Clinical trial NCT03790605: A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Periodontitis
Keywords: periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta
Lead sponsor: KLE Society's Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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 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


Eligibility criteria: Inclusion Criteria:

1. Systemically healthy individuals
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 Criteria:

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

Primary outcomes:
measure: Cytokine parameter
timeFrame: Change from Baseline to 4 weeks
Secondary outcomes:
measure: Probing pocket depth
timeFrame: Changes from Baseline to 4 weeks and 12 weeks
measure: Clinical attachment level
timeFrame: Changes from Baseline to 4 weeks and 12 weeks
measure: Gingival Bleeding Index by Loe and Silness in 1963
timeFrame: Changes from Baseline to 4 weeks and 12 weeks
measure: Plaque index by Silness and Loe in 1964
timeFrame: Baseline from. 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: K L E society's Dental College
state: Karnataka
Study officials:
References: