NCT05110534

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2.2 years

First QC Date

November 3, 2021

Last Update Submit

November 5, 2021

Conditions

Dental Caries in Children

Keywords

General anaesthesiaChildrenCaries preventionPediatric dentistry

Outcome Measures

Primary Outcomes (3)

  • Approximal Plaque Index (API)

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

    1 year

  • Gingiva Sulcus Bleeding Index (SBI)

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

    1 year

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

    WHO index to assess caries prevalence and caries status

    1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

Received two additional preventive oral hygiene appointments; one week before the general anaesthesia treatment and one week after the general anaesthesia.

Behavioral: additional oral hygiene appointments

Control group

NO INTERVENTION

Received only standard prevention, without two additional preventive oral hygiene appointments before and after the general anaesthesia.

Interventions

additional oral hygiene appointmentsBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • children above 5 years old
  • no parental approval

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Preventive and Pediatric Dentistry, University of Greifswald

Greifswald, D-17457, Germany

Location

Study Officials

  • Mohamad Alkilzy, PD Dr.

    Department of Preventive and Pediatric Dentistry, University of Greifswald

    PRINCIPAL INVESTIGATOR

  • Christian Splieth, Prof. Dr.

    Department of Preventive and Pediatric Dentistry, University of Greifswald

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.The examiners were blinded regarding the group status of the children, as other practice personal had to perform the preventive sessions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 8, 2021

Study Start

October 1, 2017

Primary Completion

December 20, 2019

Study Completion

December 31, 2019

Last Updated

November 8, 2021

Record last verified: 2021-11

Locations

DE(1)