Chronic PeriodontitisNCT07531823
Evaluation of Indian Gooseberry/ Amla in the Management of Chronic Periodontitis
A study testing Scaling and root planing + Amla and Scaling and root planing in people with Chronic Periodontitis, run by Mahatma Gandhi Postgraduate Institute of Dental Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Scaling and root planing + Amla and Scaling and root planing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 20 Mar 2020to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Mahatma Gandhi Postgraduate Institute of Dental Sciences
Puducherry, Puducherry, 605006
About this study
Official title: 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.
- At baseline, all participants fulfilling the I/E criteria would be randomized into Arm I or II.
- All participants in Arm I and II would undergo scaling and root planing (SRP).
- After 1 month, Arm I participants would receive adjunct amla for 2 weeks, and Arm II participants would receive no treatment.
- Both arms would be followed until the end of 6 months and evaluated for clinical and biochemical parameters.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- Scaling and root planing + Amla, Scaling and root planing
- Keywords
- chronic periodontitis, Emblica officinalis (amla), antioxidant
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planing + AmlaDietary supplement
Also called Emblica officinalis
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.
Scaling and root planingOther
Chronic generalized patients were randomly assigned to Arm I and Arm II. Arm II participants underwent scaling and root planing only.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in clinical parameters (plaque index)
Improvement in plaque index
Measured: 1, 3 and 6 months
Improvement in clinical parameters (gingival index)
Improvement in gingival index
Measured: 1,3 and 6 months
Improvement in clinical parameters (bleeding index)
Improvement in bleeding index
Measured: 1,3 and 6 months
Improvement in clinical parameters (probing pocket depth)
Improvement in probing pocket depth
Measured: 1,3 and 6 months
Improvement in clinical parameters (clinical attachment level)
Improvement in clinical attachment level
Measured: 1,3 and 6 months
Secondary outcomes (4)
Changes in antioxidant levels (Malondialdehyde) in saliva and serum
Changes in levels of Malondialdehyde
Measured: 6 months
Changes in antioxidant levels (glutathione) in saliva and serum
Changes in glutathione levels
Measured: 6 months
Changes in anti-inflammatory marker levels (CRP) in serum and saliva
Changes in C reactive protein levels
Measured: 6 months
Changes in anti-inflammatory marker levels (TNF-alpha) in serum and saliva
Changes in TNF-alpha levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start20 Mar 2020
- Primary completion15 Mar 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahatma Gandhi Postgraduate Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Grace Tara Paul, Mahatma Gandhi Postgraduate Institute of Dental Sciences
- Investigators
- Grace T Paul, MDS, Principal investigator, Mahatma Gandhi Postgraduate Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531823
- Sponsor's protocol ID
- MGPGIDS
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital has a SOP for data Sharing. The request should come through a proper channel, only then the individual patient data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Amla (Emblica Officinalis) as an Adjunct to Non-surgical Periodontal Therapy in Patients With Chronic Periodontitis -A Clinical and Biochemical Study
- ClinicalTrials.gov ID
- NCT07531823
- Acronym / sponsor ID
- MGPGIDS
- Conditions
- Chronic Periodontitis
- Keywords
- chronic periodontitis, Emblica officinalis (amla), antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahatma Gandhi Postgraduate Institute of Dental SciencesUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- At baseline, all participants fulfilling the I/E criteria would be randomized into Arm I or II.
- All participants in Arm I and II would undergo scaling and root planing (SRP).
- After 1 month, Arm I participants would receive adjunct amla for 2 weeks, and Arm II participants would receive no treatment.
- Both arms would be followed until the end of 6 months and evaluated for clinical and biochemical parameters.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planing + Amla | Active comparator | Dietary Supplement: Scaling and root planing + AmlaArm 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. |
| Scaling and root planing | Sham comparator | Other: Scaling and root planingArm II - This group of chronic generalized periodontitis patients received the standard of care i.e. scaling and root planing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and root planing + AmlaAlso: Emblica officinalisChronic 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. | Dietary supplement | Scaling and root planing + Amla |
| Scaling and root planingChronic generalized patients were randomly assigned to Arm I and Arm II. Arm II participants underwent scaling and root planing only. | Other | Scaling and root planing |
Primary outcome
Improvement in clinical parameters (plaque index)
Time frame: 1, 3 and 6 months
Improvement in plaque index
Improvement in clinical parameters (gingival index)
Time frame: 1,3 and 6 months
Improvement in gingival index
Improvement in clinical parameters (bleeding index)
Time frame: 1,3 and 6 months
Improvement in bleeding index
Improvement in clinical parameters (probing pocket depth)
Time frame: 1,3 and 6 months
Improvement in probing pocket depth
Improvement in clinical parameters (clinical attachment level)
Time frame: 1,3 and 6 months
Improvement in clinical attachment level
4 secondary outcomes
Changes in antioxidant levels (Malondialdehyde) in saliva and serum
Time frame: 6 months
Changes in antioxidant levels (glutathione) in saliva and serum
Time frame: 6 months
Changes in anti-inflammatory marker levels (CRP) in serum and saliva
Time frame: 6 months
Changes in anti-inflammatory marker levels (TNF-alpha) in serum and saliva
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. Hospital has a SOP for data Sharing. The request should come through a proper channel, only then the individual patient data can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace T Paul, MDS principal investigator
Mahatma Gandhi Postgraduate Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing + Amla and Scaling and root planing in people with Chronic Periodontitis, run by Mahatma Gandhi Postgraduate Institute of Dental Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in clinical parameters (plaque index) (time frame: 1, 3 and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.