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

NCT07531823 | Completed

• 1 other identifier: MGPGIDS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.At baseline, all participants fulfilling the I/E criteria would be randomized into Arm I or II.
2. 2.All participants in Arm I and II would undergo scaling and root planing (SRP).
3. 3.After 1 month, Arm I participants would receive adjunct amla for 2 weeks, and Arm II participants would receive no treatment.
4. 4.Both arms would be followed until the end of 6 months and evaluated for clinical and biochemical parameters.

Conditions

Chronic Periodontitis

Keywords

chronic periodontitis; Emblica officinalis (amla); antioxidant

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Changes in antioxidant levels (Malondialdehyde) in saliva and serum

  6 months

• Changes in antioxidant levels (glutathione) in saliva and serum

  6 months

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

  6 months

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

  6 months

Study Arms (2)

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.

Dietary Supplement: Scaling and root planing + Amla

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

Other: Scaling and root planing

Interventions

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.

Also known as: Emblica officinalis

Scaling and root planing + Amla

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.

Scaling and root planing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahatma Gandhi Postgraduate Institute of Dental Sciences: lead

Study Sites (1)

Mahatma Gandhi Postgraduate Institute of Dental Sciences

Puducherry, Puducherry, 605006, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Grace T Paul, MDS

  Mahatma Gandhi Postgraduate Institute of Dental Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 15, 2026
• Study Start: March 20, 2020
• Primary Completion: March 15, 2022
• Study Completion: September 15, 2022
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)