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NCT Number: NCT05110534

Supportive Caries Preventive Programme in Children Undergoing Dental General Anaesthesia

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.

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Preventive and Pediatric Dentistry, University of Greifswald

Greifswald, D-17457, Germany

About this study

Early Childhood Caries (ECC) is considered to be a global problem, as it is one of the most prevalent diseases in childhood. This leads to a severe problem in the caries risk children being highly affected by ECC, mostly also non-cooperative and from lower socio-economic background. The dental treatment for these pre-school children often requires general anaesthesia (GA), which is associated with health risks and considerable costs.

Thus, this study was to investigate the preventive effect of two additional intensive oral hygiene appointments before and after general anaesthesia.

After approval by the Ethics Committee at the University of Greifswald (No. BB 078/17), children with an age range from 2 to 5 years assigned for dental treatment under general anaesthesia were recruited.

After obtaining informed consent from the parents, the participants were randomly allocated to the test and control groups by a computer-generated random sequence prepared by a statistician, blinded to the recruiting person. Both groups received a baseline examination and the standard preventive program offered within the German National Health System consisting of explaining the etiology of caries and preventive approaches such as practical training of the parents in tooth brushing in their child as well as recommending fluoridated toothpaste and a reduction of cariogenic snacks. Finally fluoride varnish was applied. The test group received two additional preventive sessions including oral hygiene instructions using plaque disclosing agent, toothbrushing and fluoride application, one week before the date of the general anaesthesia treatment and at the control visit about a week after the general anaesthesia.

The baseline and follow-up examinations at 6 and 12 months recorded caries, fillings and missing teeth due to caries according to the World Health Organisation (WHO) criteria and it included initial caries lesions according to International Caries Detection and Assessment System (ICDAS 1-3). The subcomponents were also added up as initial, decayed, missing, filled, teeth/surfaces (idmft/idmfs). Due to the young age of the children, only primary teeth were of relevance.

In addition, the Approximal Plaque Index (API) and the gingiva Sulcus Bleeding Index (SBI) were taken. The examiners were blinded regarding the group status of the children, as other practice personal had to perform the preventive sessions.

Sample size calculation and statistical analyses:

The expected difference in new caries lesions between test and control groups was taken as an outcome parameter for sample size calculation. Previous regional studies had shown a mean caries development of 2 +-1.5 per year after the general anaesthesia. An intensive prevention program may result in a caries reduction of 30%, corresponding to 0.5-0.6 dmft less in the test group. With α being 0.05 and a power β of 0.80, 142 children were needed in each group, with a drop-out of 30% (62 children) this would mean a total sample size of 408 children at baseline.

The collected data were entered in Excel (Microsoft, USA), then transferred to Stata (Version 14.2; Stata Corp, College Station, USA) for further statistical analysis. Due to the large sample size and the randomization matching or data linkage analysis were not required, but a drop-out analysis was carried out to exclude a bias caused by attrition within the study. A modelling of continuous variables was carried out using restricted cubic splines. Mixed models were used for adjusting the analyses of changes within every group between baseline and recalls and between the two groups. Linear models were used for calculating the absolute effect and ordinal logistic regression for calculating the relative effect via odds ratios.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 2-5 years old children attending dental treatment under general anaesthesia
  • parental approval

Exclusion criteria

  • children above 5 years old
  • no parental approval

Treatment and study plan

additional oral hygiene appointments

Behavioral

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.

Primary outcomes

  1. Approximal Plaque Index (API)

    Time frame: 1 year

    an index to assess oral health by calculating the accumulated dental plaque on teeth surfaces

  2. Gingiva Sulcus Bleeding Index (SBI)

    Time frame: 1 year

    an index to assess oral health by calculating the inflammation and bleeding of the gingiva sulcus

  3. Caries and Initial Caries Index: decayed, missing, filled teeth (idmft)

    Time frame: 1 year

    WHO index to assess caries prevalence and caries status

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Gemeinsamer Bundesaussschuss

Registry information

Official study title

Randomized Controlled Trial on an Supportive Caries Preventive Programme in Children Undergoing Dental General Anaesthesia

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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