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Completed

NCT Number: NCT07531823

Evaluation of Indian Gooseberry/ Amla in the Management of Chronic Periodontitis

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahatma Gandhi Postgraduate Institute of Dental Sciences

Puducherry, 605006, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patients with a high caries index
  • Patients with severe tooth hypersensitivity

Treatment and study plan

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.

Other names: Emblica officinalis

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.

Primary outcomes

  1. Improvement in clinical parameters (plaque index)

    Time frame: 1, 3 and 6 months

    Improvement in plaque index

  2. Improvement in clinical parameters (gingival index)

    Time frame: 1,3 and 6 months

    Improvement in gingival index

  3. Improvement in clinical parameters (bleeding index)

    Time frame: 1,3 and 6 months

    Improvement in bleeding index

  4. Improvement in clinical parameters (probing pocket depth)

    Time frame: 1,3 and 6 months

    Improvement in probing pocket depth

  5. Improvement in clinical parameters (clinical attachment level)

    Time frame: 1,3 and 6 months

    Improvement in clinical attachment level

Secondary outcomes

  1. Changes in antioxidant levels (Malondialdehyde) in saliva and serum

    Time frame: 6 months

    Changes in levels of Malondialdehyde

  2. Changes in antioxidant levels (glutathione) in saliva and serum

    Time frame: 6 months

    Changes in glutathione levels

  3. Changes in anti-inflammatory marker levels (CRP) in serum and saliva

    Time frame: 6 months

    Changes in C reactive protein levels

  4. Changes in anti-inflammatory marker levels (TNF-alpha) in serum and saliva

    Time frame: 6 months

    Changes in TNF-alpha levels

Sponsors and collaborators

Lead sponsor

Mahatma Gandhi Postgraduate Institute of Dental Sciences

Other

Registry information

Official study title

Evaluation of Amla (Emblica Officinalis) as an Adjunct to Non-surgical Periodontal Therapy in Patients With Chronic Periodontitis -A Clinical and Biochemical Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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