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The impact of home use of dental plaque disclosing agent (chewing tablets) on oral hygiene in high caries risk schoolchildren: A single-blinded randomized controlled clinical trial with 3 months follow-up

The impact of home use of dental plaque disclosing agent (chewing tablets) on oral hygiene in high caries risk schoolchildren: A single-blinded randomized controlled clinical trial with 3 months follow-up

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034971
Enrollment
100
Registered
2024-09-09
Start date
2025-01-02
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K05.1

Interventions

Group 1: Usual motivation and instructions for oral hygiene as part of regular individual prophylaxis (including recommendation of weekly use of fluoride gel) as well as counselling for tooth brushing
additionally weekly use of dental plaque disclosing agent (Plaquefinder, tablets, Curaprox, Switzerland) before the weekly use of fluoride gel

Sponsors

Dep. Pediatric Dentistry
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: - Children aged 6 - 12 years - Caries risk child: "dmft/DMFT > 0“ or „dmft/DMFT = 0 with at least one active initial carious lesion" or "MIH". - Child scheduled for in-office oral examination and individual caries prevention session including disclosure of plaque - Insufficient oral hygiene (visible plaque without disclosing agent) - Willingness to use on a weekly basis highly concentrated fluoride gel & plaque disclosing tablets. - Willing to come for prophylaxis appointment approx. 3 months later. - Signed written informed consent form for study participation.

Exclusion criteria

Exclusion criteria: - Patients with pain or acute oral symptoms to be treated - Patients with systemic diseases that require special attention during their dental treatment - Patients with fixed orthodontic appliances - Patients who are already using a plaque disclosing agents at home on a regular basis - Caregiver/ children who refuse to participate in the study - Allergy against ingredients of disclosing agent

Design outcomes

Primary

MeasureTime frame
Oral hygiene status will be assessed by blinded examiner using modified Quigley-Hein Plaque Index (mQHI) and gingival health status Index (PBI) at baseline and in 3-months follow-up.—

Secondary

MeasureTime frame
Patient / caregiver satisfaction, acceptance and perceptions of the prevention program (use of plaque disclosing agent at home) using e.g. a questionnaire with five-point Likert Scale.—

Countries

Germany

Contacts

Public ContactRouwan Mohamed

Dep. of Pediatric Dentistry

rouwan.mohamed@stud.uni-greifswald.de+49 3834 867136

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026