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

NCT ID: NCT02443896

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-08-31

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,

1. The ability to recruit based on failure to meet exclusion criteria, declining to participate or other reasons and retention rates based on subsequent withdrawals.

2. Feasibility and acceptability of placing sealants in this setting, based on compliance with the intervention.

3. Sealant retention rates based on the proportion of sealants that were fully intact, partially intact or lost after 24 months.

4. 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:

1. Experience of caries into dentine in at least one permanent molar

2. Untreated caries into dentine in at least one permanent molar

5. 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.

6. Oral health support provided by referring practitioners, within the 2 years following the dental GA, based on,

1. Structured interview questionnaire to record parents' experience of preventive advice and treatment received, following the GA extractions

2. 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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sealant applied to molars

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.

Group Type: EXPERIMENTAL

Pit and Fissure Sealant of permanent molars

Intervention Type: PROCEDURE

The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard

No sealant applied to molars.

No molars will be sealed.

Group Type: SHAM_COMPARATOR

No sealant of permanent molars

Intervention Type: PROCEDURE

No sealant applied to permanent molars.

Interventions

Pit and Fissure Sealant of permanent molars

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

No sealant of permanent molars

No sealant applied to permanent molars.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Birmingham Community Healthcare NHS

OTHER_GOV

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Dietrich

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

Birmingham Dental Hospital

Birmingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

RG_14-089

Identifier Type: -

Identifier Source: org_study_id