Dental CariesResinFSNCT06608563
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
A study testing Fissure sealant without adhesive system (NO BOND) and Fissure sealant with adhesive system (BOND) in people with Dental Caries and Fissure Sealant, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Fissure Sealant
- What is being tested?
- Fissure sealant without adhesive system (NO BOND) and Fissure sealant with adhesive system (BOND)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 5 Jun 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 to 12 years of age;
- Referred for dental treatment at the Dublin Dental University Hospital DDUH) or that are ongoing patients of the Paediatric dentistry clinic;
- With first permanent molars that are caries free or present caries lesions restricted to enamel (ICDAS 1 to 3) indicated for glass ionomer sealants.
- Whose parents agreed and consent to participate in the present research;
Who cannot join
- Presence of any developmental defects
- Presence of any type of restorative/sealant material in the selected tooth;
- Presence of a dentine shadow (ICDAS 4) or dentine cavitation (ICDAS 5/6) detected clinically and/or radiographically14;
- Insufficient cooperation to achieve adequate moisture control using cotton roll isolation
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Dublin Dental University Hospital - Trintiy College Dublin
Dublin, Dublin, D02 F859
About this study
Official title: 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.
Read the 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)
- 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.
- 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.
- 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.
- 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.
- Lightcuring: The material will be lightcured for 20 seconds. The material colour will change to an opaque off white colour when exposed to light.
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.
- Lightcuring: The material will be lightcured for 20 seconds. The material colour will change to an opaque off white colour when exposed to light.
- 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).
- Conditions
- Dental Caries, Fissure Sealant
- Being tested
- Fissure sealant without adhesive system (NO BOND), Fissure sealant with adhesive system (BOND)
- Keywords
- fissure sealant, first permanent molar, retention, adhesive system, children, clinical trial, caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fissure sealant without adhesive system (NO BOND)Procedure or surgery
- Cotton roll isolation
- Etching of the enamel surface: 17% phosphoric 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO)
- Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface.
- Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip.
- Lightcuring: The material will be lightcured for 20 seconds.
Fissure sealant with adhesive system (BOND)Procedure or surgery
- Cotton roll isolation
- Etching of the enamel surface: 17% phosphoric 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO)
- Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface.
- 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.
- Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip.
- Lightcuring: The material will be lightcured for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Fissure sealant without adhesive system (NO BOND) | Active comparator | Teeth randomised to the control group will be using issure sealant without adhesive system (NO BOND) Receives: Procedure: Fissure sealant without adhesive system (NO BOND) |
| Fissure sealant with adhesive system (BOND) | Experimental | Teeth randomised to the test group will be treated using fissure sealant with adhesive system (BOND) Receives: Procedure: Fissure sealant with adhesive system (BOND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant Retention
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.
Measured: Sealant retention will be evaluated after 1 and 2 years.
Secondary outcomes (2)
Caries Progression
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).
Measured: Caries Progression will be evaluated after 1 and 2 years
Patient behaviour
Patient's behaviour during the treatment will be reported by the operator at the end of the procedure using Frankl's behavior rating scale.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start5 Jun 2024
- Primary completion5 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Model description
- Double-blind 2-arm parallel controlled randomised clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rona Leith, University of Dublin, Trinity College
- Investigators
- Rona Leith, Principal investigator, DDUH - Trinity College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608563
- Sponsor's protocol ID
- 231104_ResinFS
- Acronym
- ResinFS
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Memarpour M, Shafiei F, Zarean M, Razmjoei F. Sealing effectiveness of fissure sealant bonded with universal adhesive systems on saliva-contaminated and noncontaminated enamel. J Clin Exp Dent. 2018 Jan 1;10(1):e1-e6. doi: 10.4317/jced.54471. eCollection 2018 Jan.
