Periodontitis
Conditions
Keywords
periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta
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
Interventions
DRUG1 % curcumin chip
CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle
OTHERPlacebo chip
PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle
PROCEDUREScaling and root planing
Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips
Sponsors
KLE Society's Institute of Dental Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytokine parameter | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth | Changes from Baseline to 4 weeks and 12 weeks | Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups |
| Clinical attachment level | Changes from Baseline to 4 weeks and 12 weeks | Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups |
| Gingival Bleeding Index by Loe and Silness in 1963 | Changes from Baseline to 4 weeks and 12 weeks | Intragroup within each group ( 1-curcumin group and 2- placebo group) and intergroup comparison between the two group |
| Plaque index by Silness and Loe in 1964 | Baseline from. 4 weeks, 12 weeks | Intragroup within each group ( 1- curcumin group and 2- placebo group) and intergroup comparison between the two groups |
Countries
India
Contacts
Primary ContactRiya A Daniel, BDS, PG student
Outcome results
None listed