| CTRI Number |
CTRI/2024/05/067069 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study effect of Ayurvedic Toothpaste in avoiding recurrence of dental calculus after scaling. |
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Scientific Title of Study
|
An Open Labelled Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Dantashodhana Paste After Scaling Treatment In Preventing Recurrence Of Dantasharkara (Dental Calculus) |
| Trial Acronym |
Nil |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sobha Yadav |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 406
Department of Shalakya Tantra
Parul Ayurved Hospital
Parul University Limda Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
8708180052 |
| Fax |
|
| Email |
sobha290498@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Manisha Naringe |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 406
Department of Shalakya Tantra
Parul Ayurved Hospital
Parul University Limda Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
9726073938 |
| Fax |
|
| Email |
manishanaringe@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manisha Naringe |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 406
Department of Shalakya Tantra
Parul Ayurved Hospital
Parul University Limda Vadodara
GUJARAT 391760 India |
| Phone |
9726073938 |
| Fax |
|
| Email |
manishanaringe@gmail.com |
|
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Source of Monetary or Material Support
|
| Parul Institute of Ayurved, Parul University, Vadodara, Gujarat, 391760 |
|
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Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul University, Vadodara, Gujarat, 391760 |
| Type of Sponsor |
Other [Teaching Hospital of Parul Institute of Ayurved] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sobha Yadav |
Parul Ayurved Hospital |
OPD No.112, Shalakya Tantra OPD, Parul Ayurved Hospital, Parul University Dr Sobha Yadav PO Limda Tal Waghodia Vadodara 391760 Vadodara GUJARAT |
8708180052
sobha290498@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Parul Institute of Ayurved,Parul University |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K036||Deposits [accretions] on teeth. Ayurveda Condition: Dantasharkara, (2) ICD-10 Condition:K089||Disorder of teeth and supporting structures, unspecified. Ayurveda Condition: DANTASARKARA, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | leKana-karma, लेख़न-करà¥à¤® | (Procedure Reference: SU/CHI 22/36-37,42,CH/SU26/43, Procedure details: Procedure details: The paste should be applied all over the teeth & gingiva with an index finger & then rubbed gently. pressure will be given for 3 to 4 minutes in horizontal, vertical and circular directions.) (1) Medicine Name: Meswak toothpaste, Reference: Dabur, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 0.25(g), Frequency: bd, Duration: 1 Months | | 2 | Intervention Arm | Procedure | - | leKana-karma, लेख़न-करà¥à¤® | (Procedure Reference: SU/CHI22/36-37,42,CH/SU26/43,, Procedure details: Procedure details: The paste should be applied all over the teeth & gingiva with an index finger & then rubbed gently. pressure will be given for 3 to 4 minutes in horizontal, vertical & circular direction.
) (1) Medicine Name: Madhu laksha paste, Reference: SU/CHI22/36-37,42,CH/SU26/43,, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 0.25(g), Frequency: bd, Duration: 1 Months |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having Dental Plaque and Supragingival Calculus deposition with any two of the other
symptoms like pain, inflammation, bleeding gums and halitosis will be included for the
present clinical trial.
2 If the patient visits within 5 days after getting the scaling done then he/she will be included
for the present clinical trial.
3 Selection will be irrespective of Gender, Religion & Socio-economic status.
|
|
| ExclusionCriteria |
| Details |
1 Patients having any known case of Cardiac disorders (such as arrythmia, hypertension and
coronary artery disease) and Blood disorders (such as anemia, haemophilia, blood clots and
blood cancer).
2 Patients who require surgical interventions like gingivectomy or gingivoplasty are excluded
from the study.
3 Patients with adverse habits like tobacco and alcohol consumption. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Preventing the recurrence of Dantasharkara (Dental Calculus) |
15th day, 30th day and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves oral health.Reduces the risk of recurrence. |
6 months to 1 year. |
|
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Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
01/06/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Introduction: Ayurveda texts have described the Mukha Roga (diseases affecting the oral cavity) and mentioned the dental diseases under the heading of Danta (teeth) and Dantamula (gum) disease. There are eight types of Danta Rogas (dental disorders) described in the samhithas like Ashtanga and Sushrutha, where Dantasharkara (dental calculus) has been described as one of the Danta Rogas. When gravel like dirt is deposited and fixed on teeth, destroying the normal characteristic of teeth, it is known as Dantasharkara. The symptoms of Dantasharkara and Dental calculus are similar and thus are correlated. As per classics, Dantasharkara, which is explained in Mukharoga under Danta roga diseases, is due to improper oral hygiene by which the vitiated vata dries the kapha and dantamala. As per the symptoms, we can correlate Dantasharkara with Dental Calculus. Dental Calculus is one among the factors in the initiation and progression of a variety of oral diseases. According to the modern science, dental calculus is a hard deposit that forms by the mineralization of dental plaque and is usually covered by a layer of unmineralized plaque. Dental plaque results from colonization and growth of microorganisms on the tooth surface, if not treated in time it may exacerbate the condition leading to gingivitis, periodontal diseases and even tooth loss. Precipitation of the mineral salts into plaque starts between the 1st and the 14th day of plaque formation, and further it leads to Dental calculus over a period of time. In most of the cases plaque deposition leads to calculus formation, gingivitis, periodontitis, and other oral diseases causing gingival recession, bone resorption and finally tooth mobility and loss of tooth.
Aim: To evaluate the efficacy of Dantashodhana paste after scaling in preventing the recurrence of Dantasharkara (Dental Calculus).Objectives: 1.To study the disease of Dantasharkara in detail according to samhithas. 2. To study the diseases like Dental plaque and Calculus in detail according to the Modern science. 3.To study the effect of Laksha and Madhu paste in the management of Dantasharkara with its properties in detail along with the probable mode of action.
Hypothesis: Null hypothesis (H0): Dantashodhana paste is not effective in the management of post scaling procedure in preventing the recurrence of Dantasharkara (Dental calculus). Alternate hypothesis (H1): Dantashodhana paste is effective in the management of post scaling procedure in preventing the recurrence of Dantasharkara (Dental calculus).
Material & Methods : Sources of Data 1. Literature sources: Literary aspect of the disease Dantasharkara will be studied from Bruhatrayi, laghutarayi, other samhita’s and scientific journals, Published articles and internet sources. Relevant literature of the diseases Dental plaque and Calculus will be studied from Modern texts and various sources related to it. 2. Pharmaceutical sources: For conducting the study, purchase of raw material of all ingredients from Parul Ayurveda Pharmacy. Formulation of the drug will be done under the guidance of Parul Ayurveda Pharmacy of Parul Ayurveda Hospital, Parul University, Limda, Waghodia 3. Clinical sources: Patients complaining of symptoms of Dantasharkara, fulfilling the inclusion criteria will be selected irrespective of religion, caste from the O.P.D of Shalakya Tantra Department or referred from other department of Parul Ayurveda Hospital, Limda.Informed consent will be obtained from all the patients before including them in the present study.
Methods of Collection of Data: Study Design: Type of study- It is an open labelled randomized controlled clinical study between two groups. Group A (Trial group) - Scaling will be done and followed by Dantashodhana paste along with routine oral hygiene. Group B (Control group) - Scaling will be done which will be followed by Dabur Meswak Toothpaste along with routine oral hygiene maintenance. Study centre: Parul Institute of Ayurveda, Parul Ayurved Hospital. Sample size: 24 in each group. Study duration: 60 days. Methods of Randomization: Computerized randomization. Consent : Before commencement of study a written informed consent and assent will be taken.Before and after treatment Observation will be done. Ethical clearance: The study will be started only after obtaining the clearance from the institutional Ethical committee
Investigation and test: BT, CT Salivary pH before and after scaling. Salivary pH before and after applying paste.
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