| CTRI Number |
CTRI/2026/02/103165 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of herbal and chemical mouthwash in patients with gum disease |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of Moringa oleifera mouthwash versus 0.2% Chlorhexidine gluconate mouthwash as an adjunct to scaling and root planing in the treatment of patients with chronic generalized gingivitis-A clinical study |
| Trial Acronym |
Not |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Gupta |
| Designation |
Post graduate student in periodontology |
| Affiliation |
The Oxford dental college |
| Address |
The Oxford dental college, Department of Periodontology, Room no 3, second floor, NH 44, Hosur road, cluster b, Bommanahalli, near Hongasandra metro station, bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
9279068445 |
| Fax |
|
| Email |
guptadrpriyanka22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAmita Coutinho |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford dental college, NH 44, Hosur road, cluster b, Bommanahalli, near Hongasandra metro station, bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
9279068445 |
| Fax |
|
| Email |
guptadrpriyanka22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gupta |
| Designation |
Post graduate student in periodontology |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, NH 44, Hosur road, cluster b, Bommanahalli, near Hongasandra metro station, bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
9279068445 |
| Fax |
|
| Email |
guptadrpriyanka22@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Priyanka Gupta |
| Address |
The Oxford Dental College, NH 44, Hosur road, cluster b, Bommanahalli, near Hongasandra metro station, bengaluru |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Gupta |
The Oxford Dental College |
Department of Periodontology, room no 3, The Oxford Dental College, NH 44, Hosur road, cluster b, near Hongasandra metro station, bengaluru
Bangalore
KARNATAKA |
9279068445
guptadrpriyanka22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient having moderate-to-severe gingivitis, with plaque index (PI) score 1, gingival index (GI) 1, and papillary bleeding index (PBI) 1 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subjects will be asked to rinse their mouth with 0.2% Chlorhexidine.
mouthwash twice a day for 20 days |
All the subjects will undergo an oral examination on day 1 (baseline) of the study. The
baseline score will be recorded for the patients who satisfy the inclusion criteria and will be recorded at baseline and follow-up during morning and evening hours. The
participants will receive a common toothpaste and mouthwash with the labels removed and coded with an alphabet. At the initial visit, the participants will be given instructions on the use of the assigned mouthwash, and their Plaque Index and Gingival index
will be recorded. They will be asked to use 5 ml of mouthwash twice daily, after breakfast and before bedtime, for 20 days. At the end of the 20 days, the participants will be recalled, and their plaque scores and gingival scores will be evaluated. The parameters will be recorded again for all two
groups, and the efficacy of chlorhexidine in reducing plaque, bleeding on probing, pocket depth, gingival enlargement will be
compared. |
| Comparator Agent |
Subjects will be asked to rinse their mouth with Distilled Water twice a day for 20 days. |
All the subjects will undergo an oral examination on day 1 (baseline) of the study. The
baseline score will be recorded for the patients who satisfy the inclusion criteria and will be recorded at baseline and follow-up during morning and evening hours. The
participants will receive a common toothpaste and mouthwash with the labels removed and coded with an alphabet. At the initial visit, the participants will be given instructions on the use of the assigned mouthwash, and their Plaque Index and Gingival index
will be recorded. They will be asked to use 5 ml of mouthwash twice daily, after breakfast and before bedtime, for 20 days. At the end of the 20 days, the participants will be recalled, and their plaque scores and gingival scores will be evaluated. The parameters will be recorded again for all two
groups, and the efficacy of Distilled water in reducing plaque, bleeding on probing, pocket depth, gingival enlargement will be
compared. |
| Intervention |
Subjects will be asked to rinse their mouth with Moringa oleifera mouthwash twice a day for 20 days. |
All the subjects will undergo an oral examination on day 1 (baseline) of the study. The
baseline score will be recorded for the patients who satisfy the inclusion criteria and will be recorded at baseline and follow-up during morning and evening hours. The
