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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Dietary supplement: Scaling and root planing + Amla; Other: Scaling and root planing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Puducherry
    • Puducherry, Puducherry, India, 605006
      • Mahatma Gandhi Postgraduate Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Systemically healthy patients

Exclusion Criteria:

1. Medically compromised patients
2. Smokers
3. Pregnant and lactating women
4. Patients on cholesterol-lowering medication
5. 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.
6. Patients who had undergone any periodontal surgery in the past 6 months
7. Patients with a high caries index
8. Patients with severe tooth hypersensitivity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scaling and root planing + Amla; 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.	Dietary supplement: Scaling and root planing + Amla; 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
Sham Comparator: Scaling and root planing; Arm II - This group of chronic generalized periodontitis patients received the standard of care i.e. scaling and root planing	Other: Scaling and root planing; Chronic generalized patients were randomly assigned to Arm I and Arm II. Arm II participants underwent scaling and root planing only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mahatma Gandhi Postgraduate Institute of Dental Sciences
• Investigators: Principal Investigator: Grace T Paul, MDS, Mahatma Gandhi Postgraduate Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: antioxidant; chronic periodontitis; Emblica officinalis (amla)
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Periodontitis; Pathological Conditions, Signs and Symptoms; Chronic Periodontitis; Digestive System and Oral Physiological Phenomena; Dentistry; Dental Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Subgingival Curettage; Preventive Dentistry; Root Planing; Tooth Exfoliation
• Other Study ID Numbers: MGPGIDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Hospital has a SOP for data Sharing. The request should come through a proper channel, only then the individual patient data can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No