Mahatma Gandhi Postgraduate Institute of Dental Sciences
Puducherry, 605006, India
NCT Number: NCT07531823
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.
1. At baseline, all participants fulfilling the I/E criteria would be randomized into Arm I or II. 2. All participants in Arm I and II would undergo scaling and root planing (SRP). 3. After 1 month, Arm I participants would receive adjunct amla for 2 weeks, and Arm II participants would receive no treatment. 4. Both arms would be followed until the end of 6 months and evaluated for clinical and biochemical parameters.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Puducherry, 605006, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Emblica officinalis
Chronic generalized patients were randomly assigned to Arm I and Arm II. Arm II participants underwent scaling and root planing only.
Time frame: 1, 3 and 6 months
Improvement in plaque index
Time frame: 1,3 and 6 months
Improvement in gingival index
Time frame: 1,3 and 6 months
Improvement in bleeding index
Time frame: 1,3 and 6 months
Improvement in probing pocket depth
Time frame: 1,3 and 6 months
Improvement in clinical attachment level
Time frame: 6 months
Changes in levels of Malondialdehyde
Time frame: 6 months
Changes in glutathione levels
Time frame: 6 months
Changes in C reactive protein levels
Time frame: 6 months
Changes in TNF-alpha levels
Mahatma Gandhi Postgraduate Institute of Dental Sciences
Other
Evaluation of Amla (Emblica Officinalis) as an Adjunct to Non-surgical Periodontal Therapy in Patients With Chronic Periodontitis -A Clinical and Biochemical Study
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