The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars (ResinFS)

November 6, 2024 updated by: Rona Leith, University of Dublin, Trinity College

The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars: a 2-year Randomised Clinical Trial

Background: Resin-based fissure sealants (FS) are recommended to prevent pit-and-fissure caries development or prevent the progression of enamel caries lesion to frank cavitation into dentine. There is still limited clinical evidence on the use of adhesive system beneath fissure sealants in permanent molars and its effect on FS retention and caries progression.

Aim: The aim of this randomised clinical trial is to evaluate the clinical efficacy of fissure sealants placed with and without prior use of an adhesive system in terms of retention and caries prevention in permanent molars over the period of 2 years.

Study design: Children (6-12 years of age) with high caries risk that require sealants in their first permanent molars (ICDAS 0-3) will be selected at the Dublin Dental University Hospital (DDUH). Molars will be stratified according to presence of caries lesions (ICDAS 0 or ICDAS1-3) and randomly allocated according to the study groups (Test group: 17% phosphoric acid + adhesive system + FS; Control group: 17% phosphoric acid + FS). The randomisation unit will be the tooth and more than one tooth can be included per child. All children will be evaluated after 12 and 24 months by calibrated independent examiners. The primary outcome of the present trial is sealant retention over time. Clinical variables such as age, gender, tooth position (upper/lower), caries experience (DMFT/dmft), stage of eruption (erupted/partially erupted) and children's behavior (Frankl scale) will be collected.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction

Resin-based fissure sealants (FS) have been used as a physical barrier in pit-and-fissures with the aim to reduce biofilm accumulation and prevent the development of new caries lesions in first permanent molars. Several international guidelines recommend the use of FS for caries prevention in the paediatric population.

The majority of the FS manufactures recommend the etching of the enamel surface prior to FS application in order to remove any remaining plaque debris and to increase the surface contact area by superficial demineralisation of tooth surface. Resin based-fissure sealants contain light-activated urethane dimethacrylate (UDMA) or bisphenol A-glycidyl methacrylate (Bis-GMA) resin in its composition which bonds to the etched enamel. Several clinical studies have investigated the use of an intermediate layer of adhesive system (primer and bond) in order to increase the bonding strength and increase retention of FS over time in caries free molars, however little is known on the effect on caries progression and the choice of FS protocol for treatment of enamel caries lesions.

Another factor that can influence the performance of resin-based fissure sealant due to hydrophobic characteristics of the material is the presence of saliva contamination (poor moisture control) during application. Therefore, the stage of eruption, patient's behaviour and operator experience can play a major role when it comes to FS retention on tooth surfaces. The majority of clinical trials in the field had trained and experienced operators, including specialists in paediatric dentistry, which could impact the translational and external validity of their findings. More studies are needed with less experienced operators in order to evaluate the effectiveness of FS placement in different environments.

Therefore, the aim of the present randomised clinical trial is to evaluate the effectiveness of resin-based fissure sealant placed by undergraduate dental students with or without an intermediate layer of adhesive system in terms of dentine caries prevention and retention over time.

Methods

Study Design The present study is a two-parallel arm, controlled, single-blind clinical trial. This study will be registered at Clinical Trials website and submitted to approval by the local Ethics Committee (SJH/AMNCH Joint Research Ethics Committee).

Sample Size Calculation For the sample size calculation, we have considered the results of a previous study from McCafferty & O'Connell 2016 (difference of sealant retention between the groups of 13%; bonded 92% and non-bonded 79%). The sample size calculation was performed using https://www.sealedenvelope.com/ website using a significance level of 5% (alpha) and a power of 80% (1-beta). A minimum sample of 112 teeth per group was required. We increased the sample size by 40% to compensate the cluster effect (more than one tooth can be included per child) and possible loss to follow-up. The final sample required is 313 teeth.

Randomisation process The randomisation unit is the tooth and more than one tooth can be included per child. The website https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used for randomisation list generation, using blocks of different sizes (4, 6 and 8). Sealed, sequentially numbered, opaque envelopes will be used and opened at the time of sealant placement.

Operators All sealants will be placed by undergraduate dental students during the undergraduate clinic in Paediatric Dentistry. The treatment will be supervised by an experienced dentist/clinical supervisor.

Interventions

Control group (FS)

  1. Cotton roll isolation: cotton roll will be placed buccally and lingually/palatally to the first permanent molar to be treated. A saliva ejector will be used to remove any excess of saliva. If the cotton roll are saturared in saliva at any point of the treatment, they will need to be changed.
  2. Etching of the enamel surface: 17% phosphoric acid will be applied for 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO) using the etch syringe applicator tip.
  3. Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface. A high volume suction will be used. Cotton pellets will be changed to a dry ones at this stage and the surface will be dried for 5s using the air syringe.
  4. Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip. A probe will be used to ensure that the material is present in all fissures without any air bubbles.
  5. Lightcuring: The material will be lightcured for 20 seconds. The material colour will change to an opaque off white colour when exposed to light.
  6. Check occlusion: After checking for premature contact points, if there is a need to remove a excess of material, a superfine diamond bur or a silicone finishing point can be used for adjustments.

