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This study aimed to evaluate the influence of amla (Emblica officinalis) on patients with chronic generalized periodontitis, using a single-blind, randomized controlled study design.
The study is a randomized, single-blind, controlled trial, involving thirty chronic generalized periodontitis patients aged between 25 to 60 years. Participants fulfilling the Inclusion/ Exclusion criteria participants would be randomized to Arm I or II. They would be subjected to scaling and root planing (SRP). After 1 month, Arm I participants would be given amla for 2 weeks, while no adjunct therapy is planned for the participants in Arm II. Clinical parameters such as plaque index, gingival index, bleeding index, probing pocket depth, and clinical attachment loss would be assessed at baseline, 1, 3 and 6 months post-treatment. Biochemical parameters malondialdehyde (MDA) and glutathione (GTH) would be measured by spectrophotometry, while ELISA would be performed to assess the tumor necrosis factor-α (TNF- α), and C-reactive protein (CRP) in serum and saliva, at baseline and 6 months. Statistical analysis is proposed using SPSS or STATA 14 package.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and root planing + Amla | Active Comparator | Arm I - This group of chronic generalized periodontitis patients would receive the standard of care i.e. scaling and root planing, followed by a full amla berry daily for 2 weeks. |
|
| Scaling and root planing | Sham Comparator | Arm II - This group of chronic generalized periodontitis patients received the standard of care i.e. scaling and root planing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and root planing + Amla | Dietary Supplement | Chronic generalized patients were randomly assigned to Arm I and Arm II. Arm I participants underwent scaling and root planing followed by consumption of a whole amla berry. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical parameters (plaque index) | Improvement in plaque index | 1, 3 and 6 months |
| Improvement in clinical parameters (gingival index) | Improvement in gingival index | 1,3 and 6 months |
| Improvement in clinical parameters (bleeding index) | Improvement in bleeding index | 1,3 and 6 months |
| Improvement in clinical parameters (probing pocket depth) | Improvement in probing pocket depth | 1,3 and 6 months |
| Improvement in clinical parameters (clinical attachment level) | Improvement in clinical attachment level | 1,3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in antioxidant levels (Malondialdehyde) in saliva and serum | Changes in levels of Malondialdehyde | 6 months |
| Changes in antioxidant levels (glutathione) in saliva and serum | Changes in glutathione levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace T Paul, MDS | Mahatma Gandhi Postgraduate Institute of Dental Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahatma Gandhi Postgraduate Institute of Dental Sciences | Puducherry | Puducherry | 605006 | India |
Hospital has a SOP for data Sharing. The request should come through a proper channel, only then the individual patient data can be shared.
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| 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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The study is a single-blind, randomized controlled trial, where one arm receives scaling and root planing along with amla (after 1 month of SRP). The other arm receives only scaling and root planing.
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The investigator and outcome assessor were not aware of the arms or the intervention received. The additional intervention (amla dispensing) was conducted by another member, not involved in the study.
|
| Scaling and root planing | Other | Chronic generalized patients were randomly assigned to Arm I and Arm II. Arm II participants underwent scaling and root planing only. |
|
| 6 months |
| Changes in anti-inflammatory marker levels (CRP) in serum and saliva | Changes in C reactive protein levels | 6 months |
| Changes in anti-inflammatory marker levels (TNF-alpha) in serum and saliva | Changes in TNF-alpha levels | 6 months |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |