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Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies

NCT06575335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-17

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

Chlorhexidine Tooth Wipe

Same as triphala tooth wipe

Sponsors & Collaborators

  • Dow University of Health Sciences

    lead OTHER

Principal Investigators

  • Sana Masood, BDS · Dow University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2024-10-07
Completion
2024-11-07

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575335 on ClinicalTrials.gov