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

NCT02443896 | Completed

• 1 other identifier: RG_14-089
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Caries incidence

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

  12 months

Study Arms (2)

Sealant applied to molars

EXPERIMENTAL

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.

Procedure: Pit and Fissure Sealant of permanent molars

No sealant applied to molars.

SHAM COMPARATOR

No molars will be sealed.

Procedure: No sealant of permanent molars

Interventions

Pit and Fissure Sealant of permanent molars PROCEDURE

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

Sealant applied to molars

No sealant of permanent molars PROCEDURE

No sealant applied to permanent molars.

No sealant applied to molars.

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Birmingham: lead
• Birmingham Community Healthcare NHS: collaborator

Study Sites (1)

Birmingham Dental Hospital

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Thomas Dietrich

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: May 14, 2015
• Study Start: April 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2018
• Last Updated: January 11, 2022

Record last verified: 2017-01

Locations

GB (1)