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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Updated: Jun 25, 2025

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A Cluster Randomised Controlled Trial of a Targeted Distributed Toothpaste and Toothbrushing Programme.

Michaela Goodwin1, Laura MacKay1, Tanya Walsh1

  • 1Division of Dentistry, Faculty of Biology, Medicine and Health, The University of Manchester, M15 6SE, Manchester, UK.

Caries Research
|May 23, 2024
PubMed
Summary
This summary is machine-generated.

A targeted toothbrush and toothpaste program did not significantly reduce tooth extraction referrals under Dental General Anaesthesia (DGA) for high-risk children. This dental intervention showed no clinically meaningful difference compared to usual care for these families.

Keywords:
CariesChild DentistryDental public healthFluoridesInequalitiesPediatric Dentistry

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Area of Science:

  • Public Health Dentistry
  • Pediatric Oral Health
  • Health Intervention Research

Background:

  • High rates of tooth decay necessitate interventions for at-risk children.
  • Dental General Anaesthesia (DGA) for tooth extraction is a significant concern in pediatric care.
  • Targeted oral hygiene programs aim to reduce the need for invasive dental procedures.

Purpose of the Study:

  • To evaluate the effectiveness of a distributed, targeted toothbrush and toothpaste program.
  • To assess the impact on referrals for tooth extraction under Dental General Anaesthesia (DGA).
  • To compare the intervention against usual care in high-risk families.

Main Methods:

  • A blinded, clustered parallel randomized controlled trial (RCT) involving families with children aged 3-10 years.
  • Participants were recruited from hospitals in North West England.
  • The primary outcome measured was referral for DGA 6-24 months post-randomization.

Main Results:

  • 961 families (1,671 children) were randomized; 1,662 children were included in the final analysis.
  • 9.2% of the intervention group and 6.8% of the control group were referred for DGA within 2 years.
  • No clinically meaningful difference in DGA referrals was found between the intervention and usual care groups (RR 1.36, 95% CI: 0.98-1.89).

Conclusions:

  • The intervention's focus on families with children undergoing DGA was appropriate.
  • The study highlights the need for policymakers to understand repeat DGA occurrences.
  • Further interventions may be required to address recurrent dental issues in high-risk pediatric populations.