PubMed 29670708Nazar H, Mascarenhas AK, Al-Mutwa S, Ariga J, Soparker P. Effectiveness of fissure sealant retention and caries prevention with and without primer and bond. Med Princ Pract. 2013;22(1):12-7. doi: 10.1159/000341155. Epub 2012 Aug 9.
PubMed 22889920McCafferty J, O'Connell AC. A randomised clinical trial on the use of intermediate bonding on the retention of fissure sealants in children. Int J Paediatr Dent. 2016 Mar;26(2):110-5. doi: 10.1111/ipd.12165. Epub 2015 Apr 10.
PubMed 25864681Wright JT, Crall JJ, Fontana M, Gillette EJ, Novy BB, Dhar V, Donly K, Hewlett ER, Quinonez RB, Chaffin J, Crespin M, Iafolla T, Siegal MD, Tampi MP, Graham L, Estrich C, Carrasco-Labra A. Evidence-based clinical practice guideline for the use of pit-and-fissure sealants: A report of the American Dental Association and the American Academy of Pediatric Dentistry. J Am Dent Assoc. 2016 Aug;147(8):672-682.e12. doi: 10.1016/j.adaj.2016.06.001.
PubMed 27470525San Martin-Galindo L, Rodriguez-Lozano FJ, Abalos-Labruzzi C, Niederman R. European Fissure Sealant Guidelines: assessment using AGREE II. Int J Dent Hyg. 2017 Feb;15(1):37-45. doi: 10.1111/idh.12174. Epub 2015 Sep 11.
PubMed 26359655Welbury R, Raadal M, Lygidakis NA; European Academy of Paediatric Dentistry. EAPD guidelines for the use of pit and fissure sealants. Eur J Paediatr Dent. 2004 Sep;5(3):179-84. No abstract available.
PubMed 15471528Innes NP, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona A, Schwendicke F. Managing Carious Lesions: Consensus Recommendations on Terminology. Adv Dent Res. 2016 May;28(2):49-57. doi: 10.1177/0022034516639276.
PubMed 27099357van Loveren C, van Palenstein Helderman W. EAPD interim seminar and workshop in Brussels May 9 2015 : Non-invasive caries treatment. Eur Arch Paediatr Dent. 2016 Feb;17(1):33-44. doi: 10.1007/s40368-015-0219-3. Epub 2016 Feb 10.
PubMed 26860292Schwendicke F, Splieth C, Breschi L, Banerjee A, Fontana M, Paris S, Burrow MF, Crombie F, Page LF, Gaton-Hernandez P, Giacaman R, Gugnani N, Hickel R, Jordan RA, Leal S, Lo E, Tassery H, Thomson WM, Manton DJ. When to intervene in the caries process? An expert Delphi consensus statement. Clin Oral Investig. 2019 Oct;23(10):3691-3703. doi: 10.1007/s00784-019-03058-w. Epub 2019 Aug 23.
PubMed 31444695Urquhart O, Tampi MP, Pilcher L, Slayton RL, Araujo MWB, Fontana M, Guzman-Armstrong S, Nascimento MM, Novy BB, Tinanoff N, Weyant RJ, Wolff MS, Young DA, Zero DT, Brignardello-Petersen R, Banfield L, Parikh A, Joshi G, Carrasco-Labra A. Nonrestorative Treatments for Caries: Systematic Review and Network Meta-analysis. J Dent Res. 2019 Jan;98(1):14-26. doi: 10.1177/0022034518800014. Epub 2018 Oct 5.
PubMed 30290130Splieth CH, Ekstrand KR, Alkilzy M, Clarkson J, Meyer-Lueckel H, Martignon S, Paris S, Pitts NB, Ricketts DN, van Loveren C. Sealants in dentistry: outcomes of the ORCA Saturday Afternoon Symposium 2007. Caries Res. 2010;44(1):3-13. doi: 10.1159/000271591. Epub 2009 Dec 31.
