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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 % curcumin chip | Drug | CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth | Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups | Changes from Baseline to 4 weeks and 12 weeks |
| Clinical attachment level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riya A Daniel, BDS, PG student | Contact | 9444140560 | +91 | riyaad.rd@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K L E society's Dental College | Recruiting | Bangalore | Karnataka | 560022 | India |
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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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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Total subjects = 40 INCLUSION 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
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The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject
| Placebo chip | Other | PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle |
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| Scaling and root planing | Procedure | Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips |
|
Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
| 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 | 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 | Baseline from. 4 weeks, 12 weeks |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |