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 Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Preventing the recurrence of Dantasharkara (Dental Calculus)
Study Overview
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
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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.
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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
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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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Preventing the recurrence of Dantasharkara (Dental Calculus)
Time Frame: 15th day, 30th day and 60th day
Secondary Outcomes
- Improves oral health.Reduces the risk of recurrence.(6 months to 1 year.)
Investigators
Dr Sobha Yadav
Parul Institute of Ayurved