PubMed 20068302Beiruti N, Frencken JE, van't Hof MA, Taifour D, van Palenstein Helderman WH. Caries-preventive effect of a one-time application of composite resin and glass ionomer sealants after 5 years. Caries Res. 2006;40(1):52-9. doi: 10.1159/000088907.
PubMed 16352882Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963Oba AA, Dulgergil T, Sonmez IS, Dogan S. Comparison of caries prevention with glass ionomer and composite resin fissure sealants. J Formos Med Assoc. 2009 Nov;108(11):844-8. doi: 10.1016/S0929-6646(09)60415-0.
PubMed 19933027
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars: a 2-year Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06608563
- Acronym / sponsor ID
- ResinFS / 231104_ResinFS
- Conditions
- Dental Caries, Fissure Sealant
- Keywords
- fissure sealant, first permanent molar, retention, adhesive system, children, clinical trial, caries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 5 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- 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.
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.
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)
- 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.
- 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.
- 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.
- 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.
- Lightcuring: The material will be lightcured for 20 seconds. The material colour will change to an opaque off white colour when exposed to light.
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.
- Lightcuring: The material will be lightcured for 20 seconds. The material colour will change to an opaque off white colour when exposed to light.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind 2-arm parallel controlled randomised clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Fissure sealant without adhesive system (NO BOND) | Active comparator | Procedure: Fissure sealant without adhesive system (NO BOND)Teeth randomised to the control group will be using issure sealant without adhesive system (NO BOND) |
| Fissure sealant with adhesive system (BOND) | Experimental | Procedure: Fissure sealant with adhesive system (BOND)Teeth randomised to the test group will be treated using fissure sealant with adhesive system (BOND) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 6 to 12 years of age;
- Referred for dental treatment at the Dublin Dental University Hospital DDUH) or that are ongoing patients of the Paediatric dentistry clinic;
- With first permanent molars that are caries free or present caries lesions restricted to enamel (ICDAS 1 to 3) indicated for glass ionomer sealants.
- Whose parents agreed and consent to participate in the present research;
Key exclusion criteria (4 listed)
- Presence of any developmental defects
- Presence of any type of restorative/sealant material in the selected tooth;
- Presence of a dentine shadow (ICDAS 4) or dentine cavitation (ICDAS 5/6) detected clinically and/or radiographically14;
- Insufficient cooperation to achieve adequate moisture control using cotton roll isolation
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 |
|---|---|---|
| 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. | Procedure or surgery | Fissure sealant without adhesive system (NO BOND) |
| 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. | Procedure or surgery | Fissure sealant with adhesive system (BOND) |
Primary outcome
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.
2 secondary outcomes
Caries Progression
Time frame: Caries Progression will be evaluated after 1 and 2 years
Patient behaviour
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 29670708Memarpour M, Shafiei F, Zarean M, Razmjoei F. Sealing effectiveness of fissure sealant bonded with universal adhesive systems on saliva-contaminated and noncontaminated enamel. J Clin Exp Dent. 2018 Jan 1;10(1):e1-e6. doi: 10.4317/jced.54471. eCollection 2018 Jan.
- Background: PubMed 22889920Nazar H, Mascarenhas AK, Al-Mutwa S, Ariga J, Soparker P. Effectiveness of fissure sealant retention and caries prevention with and without primer and bond. Med Princ Pract. 2013;22(1):12-7. doi: 10.1159/000341155. Epub 2012 Aug 9.
- Background: PubMed 25864681McCafferty J, O'Connell AC. A randomised clinical trial on the use of intermediate bonding on the retention of fissure sealants in children. Int J Paediatr Dent. 2016 Mar;26(2):110-5. doi: 10.1111/ipd.12165. Epub 2015 Apr 10.
