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Supportive Caries Preventive Programme in Children Undergoing Dental General Anaesthesia

NCT05110534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2021-11-08

No results posted yet for this study

Summary

Early childhood caries is a persistent problem often leading to dental treatment under general anaesthesia (GA). Thus, this study was to investigate the preventive effect of two additional intensive oral hygiene appointments before and after general anaesthesia.

In this randomized, controlled clinical trial, 408 children (age 2-5 years, mean 4.2+-1.04) intended for general anaesthesia were recruited and randomly assigned to the intervention and control groups with or without two additional intensive oral hygiene appointments before and after the general anaesthesia. At baseline and at 6-/12-month follow-ups, Approximal Plaque Index (API), gingiva Sulcus Bleeding Index (SBI), caries and initial caries index: initial, decayed, missing, filled, teeth (idmft) were recorded.

Conditions

  • Dental Caries in Children

Interventions

BEHAVIORAL

additional oral hygiene appointments

Two additional preventive sessions including oral hygiene instructions one week before the date of the general anaesthesia treatment and at the control visit about a week after the general anaesthesia.

Sponsors & Collaborators

  • Innovationsausschuss beim Gemeinsamen Bundesausschuss, (Innovationsfund) Germany

    collaborator UNKNOWN

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Mohamad Alkilzy, PD Dr. · Department of Preventive and Pediatric Dentistry, University of Greifswald

  • Christian Splieth, Prof. Dr. · Department of Preventive and Pediatric Dentistry, University of Greifswald

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-12-20
Completion
2019-12-31

Countries

  • Germany

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 NCT05110534 on ClinicalTrials.gov