| CTRI Number |
CTRI/2024/08/072013 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Usefulness of Kshara Taila in Plaque-induced Gingivitis |
|
Scientific Title of Study
|
Efficacy of Kshara Taila in Plaque induced Gingivitis A Randomized Controlled 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 |
Vishnu Govind M |
| Designation |
Assistant professor |
| Affiliation |
The CVM University |
| Address |
Department of Shalakyatantra,
G J patel Institute of Ayurvedic Studies and Research,
New Vallabh Vidyanagar
Anand GUJARAT 388121 India |
| Phone |
9497525695 |
| Fax |
|
| Email |
vishnu.madhavan@cvmu.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vimal Panchani |
| Designation |
Professor and HOD |
| Affiliation |
The CVM University |
| Address |
Department of Shalakyatantra,
G J patel Institute of Ayurvedic Studies and Research,
New Vallabh Vidyanagar
Anand GUJARAT 388121 India |
| Phone |
9898381314 |
| Fax |
|
| Email |
vimalben.panchani@cvmu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Vishnu Govind M |
| Designation |
Assistant professor |
| Affiliation |
The CVM University |
| Address |
Department of Shalakyatantra,
G J patel Institute of Ayurvedic Studies and Research,
New Vallabh Vidyanagar
GUJARAT 388121 India |
| Phone |
9497525695 |
| Fax |
|
| Email |
vishnu.madhavan@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
| G J Patel Institute of Ayurvedic Studies & Research
New VV Nagar
Anand
388121 |
|
|
Primary Sponsor
|
| Name |
G J Patel Institute of Ayurvedic Studies & Research |
| Address |
Department of Shalakyatantra
G J Patel Institute of Ayurvedic Studies & Research
New VV Nagar
Anand
388121 |
| Type of Sponsor |
Private medical college |
|
|
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 Vishnu Govind M |
S G Patel Ayurveda Hospital & maternity Home |
Department of Shalakyatantra, OP No. 17 Anand GUJARAT |
9497525695
vishnu.madhavan@cvmu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CERTIFICATE OF APPROVAL OF INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: DANTASARKARA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kavalaH | (Procedure Reference: Ashtanga Hrudaya, Sutrasthana, Chapter 22, Procedure details: 15 ml lukewarm oil is swished around the mouth for 15 minutes. Then rinse the mouth with hot water and brush teeth. Foods or drinks can be had immediately.) (1) Medicine Name: Kshara Taila, Reference: Ashtanga Hrudaya, Uttarasthana, 18/26-29, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | 0.2% chlorhexidine | 15 mL 0.2% chlorhexidine is swished around the mouth for one minute, after brushing teeth in the morning. Participant must wait 60 minutes before having something to eat or drink. It must be done continuously for 14 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) An anticipated ability to attend the scheduled visits
2) Having plaque-induced gingivitis (ICD-10-CM Diagnosis Code K05.10)
|
|
| ExclusionCriteria |
| Details |
1) Participants contra-indicated for gandusha or kavalagraha
2) Less than 20 natural teeth
3) Participants who are pregnant or nursing.
4) A dental student or faculty or dental staff member.
5) Usage of fixed or removable orthodontic appliance
6) Clinical loss of periodontal ligament / attachment
7) Recent history of (within two weeks prior to examination), or ongoing, antibiotic therapy.
8) A need for immediate antimicrobial treatment for periodontitis.
9) Continuing use of anticoagulant medications
10) Dry mouth syndrome or significant food allergies.
11) Any dental procedures or oral prophylaxis within 15 days prior to examination
12) Presence of an intraoral soft tissue pathology
13) Smoking
14) Any significant medical condition that contributes to the development of dental plaque (like diabetes, cardiovascular diseases, autoimmune conditions etc)
15) Presence of major physical or mental limitation or restriction that prohibit the hygiene procedures used in the study protocol
16) Any other condition which in the opinion of the investigators places the participant at risk if they were to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Bleeding on probing score (BOP), expressed in percentage. |
8 days after treatment and 16 days after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Modified Gingival Index
2) Modified Plaque Score |
8 days after treatment and 16 days after treatment |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="8" Days="0" |
|
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 - NO
|
|
Brief Summary
|
Plaque-induced gingivitis is generally regarded as a site-specific
inflammatory condition initiated by dental biofilm accumulation and
characterized by gingival redness and edema and the absence of periodontal
attachment loss. The disease is commonly painless, rarely leads to
spontaneous bleeding, and is often characterized by subtle clinical changes
detectable only by trained personnels. Consequently, most patients are either
unaware of it or unable to recognize it. Recent reports suggest that it is
found in 46.6% of the adult Indian population.
The standard treatment of gingivitis is the use of antiseptic
mouthwash containing chlorhexidine. Despite its wide use, chlorhexidine is
recognised as a corrosive, irritant, health hazard and environmental hazard by
the Globally Harmonized System of Classification and Labelling of Chemicals.
Chlorhexidine has known common side effects such as increased plaque, peeling
of oral mucosa, dry mouth, tongue discolouration, teeth sensitivity, altered
taste perception, short bursts of burning sensation, and teeth staining. More recent reviews concluded that the result of kavala /
oil-pulling is comparable to that of chlorhexidine, without showing any side
effects. But the oils tested in these studies— coconut oil, gingelly
oil, olive oil etc.—were randomly chosen based on anecdotes, not based on an
existing guideline from any traditional medicines.
The closest
correlation of plaque-induced gingivitis in Ayurveda is dantasharkara which is
described as a firm accumulation of mala on teeth.
Caused by the lack of dental hygiene leading to the shoshana of kapha by vata,
dantasharkara deteriorates the normal properties of teeth and presents with
halitosis. Since spontaneous bleeding is not specified in this condition, the
clinical picture here is that of stage 2 or 3 gingivitis. Dantasharkara is managed by lekhana
(scraping) and kshara taila avasechana (oil-pulling). Lekhana karma for
dantasharkara has not been standardised yet and the effect of kshara taila oil-pulling
in plaque-induced gingivitis remains to be studied. Hence the current study
intends to evaluate the efficacy of kshara taila oil-pulling in plaque-induced
gingivitis. |