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The Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pit and Fissure Sealant of permanent molars
No sealant of permanent molars
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Children that are to have extraction of at least one carious tooth under a chair General Anaesthetic at Birmingham Dental Hospital
  • Birmingham residents (as indicated by post code of home address)
  • Be aged 5 to 15 years
  • Be co-operative to a clinical dental examination
  • Present with at least one permanent molar tooth that is 'sound and sealable'
  • Be accompanied by an adult that has legal capacity to give informed consent

Exclusion criteria

Patients who at the pre-General Anaesthetic assessment visit present with:

  • Signs of a systemic illness (e.g. coughs, 'colds', chicken pox) that might preclude placement of sealants
  • Oral symptoms (e.g. pain, swelling) that would preclude sealant placement
  • Parents unable to confirm (with a reasonable degree of certainty) that they would be contactable and able to attend for review during the 2 years duration of the study (e.g. because of plans to move)

Sites / Locations

  • Birmingham Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Sealant applied to molars

No sealant applied to molars.

Arm Description

All 'sealable' permanent molars will be sealed: Occlusal fissures and where appropriate, buccal pits (on lower molars) and palatal pits (on upper molars) will be sealed. If patient compliance is adequate, a resin based sealant will be used as the first choice material. The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard.

No molars will be sealed.

Outcomes

Primary Outcome Measures

Caries incidence
The incidence of dental caries in permanent molars will be recorded.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2015
Last Updated
December 21, 2021
Sponsor
University of Birmingham
Collaborators
Birmingham Community Healthcare NHS
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1. Study Identification

Unique Protocol Identification Number
NCT02443896
Brief Title
The Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions
Official Title
A Pilot Study to Investigate the Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions Under a Chair General Anaesthetic
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
Birmingham Community Healthcare NHS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of thus study is to assess the feasibility and inform the planning of a proposed definitive randomised controlled clinical trial to investigate the efficacy of sealing permanent molars in children requiring caries related extractions under a chair General Anaesthetic.
Detailed Description
Objective: To evaluate, The ability to recruit based on failure to meet exclusion criteria, declining to participate or other reasons and retention rates based on subsequent withdrawals. Feasibility and acceptability of placing sealants in this setting, based on compliance with the intervention. Sealant retention rates based on the proportion of sealants that were fully intact, partially intact or lost after 24 months. Two-year incidence of caries in permanent molars that were sound and suitable for sealants at the time of the pre-GA assessment, based on the proportion of children with: Experience of caries into dentine in at least one permanent molar Untreated caries into dentine in at least one permanent molar Oral health related Quality of Life (OHRQoL) two years following caries related extractions under GA, based on the Child-Oral Impacts on Daily Performances (Child-OIDP) scale and separate questions relating to specified oral symptoms. Oral health support provided by referring practitioners, within the 2 years following the dental GA, based on, Structured interview questionnaire to record parents' experience of preventive advice and treatment received, following the GA extractions Sealants identified at follow up that were not present at baseline or provided as part of the study Recruitment and randomisation: Recruitment was carried out over a total period of 8 months. However, during this time, the study investigator (AR) was only available to recruit participants on ad hoc dates. Therefore, to facilitate recruitment, referral letters were triaged to identify children that were likely to be eligible (based on age, postcode and reason for GA referral) so they could be scheduled on these dates. Study information (including separate leaflets for parents and children) was posted a few weeks before the GA assessment appointment. At this visit, clinicians responsible for completing the GA assessment, also screened children to identify those that had potentially sealable permanent molars, and they were then invited to see the investigator on the same day. Further to this, eligibility to take part in the study, based on the full list of inclusion criteria was confirmed following full verbal and written consent. Results: Although the recruitment period extended over 8 months, as explained earlier, the study investigator was only available to undertake enrolment on a limited number of ad hoc sessions throughout this time. Based on these, 132 children were assessed for eligibility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sealant applied to molars
Arm Type
Experimental
Arm Description
All 'sealable' permanent molars will be sealed: Occlusal fissures and where appropriate, buccal pits (on lower molars) and palatal pits (on upper molars) will be sealed. If patient compliance is adequate, a resin based sealant will be used as the first choice material. The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard.
Arm Title
No sealant applied to molars.
Arm Type
Sham Comparator
Arm Description
No molars will be sealed.
Intervention Type
Procedure
Intervention Name(s)
Pit and Fissure Sealant of permanent molars
Intervention Description
The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard
Intervention Type
Procedure
Intervention Name(s)
No sealant of permanent molars
Intervention Description
No sealant applied to permanent molars.
Primary Outcome Measure Information:
Title
Caries incidence
Description
The incidence of dental caries in permanent molars will be recorded.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Children that are to have extraction of at least one carious tooth under a chair General Anaesthetic at Birmingham Dental Hospital Birmingham residents (as indicated by post code of home address) Be aged 5 to 15 years Be co-operative to a clinical dental examination Present with at least one permanent molar tooth that is 'sound and sealable' Be accompanied by an adult that has legal capacity to give informed consent Exclusion criteria Patients who at the pre-General Anaesthetic assessment visit present with: Signs of a systemic illness (e.g. coughs, 'colds', chicken pox) that might preclude placement of sealants Oral symptoms (e.g. pain, swelling) that would preclude sealant placement Parents unable to confirm (with a reasonable degree of certainty) that they would be contactable and able to attend for review during the 2 years duration of the study (e.g. because of plans to move)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Dietrich
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Dental Hospital
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

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The Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions

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