Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies

NCT06575335 | Completed

• 1 other identifier: IRB-3384/DUHS/Approval/2024/53
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Control

Keywords

differently abled; triphala; chlorhexidine; tooth wipes

Outcome Measures

Primary Outcomes (1)

• Streptococcus mutans (S. mutans) count

  Colony Forming Unit per millilitre (CFU/ml) 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

  The S. mutans count will be assessed at baseline and at day 8 of the intervention.

Secondary Outcomes (1)

• Plaque Index

  These counts will be assessed at baseline and at day 8 of the intervention.

Study Arms (2)

Triphala Tooth Wipe

EXPERIMENTAL

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.

Other: Triphala Tooth Wipe

Chlorhexidine Tooth Wipe

ACTIVE COMPARATOR

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.

Other: Chlorhexidine Tooth Wipe

Interventions

Triphala Tooth Wipe 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.

Triphala Tooth Wipe

Chlorhexidine Tooth Wipe OTHER

Same as triphala tooth wipe

Chlorhexidine Tooth Wipe

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants with informed consent
• Children with mild intellectual disability as per American Association of Mental Deficiency (AAMD)
• Age ranging from 6 to 12 years
• One treatment group will be thirty children receiving triphala tooth wipes
• The other treatment group will be thirty children receiving chlorhexidine tooth wipes

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dar-ul-Sukun

Karachi, Pakistan

Location

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Study Officials

• Sana Masood, BDS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: It will be a double-blinded study where the participants and the microbiologist will be unaware of the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The participants will be allocated in either of the two treatment arms through Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) by the principal investigator.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 28, 2024
• Study Start: September 30, 2024
• Primary Completion: October 7, 2024
• Study Completion: November 7, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)