| CTRI Number |
CTRI/2025/07/091377 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A comparative analysis of Lata Kasturi (Muskmallow) extract with scaling and root planing for treatment of periodontitis |
|
Scientific Title of Study
|
A Comparative Evaluation of Efficacy of Systemically and Locally Delivered Muskmallow (Abelmoschus moschatus) Seed Extracts as an Adjunct to Scaling And Root Planing in Generalized Moderate to Severe Chronic Periodontitis Patients: A Randomized Double Blinded Placebo Controlled Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhu Varma |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital, Chhatrapati Sambhajinagar |
| Address |
Room no 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar Near Jain Mandir Road, Darwha, Dist. Yavatmal Aurangabad MAHARASHTRA 431001 India |
| Phone |
7744860111 |
| Fax |
|
| Email |
varmamadhu66@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr C D Dhalkari |
| Designation |
Professor and Head in Department of Periodontology |
| Affiliation |
Room no 154, Government Dental College and Hospital, Chhatrapati Sambhajinagar |
| Address |
Room no 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9422204639 |
| Fax |
|
| Email |
drcddhalkari@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr C D Dhalkari |
| Designation |
Professor and Head in Department of Periodontology |
| Affiliation |
Room no 154, Government Dental College and Hospital, Chhatrapati Sambhajinagar |
| Address |
Room no 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar
MAHARASHTRA 431001 India |
| Phone |
9422204639 |
| Fax |
|
| Email |
drcddhalkari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Governmental Dental college and Hospital, Navkhanda, Chhatrapati Sambhajinagar, Maharashtra, India
pincode 431001 |
|
|
Primary Sponsor
|
| Name |
Dr. Madhu Varma |
| Address |
Room no 154, first floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar |
| Type of Sponsor |
Other [Self] |
|
|
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 Madhu Varma |
Government Dental College and Hospital |
Room no 154, 1st floor, Department of periodontology, Government Dental College and Hospital, Navkhanda, Chhatrapati Sambhajinagar
Near Jain Mandir Road, Darwha, Dist. Yavatmal Aurangabad MAHARASHTRA |
7744860111
varmamadhu66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Dental College and Hospital, Chhatrapati Sambhajinagar, Maharashtra |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Muskmallow (Lata Kasturi) , Reference: Dravagun Vidnyan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tinospora cordifolia , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Tinospora cordifolia is a placebo material inert in nature | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Muskmallow (Lata Kasturi), Reference: Dravagun Vidnyan, Route: Topical, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 10ml mouthwash twice daily 30 minutes after brushing for 2 minutes Squish and Spit | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Muskmallow (Lata Kasturi), Reference: Dravagun Vidnyan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Combination of Muskmallow Tablets and Mouthwash |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with generalized moderate to severe chronic periodontitis.
2. Patients in age group of 30 - 65 years of either sex.
3. Patients with at least 20 natural teeth.
4. Patient ready to give written informed consent.
5. Systemically healthy patients.
|
|
| ExclusionCriteria |
| Details |
1. Patients on antibiotic or antimicrobial therapy in last 6 months.
2. Smokers and smokeless tobacco users.
3. Patients who have received periodontal treatment in the past 6 months.
4. Pregnant and lactating mothers.
5. Patients allergic to any material used in study
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Gingival index
Papillary bleeding Index
Plaque index
Probing pocket depth
Pocket probing depth
Clinical attachment loss
Radiographic evaluation of bone level |
1week
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical attachment loss
Radiographic evaluation of bone level |
1 week
1 month |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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 2 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Oral health is integral to general health and essential for wellbeing. Despite impressive improvements in oral health because of much better oral hygiene maintenance, problems still remain in many places around the world1. Oral cavity is a favourable habitat for a variety of bacteria due to the constant presence of nutrients and secretions. Some bacteria of normal oral flora are pathogenic and cause harm to the host. Many of these organisms are responsible for the formation of plaque which in turn is responsible for diseases like dental caries, gingivitis and periodontitis. Mechanical removal of dental biofilm is a key factor in the prevention of oral diseases. The tools most commonly used in mechanical plaque control are the toothbrushes (manual or electric), floss, woodsticks and interdental brushes11. Despite the availability of various oral hygiene devices, even the most meticulous person will not always completely remove all the plaque. The recognized inadequacies in the mechanical plaque control practices of many individuals has fuelled a year-long search for chemical agents to control plaque. Chemotherapeutic mouthrinses endow with chemically significant benefit in the reduction of plaque induced gingivitis. Mouthrinses encompass the ability to deliver therapeutic ingredients and benefits to all accessible surfaces in the mouth including interproximal surfaces. They also remain effective for unmitigated period of time depending on their substantivity. Mature, intact biofilms hinder the action of chemotherapeutic agents. Hence antimicrobial agents have to be used adjunctively to scaling and root planing and not as first line of treatment in the management of periodontitis. To date no single chemotherapeutic agent is found to target all pathogens harbouring the periodontal pocket. These limitations force us to use a combination of antimicrobials and a judicious selection of antimicrobials targeting the pathogens is quite essential. But synthetic antimicrobials and anti-inflammatory agent have side effects and result in complications like drug resistance, gastrointestinal complications, congestive heart failures, renal failures, allergic reactions, which may at times be life-threatening. Also there are side effects of various mouthwashes such as tooth and tongue staining, taste alterations, and mucosal erosions that limit patient compliance. Today dentists are practicing in an era where the patients are more concerned about their oral health and their overall wellbeing. Thus, in the midst of growing evidence of the connection between oral and systemic health, herbal medicines with their ‘naturally occurring’ active ingredients offer a gentle and enduring solution for restoration of health in a more trustworthy and least harmful way. Traditional medicine is deep rooted and grounded deep in India and is being used here since times immemorial. Ayurvedic medicine is a system used by Indians and is native to the Indian subcontinent as a form of alternative medicine. It has also attracted much attention in developed countries such as Europe, United States and Japan. Charka samhita and Sushutra samhita have been the basis of ayurvedic medicine since a long time. Rationale During past two decades reliability and usage of herbal products has assumed increasing importance, due to the side effects and complications of many chemical and synthetic medicines. About 25% of drugs are derived from plants and many other are formed from prototype compounds isolated from plant species. These medicines contain natural phytochemicals in them and offer an effective alternative to antibiotics and represent a promising approach in the prevention and therapeutic strategies for oral infections too. Because of relatively safe nature of herbal extracts, many herbal products and their component are being used for treating periodontitis in the form of local drug delivery as well systemically. Therefore, the purpose of this study was to evaluate the effects of systemic and locally delivered Muskmallow (Abelmoschus moschatus) seed extracts as an adjunct to scaling and root planing in patients with generalized moderate to severe chronic periodontitis. |