Test group (Adhesive + FS)

  1. Cotton roll isolation: cotton roll will be placed buccally and lingually/palatally to the first permanent molar to be treated. A saliva ejector will be used to remove any excess of saliva. If the cotton roll are saturared in saliva at any point of the treatment, they will need to be changed.
  2. Etching of the enamel surface: 17% phosphoric acid will be applied for 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO) using the etch syringe applicator tip.
  3. Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface. A high volume suction will be used. Cotton pellets will be changed to a dry ones at this stage and the surface will be dried for 5s using the air syringe.
  4. Adhesive system application: the adhesive system (Futurabond, VOCO) single dose capsule will be applied over the surface to be sealed for 5 seconds using a microbrush (ative movements along the fissures to ensure bond penetration). The bond will be air thin dried for removal of solvent and excess material. The bond will be lightcured for 10s before sealant placement.
  5. Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip. A probe will be used to ensure that the material is present in all fissures without any air bubbles.
  6. Lightcuring: The material will be lightcured for 20 seconds. The material colour will change to an opaque off white colour when exposed to light.
  7. Check occlusion: After checking for premature contact points, if there is a need to remove a excess of material, a superfine diamond bur or a silicone finishing point can be used for adjustments.

Clinical variables such as children's age and gender, tooth position (upper/lower), caries experience (DMFT/dmft), ICDAS score tooth surface (1/2/3), and children's behavior during the procedure (Frankl scale) will be collected.

Evaluations

All children will be evaluated after 12 and 24 months by independent calibrated and blind examiners for both primary (sealant retention) and secondary outcomes.

The presence of dental caries lesion will evaluated according to ICDAS criteria and caries progression into dentine will be recorded. Sealant retention will be evaluated according to the scoring system proposed by Oba et al. 2009: 0 (fully retained sealant); 1 (partially retained sealant) or 2 (absent sealant).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ireland
      • Dublin, Ireland, D02 F859
        • Recruiting
        • Dublin Dental University Hospital - Trintiy College Dublin
        • Contact:
        • Contact:
          • Rona Leith

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. 6 to 12 years of age;
  2. Referred for dental treatment at the Dublin Dental University Hospital DDUH) or that are ongoing patients of the Paediatric dentistry clinic;
  3. With first permanent molars that are caries free or present caries lesions restricted to enamel (ICDAS 1 to 3) indicated for glass ionomer sealants.
  4. Whose parents agreed and consent to participate in the present research;

Exclusion criteria:

  1. Presence of any developmental defects
  2. Presence of any type of restorative/sealant material in the selected tooth;
  3. Presence of a dentine shadow (ICDAS 4) or dentine cavitation (ICDAS 5/6) detected clinically and/or radiographically14;
  4. Insufficient cooperation to achieve adequate moisture control using cotton roll isolation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fissure sealant without adhesive system (NO BOND)
Teeth randomised to the control group will be using issure sealant without adhesive system (NO BOND)
Procedure: Fissure sealant without adhesive system (NO BOND)
  1. Cotton roll isolation
  2. Etching of the enamel surface: 17% phosphoric 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO)
  3. Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface.
  4. Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip.
  5. Lightcuring: The material will be lightcured for 20 seconds.
Experimental: Fissure sealant with adhesive system (BOND)
Teeth randomised to the test group will be treated using fissure sealant with adhesive system (BOND)
Procedure: Fissure sealant with adhesive system (BOND)
  1. Cotton roll isolation
  2. Etching of the enamel surface: 17% phosphoric 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO)
  3. Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface.
  4. Adhesive system application: the adhesive system (Futurabond, VOCO) single dose capsule will be applied over the surface to be sealed for 5 seconds using a microbrush. The adhesive system will be air thin dried and lightcured for 10s before sealant placement.
  5. Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip.
  6. Lightcuring: The material will be lightcured for 20 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sealant Retention
Time Frame: Sealant retention will be evaluated after 1 and 2 years.

Sealant retention will be examined after 1 and 2 years by a trained, calibrated, independent examiner. Sealant retention (secondary outcome) will be evaluated according to the scoring system proposed by Oba et al. 2009: 0 (fully retained sealant); 1 (partially retained sealant) or 2 (absent sealant).

Early failures will be identified and recorded in the patient's review appointment in the undergraduate clinic.
Sealant retention will be evaluated after 1 and 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient behaviour
Time Frame: Immediately after the procedure
Patient's behaviour during the treatment will be reported by the operator at the end of the procedure using Frankl's behavior rating scale.
Immediately after the procedure
Caries Progression
Time Frame: Caries Progression will be evaluated after 1 and 2 years
Caries progression will be examined after 1 and 2 years by a trained, calibrated, independent examiner according to ICDAS criteria (Ismail et al., 2006). Presence of caries progression will be scored if progression into dentine is seen (ICDAS 4-6).
Caries Progression will be evaluated after 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dublin, Trinity College

Investigators

  • Principal Investigator: Rona Leith, DDUH - Trinity College Dublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Estimated)

June 5, 2025

Study Completion (Estimated)

June 5, 2027

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231104_ResinFS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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