Evaluation of Indian Gooseberry/ Amla in the Management of Chronic Periodontitis (NCT07531823) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Indian Gooseberry/ Amla in the Management of Chronic Periodontitis
India30 participantsStarted 2020-03-20
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Patients who have at least 20 remaining teeth, with chronic generalized periodontitis, as defined as \> 30 % sites involved (extent) and with moderate to severe involvement (severity) as characterized by \> 2 interproximal sites with clinical attachment loss (CAL) \> 4mm (not on the same tooth) AND/OR \> 5 mm, probing depth (not on the same tooth) AND/OR \> 2 interproximal sites with CAL \> 6 mm AND 1 interproximal site with PD \> 5mm.
✓. Systemically healthy patients
Exclusion criteria
✕. Medically compromised patients
✕. Smokers
✕. Pregnant and lactating women
✕. Patients on cholesterol-lowering medication
✕. Patients who had received any antimicrobial therapy in the past 2 months, on ongoing antimicrobial therapy, or would receive antimicrobials during the course of the study.
✕. Patients who had undergone any periodontal surgery in the past 6 months
✕
What they're measuring
1
Improvement in clinical parameters (plaque index)
Timeframe: 1, 3 and 6 months
2
Improvement in clinical parameters (gingival index)
Timeframe: 1,3 and 6 months
3
Improvement in clinical parameters (bleeding index)
Timeframe: 1,3 and 6 months
4
Improvement in clinical parameters (probing pocket depth)
Timeframe: 1,3 and 6 months
5
Improvement in clinical parameters (clinical attachment level)
Timeframe: 1,3 and 6 months
Trial details
NCT IDNCT07531823
SponsorMahatma Gandhi Postgraduate Institute of Dental Sciences