participants will receive a common toothpaste and mouthwash with the labels removed and coded with an alphabet. At the initial visit, the participants will be given instructions on the use of the assigned mouthwash, and their Plaque Index and Gingival index
will be recorded. They will be asked to use 5 ml of mouthwash twice daily, after breakfast and before bedtime, for 20 days. At the end of the 20 days, the participants will be recalled, and their plaque scores and gingival scores will be evaluated. The parameters will be recorded again for all two
groups, and the efficacy of Moringa oleifera in reducing plaque, bleeding on probing, pocket depth, gingival enlargement will be
compared. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Both genders with age 25 to 55 years, Systemically healthy subjects, Subjects who have been diagnosed by a periodontist with moderate to severe chronic generalized gingivitis definition will be based on classification of periodontitis as proposed in 2017 World Workshop, Healthy subjects with no history of allergy to any ingredient in mouthwash, Subjects having moderate-to-severe gingivitis, with plaque index (PI) score less than ,gingival index (GI) less than 1, and papillary bleeding index (PBI) less than 1 |
|
| ExclusionCriteria |
| Details |
Subjects with history of systemic disease including diabetes mellitus,cardiovascular, cancer, significant hepatic and renal impairment, neurologic and psychiatric disorder, and immunodeficiency, Subjects who had received periodontal treatment during the 6 months before
the study, Pregnant or lactating women, Subjects who had taken antibiotics or anti-inflammatory drugs within the last three months, Subjects who have habits of smoking or drinking alcohol, Subjects with periodontitis stage III and stage IV. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Following clinical parameters will be recorded
Gingival index (GI), Plaque Index (PI), Bleeding and probing, Probing pocket depths (PPD)at baseline and after 20 days at baseline( day 1) and after 20 day. |
The Following clinical parameters will be recorded
Gingival index (GI), Plaque Index (PI), Bleeding and probing, Probing pocket depths (PPD)at baseline and after 20 days at baseline( day 1) and after 20 day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
12/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [guptadrpriyanka22@gmail.com].
- For how long will this data be available start date provided 01-11-2025 and end date provided 03-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Subgingival bacteria and dental plaque accumulation initiate gingival inflammation. If left
untreated, this causes gingivitis and eventually progresses to periodontitis, with destruction
of the underlying supporting tissue and alveolar bone. The most effective way of
preventing the development of gingival inflammation is by controlling dental plaque
formation as well as proper supportive periodontal maintenance such as personal and
professional care. The gold standard for chemical plaque control used worldwide is
chlorhexidine gluconate (CHX), a broad-spectrum antimicrobial agent that has been shown
to reduce plaque and gingival inflammation. However, long-term use of CHX
mouthwashes can cause adverse effects such as tooth and tongue staining, altered taste
perception, and calculus formation. To combat this, various alteration have been proposed, one such herbal alternative is the
Moringa oleifera (MO) plant. MO provides beneficial nutrients and medical properties.
MO is known as the miracle tree, with various therapeutic properties such as
hepatoprotective, antioxidant, anti-inflammatory, anti-ulcer, anti-cancer, antihypoglycemic, anti-plasmodic, anti-bacterial, and anti-fungal activities. Their role as an
antitumor, anti-inflammatory, and antibacterial agent is also proven. The use of moringa
has an impact on various oral bacteria, namely Porphyromonas gingivalis, Prevotella
intermedia, Staphylococcus aureus, and Streptococcus mutans. Therefore, moringa plant
extracts can be utilized to treat oral conditions such as gingival and periodontal diseases,
oral ulcers, and caries that are caused by these pathogenic bacteria. Despite the lack of research of its use in the human population, the anti-inflammatory and
antiplaque effects of moringa still remains to be explored. Hence, the aim of this study is comparative evaluation of the efficacy of Moringa oleifera
(MO) mouthwash versus 0.2% chlorhexidine mouthwash as an adjunct to scaling and root
planing in the treatment of patients with chronic generalized gingivitis. |