Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies
NCT ID: NCT06575335
Last Updated: 2025-02-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-09-30
Study Completion Date
2024-11-07
Brief Summary
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This double-blind randomized clinical trial will be conducted among differently abled institutionalized children. Sixty participants aged 6-12 years with mild intellectual disability (ID) will be enrolled in the study and divided into two treatment groups. The participants will be allocated in either of the two treatment arms through Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) by the principal investigator. One group will receive triphala tooth wipes and the other will be given chlorhexidine tooth wipes, both for 7 days twice a day. Supragingival plaque sample will be collected from the buccal surface of the permanent maxillary first molar and will be subjected to microbial analysis for Streptococcus mutans (S. mutans) colonies using colony-forming units per millilitre (CFU/ml).
The tooth wipes will be prepared by the principal investigator under supervision of Pharmacognosist at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan.
The tooth wipes will be prepared by the principal investigator under supervision of Pharmacognosist at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan.
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Detailed Description
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Preparation of Tooth Wipes:
Preparation of Triphala Tooth Wipes- The triphala decoction will be prepared by the principal investigator at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan under the supervision of Pharmacognocist. The three fruits of triphala will be bought in powder form from an ayurvedic drug vendor. A mixture will be made by combining equal proportion of all these three powders in distilled water. This will then be boiled till the volume reduces to 1/8th part of the initial volume.
A sweetener will be added to the decoction followed by filtering using a white muslin cloth and then storing in a sterile amber-coloured glass bottle in a refrigerator. This will preserve its organoleptic properties and its quality for fourteen days.
The decoction obtained will be subjected to dilution to obtain concentration. This will then be used to impregnate the marketed tooth wipes fabric. The triphala tooth wipes will be cut, folded individually, and then packed using the wet wipes machine in a plain white packing by local pharmaceutical company. Each pack will contain 16 wipes.
Preparation of Chlorhexidine Tooth Wipes- The commercially available chlorhexidine mouthwash containing will be purchased from the market and will then be used to impregnate the marketed tooth wipes fabric. The chlorhexidine tooth wipes will be cut, folded individually, and then packed using the wet wipes machine in a plain white packing by local pharmaceutical company. Each pack will contain 16 wipes.
Data Collection:
Consent- Before initiation of the study, informed consent will be taken from the parent and/or guardian.
Proforma- The questionnaire will consist of their demographic details and Intelligence Quotient (IQ) score. The Streptococcus mutans count will be assessed on day 1 and day 7 of the intervention.
IQ Score- Mild ID having IQ score of 50-55 to \~70 will be part of the study. This IQ score will be provided by the institute's clinical psychologist who examines and score the patient as per American Association of Mental Deficiency (AAMD) criteria.
Microbial Analysis of the Plaque Sample- Under aseptic measures, the buccal surface of the permanent maxillary first molar will be dried with cotton swab and the supragingival plaque sample will be collected on baseline and Day 7 of the intervention prior to mealtime using sterile Gracey curette 1/2 by the principal investigator. Each of the specimen will be transferred into different sterile Eppendorf tubes having in 0.5 ml phosphate-buffered saline (PBS) to prevent cell rupture or shrinkage due to osmosis. The samples will be transported in an Ice Box. This will be cultured on the mitis salivarius agar with bacitracin in Dow Research Institute of Biotechnology and Biomedical Sciences (DRIBBS) by the microbiologist. The plates will be incubated anaerobically at 37◦C for 48 h for growth of S. mutans colonies will then be assessed at the baseline and on Day 7 of the intervention. The S. mutans count will be classified as Class 0 (none), Class 1 (\<102), Class 2 (103-104) and Class 3 (10≥5) CFU/ml showing negligible, low, moderate and high caries susceptibility respectively.
Preparation of Triphala Tooth Wipes- The triphala decoction will be prepared by the principal investigator at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan under the supervision of Pharmacognocist. The three fruits of triphala will be bought in powder form from an ayurvedic drug vendor. A mixture will be made by combining equal proportion of all these three powders in distilled water. This will then be boiled till the volume reduces to 1/8th part of the initial volume.
A sweetener will be added to the decoction followed by filtering using a white muslin cloth and then storing in a sterile amber-coloured glass bottle in a refrigerator. This will preserve its organoleptic properties and its quality for fourteen days.
The decoction obtained will be subjected to dilution to obtain concentration. This will then be used to impregnate the marketed tooth wipes fabric. The triphala tooth wipes will be cut, folded individually, and then packed using the wet wipes machine in a plain white packing by local pharmaceutical company. Each pack will contain 16 wipes.
Preparation of Chlorhexidine Tooth Wipes- The commercially available chlorhexidine mouthwash containing will be purchased from the market and will then be used to impregnate the marketed tooth wipes fabric. The chlorhexidine tooth wipes will be cut, folded individually, and then packed using the wet wipes machine in a plain white packing by local pharmaceutical company. Each pack will contain 16 wipes.
Data Collection:
Consent- Before initiation of the study, informed consent will be taken from the parent and/or guardian.
Proforma- The questionnaire will consist of their demographic details and Intelligence Quotient (IQ) score. The Streptococcus mutans count will be assessed on day 1 and day 7 of the intervention.
IQ Score- Mild ID having IQ score of 50-55 to \~70 will be part of the study. This IQ score will be provided by the institute's clinical psychologist who examines and score the patient as per American Association of Mental Deficiency (AAMD) criteria.
