 40 INCLUSION CRITERION 1. Systemically healthy individuals both males and females of 20-60 years 2. Presence of a minimum of 20 teeth in the oral cavity 3. Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP) EXCLUSION CRITERION 1 Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose 2 Systemic diseases and/or Inflammatory conditions, Obesity 3 Former or current tobacco users 4 Chronic consumption of alcohol 5 Use of anti-inflammatory drugs and antibiotics over the past 3 months 6 Periodontal therapy in any form, surgical or non surgical in the past 6 months 7 Pregnant and lactating mothers
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KLE Society's Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Riya Achamma Daniel, KLE Society's Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790605
- Sponsor's protocol ID
- riya1curcumin
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2018
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the purpose of confidentiality, as will be promised to the participants while signing the informed consent, all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Host Modulating Effects of 1% Curcumin Chips as an Adjunct to Non Surgical Mechanical Debridement in the Treatment of Periodontitis: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03790605
- Acronym / sponsor ID
- riya1curcumin
- Conditions
- Periodontitis
- Keywords
- periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KLE Society's Institute of Dental SciencesUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 31 Dec 2018 (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 study will follow a parallel arm, randomised, double blinded, placebo controlled design.
There will be two groups Group 1 = receiving 1% curcumin chips after routine scaling and root planing (n=20) Group 2 = receiving placebo chips after routine scaling and root planing (n=20) Clinical parameters: ( Baseline, 4 weeks, 12 weeks) Probing pocket depth, clinical attachment level, gingival index, plaque index Cytokine parameter ( Baseline, 4 weeks) Interleukin 1 beta in GCF
Statistical analysis Repeated measures of ANOVA Paired t-tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Total subjects = 40 INCLUSION CRITERION 1. Systemically healthy individuals both males and females of 20-60 years 2. Presence of a minimum of 20 teeth in the oral cavity 3. Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP) EXCLUSION CRITERION 1 Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose 2 Systemic diseases and/or Inflammatory conditions, Obesity 3 Former or current tobacco users 4 Chronic consumption of alcohol 5 Use of anti-inflammatory drugs and antibiotics over the past 3 months 6 Periodontal therapy in any form, surgical or non surgical in the past 6 months 7 Pregnant and lactating mothers
| Arm | Type | Receives |
|---|---|---|
| 1% curcumin chip | Experimental | Drug: 1 % curcumin chip, Procedure: Scaling and root planingFollowing routine full mouth scaling and root planing within 48 hours, a single chip of 1% curcumin will be placed locally within a single isolated periodontal pocket(the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip(second placement) |
| Placebo chip | Placebo comparator | Other: Placebo chip, Procedure: Scaling and root planingFollowing routine full mouth scaling and root planing within 48 hours, a single placebo chip will be placed locally within a single isolated periodontal pocket (the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip (second placement) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy individuals
- Presence of a minimum of 20 teeth in the oral cavity
- Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP)
Key exclusion criteria (7 listed)
- Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose
- Systemic diseases and/or Inflammatory conditions, Obesity
- Former or current tobacco users
- Chronic consumption of alcohol
- Use of anti-inflammatory drugs and antibiotics over the past 3 months
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 |
|---|---|---|
| 1 % curcumin chipCURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle | Drug | 1% curcumin chip |
| Placebo chipPLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle | Other | Placebo chip |
| Scaling and root planingRoutine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips | Procedure or surgery | 1% curcumin chip, Placebo chip |
Primary outcome
Cytokine parameter
Time frame: Change from Baseline to 4 weeks
Intragroup comparison within each group (1-curcumin group and 2- placebo group) and intergroup comparison between the two groups of levels of interleukin 1 beta in the gingival crevicular fluid quantified by ELISA in picogram per milliliter
4 secondary outcomes
Probing pocket depth
Time frame: Changes from Baseline to 4 weeks and 12 weeks
Clinical attachment level
Time frame: Changes from Baseline to 4 weeks and 12 weeks
Gingival Bleeding Index by Loe and Silness in 1963
Time frame: Changes from Baseline to 4 weeks and 12 weeks
Plaque index by Silness and Loe in 1964
Time frame: Baseline from. 4 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No. For the purpose of confidentiality, as will be promised to the participants while signing the informed consent, all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers
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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 Phase 3 study testing 1 % curcumin chip and Scaling and root planing in people with Periodontitis, run by KLE Society's 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 3 inclusion and 7 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 13 Dec 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Riya A Daniel, BDS, PG student (9444140560 ext. +91, riyaad.rd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine parameter (time frame: Change from Baseline to 4 weeks). 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 13 Dec 2019.