- Background: PubMed 27470525Wright JT, Crall JJ, Fontana M, Gillette EJ, Novy BB, Dhar V, Donly K, Hewlett ER, Quinonez RB, Chaffin J, Crespin M, Iafolla T, Siegal MD, Tampi MP, Graham L, Estrich C, Carrasco-Labra A. Evidence-based clinical practice guideline for the use of pit-and-fissure sealants: A report of the American Dental Association and the American Academy of Pediatric Dentistry. J Am Dent Assoc. 2016 Aug;147(8):672-682.e12. doi: 10.1016/j.adaj.2016.06.001.
- Background: PubMed 26359655San Martin-Galindo L, Rodriguez-Lozano FJ, Abalos-Labruzzi C, Niederman R. European Fissure Sealant Guidelines: assessment using AGREE II. Int J Dent Hyg. 2017 Feb;15(1):37-45. doi: 10.1111/idh.12174. Epub 2015 Sep 11.
- Background: PubMed 15471528Welbury R, Raadal M, Lygidakis NA; European Academy of Paediatric Dentistry. EAPD guidelines for the use of pit and fissure sealants. Eur J Paediatr Dent. 2004 Sep;5(3):179-84. No abstract available.
- Background: PubMed 27099357Innes NP, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona A, Schwendicke F. Managing Carious Lesions: Consensus Recommendations on Terminology. Adv Dent Res. 2016 May;28(2):49-57. doi: 10.1177/0022034516639276.
- Background: PubMed 26860292van Loveren C, van Palenstein Helderman W. EAPD interim seminar and workshop in Brussels May 9 2015 : Non-invasive caries treatment. Eur Arch Paediatr Dent. 2016 Feb;17(1):33-44. doi: 10.1007/s40368-015-0219-3. Epub 2016 Feb 10.
- Background: PubMed 31444695Schwendicke F, Splieth C, Breschi L, Banerjee A, Fontana M, Paris S, Burrow MF, Crombie F, Page LF, Gaton-Hernandez P, Giacaman R, Gugnani N, Hickel R, Jordan RA, Leal S, Lo E, Tassery H, Thomson WM, Manton DJ. When to intervene in the caries process? An expert Delphi consensus statement. Clin Oral Investig. 2019 Oct;23(10):3691-3703. doi: 10.1007/s00784-019-03058-w. Epub 2019 Aug 23.
- Background: PubMed 30290130Urquhart O, Tampi MP, Pilcher L, Slayton RL, Araujo MWB, Fontana M, Guzman-Armstrong S, Nascimento MM, Novy BB, Tinanoff N, Weyant RJ, Wolff MS, Young DA, Zero DT, Brignardello-Petersen R, Banfield L, Parikh A, Joshi G, Carrasco-Labra A. Nonrestorative Treatments for Caries: Systematic Review and Network Meta-analysis. J Dent Res. 2019 Jan;98(1):14-26. doi: 10.1177/0022034518800014. Epub 2018 Oct 5.
- Background: PubMed 20068302Splieth CH, Ekstrand KR, Alkilzy M, Clarkson J, Meyer-Lueckel H, Martignon S, Paris S, Pitts NB, Ricketts DN, van Loveren C. Sealants in dentistry: outcomes of the ORCA Saturday Afternoon Symposium 2007. Caries Res. 2010;44(1):3-13. doi: 10.1159/000271591. Epub 2009 Dec 31.
- Background: PubMed 16352882Beiruti N, Frencken JE, van't Hof MA, Taifour D, van Palenstein Helderman WH. Caries-preventive effect of a one-time application of composite resin and glass ionomer sealants after 5 years. Caries Res. 2006;40(1):52-9. doi: 10.1159/000088907.
- Individual participant dataSharing planned: Undecided
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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.
Rona Leith principal investigator
DDUH - Trinity College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fissure sealant without adhesive system (NO BOND) and Fissure sealant with adhesive system (BOND) in people with Dental Caries and Fissure Sealant, run by University of Dublin, Trinity College at 1 site in Ireland.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. 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 Ireland. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sealant Retention (time frame: Sealant retention will be evaluated after 1 and 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06608563, which also lists 14 linked publications.
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 15 Sep 2026.