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

NCT06608563 | Recruiting DMC

• 1 other identifier: 231104_ResinFS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Caries; Fissure Sealant

Keywords

fissure sealant; first permanent molar; retention; adhesive system; children; clinical trial; caries

Outcome Measures

Primary Outcomes (1)

• 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.

  Sealant retention will be evaluated after 1 and 2 years.

Secondary Outcomes (2)

• Caries Progression

  Caries Progression will be evaluated after 1 and 2 years

• Patient behaviour

  Immediately after the procedure

Study Arms (2)

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)

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)

Procedure: Fissure sealant with adhesive system (BOND)

Interventions

Fissure sealant without adhesive system (NO BOND) PROCEDURE

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.

Fissure sealant without adhesive system (NO BOND)

Fissure sealant with adhesive system (BOND) PROCEDURE

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.

Fissure sealant with adhesive system (BOND)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

Dublin Dental University Hospital - Trintiy College Dublin

Dublin, Dublin, D02 F859, Ireland

RECRUITING

Related Publications (14)

• 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.

  PMID: 29670708 BACKGROUND

• Nazar 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.

  PMID: 22889920 BACKGROUND

• McCafferty 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.

  PMID: 25864681 BACKGROUND

• Wright 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.

  PMID: 27470525 BACKGROUND

• San 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.

  PMID: 26359655 BACKGROUND

• Welbury 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.

  PMID: 15471528 BACKGROUND

• Innes 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.

  PMID: 27099357 BACKGROUND

• van 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.

  PMID: 26860292 BACKGROUND

• Schwendicke 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.

  PMID: 31444695 BACKGROUND

• Urquhart 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.

  PMID: 30290130 BACKGROUND

• Splieth 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.

  PMID: 20068302 BACKGROUND

• Beiruti 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.

  PMID: 16352882 BACKGROUND

• Ismail 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.

  PMID: 17518963 BACKGROUND

• Oba 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.

  PMID: 19933027 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Pit and Fissure Sealants

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Rona Leith

  DDUH - Trinity College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rona Leith, BDentSc DChDent

CONTACT

+353 01 6127303; rona.leith@dental.tcd.ie

Grace Gill, Division 1 Secretary

CONTACT

+353 016127303; grace.gill@dental.tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor (independent examiner) and participants will be blind to study groups. It is not possible to blind the operator due to differences in material capsule colours/consistency at the time of fissure sealant placement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Double-blind 2-arm parallel controlled randomised clinical trial.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: June 5, 2024
• Primary Completion: June 5, 2025
• Study Completion (Estimated): June 5, 2027
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

IE (1)