Microbial Analysis of the Plaque Sample- Under aseptic measures, the buccal surface of the permanent maxillary first molar will be dried with cotton swab and the supragingival plaque sample will be collected on baseline and Day 7 of the intervention prior to mealtime using sterile Gracey curette 1/2 by the principal investigator. Each of the specimen will be transferred into different sterile Eppendorf tubes having in 0.5 ml phosphate-buffered saline (PBS) to prevent cell rupture or shrinkage due to osmosis. The samples will be transported in an Ice Box. This will be cultured on the mitis salivarius agar with bacitracin in Dow Research Institute of Biotechnology and Biomedical Sciences (DRIBBS) by the microbiologist. The plates will be incubated anaerobically at 37◦C for 48 h for growth of S. mutans colonies will then be assessed at the baseline and on Day 7 of the intervention. The S. mutans count will be classified as Class 0 (none), Class 1 (\<102), Class 2 (103-104) and Class 3 (10≥5) CFU/ml showing negligible, low, moderate and high caries susceptibility respectively.
Conditions
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Plaque Control
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The participants will be allocated in either of the two treatment arms through Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) by the principal investigator.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
It will be a double-blinded study where the participants and the microbiologist will be unaware of the group allocation.
Study Groups
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Triphala Tooth Wipe
The three fruits of triphala (Terminalia chebula, Emblica officinalis and Terminalia bellerica) will be bought in powder form from an herbal drug vendor. A mixture will be made by combining equal proportion of all these three powders in distilled water. This will then be boiled till the volume reduces to 1/8th part of the initial volume. A sweetener will be added to the decoction followed by filtering using a white muslin cloth and then storing in a sterile amber-coloured glass bottle in a refrigerator. The decoction obtained will be subjected to dilution to obtain 0.6% concentration. This will then be used to impregnate the marketed tooth wipes fabric. The triphala tooth wipes will be cut, folded individually, and then packed. Each pack will contain 16 wipes.
Group Type
EXPERIMENTAL
Triphala Tooth Wipe
Intervention Type
OTHER
The wipes will be used 1 hour after meal time, twice daily for consecutively 7 days. The sachet seal will be opened, the wipe will be taken out and rest of the sachet sealed again. The wipes will be unfolded and wrapped around index finger of right hand and all surfaces of child's teeth, gums, roof of the mouth and tongue will be cleaned.
Chlorhexidine Tooth Wipe
The commercially available mouthwash containing 0.2% chlorhexidine will be purchased from the market and will then be used to impregnate the marketed tooth wipes fabric. The chlorhexidine tooth wipes will be cut, folded individually, and then packed. Each pack will contain 16 wipes.
Group Type
ACTIVE_COMPARATOR
Chlorhexidine Tooth Wipe
Intervention Type
OTHER
Same as triphala tooth wipe
Interventions
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Triphala Tooth Wipe
The wipes will be used 1 hour after meal time, twice daily for consecutively 7 days. The sachet seal will be opened, the wipe will be taken out and rest of the sachet sealed again. The wipes will be unfolded and wrapped around index finger of right hand and all surfaces of child's teeth, gums, roof of the mouth and tongue will be cleaned.
Intervention Type
OTHER
Chlorhexidine Tooth Wipe
Same as triphala tooth wipe
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Participants with informed consent
2. Children with mild intellectual disability as per American Association of Mental Deficiency (AAMD)
3. Age ranging from 6 to 12 years
4. One treatment group will be thirty children receiving triphala tooth wipes
5. The other treatment group will be thirty children receiving chlorhexidine tooth wipes
2. Children with mild intellectual disability as per American Association of Mental Deficiency (AAMD)
3. Age ranging from 6 to 12 years
4. One treatment group will be thirty children receiving triphala tooth wipes
5. The other treatment group will be thirty children receiving chlorhexidine tooth wipes
Exclusion Criteria
1. Children who had received antibiotics within 3 months
2. Participants requiring urgent dental care during the period of study
2. Participants requiring urgent dental care during the period of study
Minimum Eligible Age
6 Years
Maximum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dow University of Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Sana Masood
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Sana Masood, BDS
Role: PRINCIPAL_INVESTIGATOR
Dow University of Health Sciences
Locations
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Dar-ul-Sukun
Karachi, , Pakistan
Site Status
Countries
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Pakistan
References
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Other Identifiers
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IRB-3384/DUHS/Approval/2024/53
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
NCT00966953
COMPLETED
PHASE3
Efficacy of Salivary Bacteria and Post Brushing
NCT00981825
COMPLETED
PHASE3
Evaluation of New Different Herbal Mouthwashes Against Caries Forming Bacteria, RCT
NCT05623605
UNKNOWN
PHASE4
Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection
NCT02221193
COMPLETED
EARLY_PHASE1
To Investigate the Clinical Efficacy of an Experimental Toothpaste
NCT01079910
WITHDRAWN
PHASE1
Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers
NCT07121361
COMPLETED
NA
Anticaries Effect of Xylitol,Probiotic and Chlorhexidine Mouth Rinses Among Individuals at High Risk
NCT04399161
COMPLETED
PHASE2/PHASE3
Title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
NCT05258955
COMPLETED
PHASE1
Compare the Clinical Efficacy of Prototype Toothpastes.
NCT00761930
COMPLETED
PHASE3
Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment
NCT06089564
COMPLETED
NA