Clinical trial NCT06575335: Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies
Official title: Antibacterial Efficacy of Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies in Differently Abled Children- A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Control
Keywords: differently abled
triphala
chlorhexidine
tooth wipes
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be allocated in either of the two treatment arms through Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) by the principal investigator.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

1. Children who had received antibiotics within 3 months
2. Participants requiring urgent dental care during the period of study

Primary outcomes:
measure: Streptococcus mutans (S. mutans) count
timeFrame: The S. mutans count will be assessed at baseline and at day 8 of the intervention.
Secondary outcomes:
measure: Plaque Index
timeFrame: These counts will be assessed at baseline and at day 8 of the intervention.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dar-ul-Sukun
Study officials:
affiliation: Dow University of Health Sciences
name: Sana Masood, BDS
role: PRINCIPAL_INVESTIGATOR
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