Dental CariesNCT02443896
The Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions
A study testing Pit and Fissure Sealant of permanent molars and No sealant of permanent molars in people with Dental Caries, run by University of Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Pit and Fissure Sealant of permanent molars and No sealant of permanent molars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Pit and Fissure Sealant of permanent molars, No sealant of permanent molars
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pit and Fissure Sealant of permanent molarsProcedure or surgery
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 of permanent molarsProcedure or surgery
No sealant applied to permanent molars.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pit and Fissure Sealant of permanent molars |
| No sealant applied to molars. | Sham comparator | No molars will be sealed. Receives: Procedure: No sealant of permanent molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries incidence
The incidence of dental caries in permanent molars will be recorded.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2014
- Primary completionMay 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham Community Healthcare NHS
- Responsible party
- Sponsor
- Investigators
- Thomas Dietrich, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443896
- Sponsor's protocol ID
- RG_14-089
- Status last verified
- Jan 2017
- First submitted
- 1 Apr 2015
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02443896
- Acronym / sponsor ID
- RG_14-089
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Birmingham Community Healthcare NHS
- Study start
- Apr 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sealant applied to molars | Experimental | Procedure: Pit and Fissure Sealant of permanent molarsAll '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 sealant applied to molars. | Sham comparator | Procedure: No sealant of permanent molarsNo molars will be sealed. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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'
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pit and Fissure Sealant of permanent molarsThe tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard | Procedure or surgery | Sealant applied to molars |
| No sealant of permanent molarsNo sealant applied to permanent molars. | Procedure or surgery | No sealant applied to molars. |
Primary outcome
Caries incidence
Time frame: 12 months
The incidence of dental caries in permanent molars will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Dietrich principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pit and Fissure Sealant of permanent molars and No sealant of permanent molars in people with Dental Caries, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries incidence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.