Clinical Evaluation Fissure Sealants Applied With Different Isolation Techniques

NCT07110701 | Completed

• 1 other identifier: 2025/059
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study was to evaluate the effects of different isolation methods and material filler ratios on the retention rates of two different fluoride-containing fissure sealants over an 18-month period. Methods: A total of 100 children (200 teeth) participated in this randomized, single-blind, split-mouth clinical trial. The mandibular permanent first molars of each participant were divided into two groups: one receiving a highly filled fluoride-releasing fissure sealant (Fissurit FX, Voco, Germany), and the other an unfilled fluoride-releasing sealant (Teethmate F-1, Kuraray, Germany). Each material group was also divided into two subgroups based on the isolation method used: rubber dam or cotton roll isolation. Sealant retention rates were evaluated at 6-, 12-, and 18-month follow-up visits. Data were statistically analyzed using a 0.05 significance level.

Conditions

Fissure Sealant; Rubberdam; Isolation

Keywords

Resin-Based Fissure Sealants; isolation techniques; rubberdam

Outcome Measures

Primary Outcomes (1)

• The retention rates of two different resin-based fissure sealant materials (a pit and fissure sealant containing high-filler fluoride and a pit and fissure sealant containing non-filler fluoride)

  Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.

  The evaluation of pit-and-fissure sealants was conducted to record the presence of caries lesions and sealant retention at 6-, 12-, and 18-month follow-up visits.

Study Arms (4)

a highly filled fluoride-containing fissure sealant with rubber dam isolation

ACTIVE COMPARATOR

Plaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in conjunction with a non-fluoridated prophylactic paste. In accordance with the randomization protocol, and subsequent to the allocation of materials and isolation techniques for each quadrant, individual teeth were isolated using a rubber dam to ensure optimal protection against salivary contamination. All clinical procedures were performed under standardized illumination and strictly adhered to the manufacturers' guidelines. The polymerization of the highly filled, fluoride-releasing fissure sealant was executed using a calibrated LED light-curing unit. Following application, each sealant was rigorously assessed for the absence of air entrapment, quality of marginal adaptation, retention, and the adequacy of polymerization.

Other: Retention of the fissure sealants evaluated

a highly filled fluoride-containing fissure sealant with cotton roll isolation,

ACTIVE COMPARATOR

Plaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in combination with a non-fluoridated prophylactic paste. In line with the randomization protocol and subsequent allocation of the materials and isolation methods for each side of the patient, individual teeth were isolated using cotton rolls in conjunction with high-volume suction to minimize the risk of salivary contamination. All procedures were performed under standardized illumination and strictly followed the manufacturers' instructions. Polymerization of the highly filled, fluoride-releasing fissure sealant was carried out using a calibrated LED light-curing unit. Following application, each sealant was carefully evaluated for the presence of air voids, the quality of marginal adaptation, retention, and the completeness of polymerization.

Other: Retention of the fissure sealants evaluated

an unfilled fluoride-containing fissure sealant with rubber dam isolation,

ACTIVE COMPARATOR

Plaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in conjunction with a non-fluoridated prophylactic paste. In accordance with the randomization protocol and following the allocation of materials and isolation methods for each side of the patient, individual teeth were isolated using a rubber dam to ensure effective prevention of salivary contamination. All clinical procedures were performed under standardized illumination and in strict compliance with the manufacturers' instructions. Polymerization of the unfilled, fluoride-releasing fissure sealant was performed using a calibrated LED light-curing unit. Following the application, each sealant was thoroughly evaluated for the presence of air voids, marginal adaptation, retention, and completeness of polymerization.

Other: Retention of the fissure sealants evaluated

an unfilled fluoride-containing fissure sealant with cotton roll isolation.

ACTIVE COMPARATOR

Plaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in combination with a non-fluoridated prophylactic paste. In line with the randomization protocol and subsequent determination of the materials and isolation techniques for each side of the patient, individual teeth were isolated using cotton rolls in conjunction with high-volume suction to minimize salivary contamination. All procedures were carried out under standardized illumination and in strict accordance with the manufacturers' recommendations. Polymerization of the unfilled, fluoride-releasing fissure sealant was performed using a calibrated LED light-curing unit. Following each application, the sealant was thoroughly evaluated for the presence of air voids, quality of marginal adaptation, retention, and completeness of polymerization.

Other: Retention of the fissure sealants evaluated

Interventions

Retention of the fissure sealants evaluated OTHER

Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.

a highly filled fluoride-containing fissure sealant with cotton roll isolation,; a highly filled fluoride-containing fissure sealant with rubber dam isolation; an unfilled fluoride-containing fissure sealant with cotton roll isolation.; an unfilled fluoride-containing fissure sealant with rubber dam isolation,

Eligibility Criteria

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

You may qualify if:

• The study comprised 100 healthy children aged between 6 and 12 years
• ASA class I (American Society of Anesthesiologists),
• exhibit cooperative behavior with a score of 3 or 4 on the Frankl Behavior Rating Scale.
• All participants has to be fully erupted lower first permanent molars on both sides (200 teeth), which required the application of pit and fissure sealants.

You may not qualify if:

• Participants with special needs or systemic disease (ASA classification II or higher),
• requiring emergency dental care,
• suffering from a severe gag reflex or an allergy to latex,
• exhibiting uncooperative behavior (Frankl Score 1 or 2),
• exhibiting molars with anomalies of the enamel/dentin, or
• unable to attend follow-up appointments were excluded from the study.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

Related Publications (9)

• Hicks MJ, Flaitz CM. Epidemiology of dental caries in the pediatric and adolescent population: a review of past and current trends. J Clin Pediatr Dent. 1993 Fall;18(1):43-9.

  PMID: 8110613 BACKGROUND

• Brown LJ, Kaste LM, Selwitz RH, Furman LJ. Dental caries and sealant usage in U.S. children, 1988-1991: selected findings from the Third National Health and Nutrition Examination Survey. J Am Dent Assoc. 1996 Mar;127(3):335-43. doi: 10.14219/jada.archive.1996.0203.

  PMID: 8819780 BACKGROUND

• Bahrololoomi Z, Soleymani A, Heydari Z. In vitro comparison of microleakage of two materials used as pit and fissure sealants. J Dent Res Dent Clin Dent Prospects. 2011 Summer;5(3):83-6. doi: 10.5681/joddd.2011.019. Epub 2011 Sep 5.

  PMID: 22991611 BACKGROUND

• Deery C. Caries detection and diagnosis, sealants and management of the possibly carious fissure. Br Dent J. 2013 Jun;214(11):551-7. doi: 10.1038/sj.bdj.2013.525.

  PMID: 23744208 BACKGROUND

• Ripa LW. Sealants revisted: an update of the effectiveness of pit-and-fissure sealants. Caries Res. 1993;27 Suppl 1:77-82. doi: 10.1159/000261608.

  PMID: 8500131 BACKGROUND

• Ahovuo-Saloranta A, Hiiri A, Nordblad A, Worthington H, Makela M. Pit and fissure sealants for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev. 2004;(3):CD001830. doi: 10.1002/14651858.CD001830.pub2.

  PMID: 15266455 BACKGROUND

• Feigal RJ. The use of pit and fissure sealants. Pediatr Dent. 2002 Sep-Oct;24(5):415-22.

  PMID: 12412955 BACKGROUND

• Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.

  PMID: 18310730 BACKGROUND

• Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.

  PMID: 25303507 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A split-mouth study design was implemented, in which two distinct fissure sealant materials were applied using two different isolation techniques. Each participant received both types of sealants-one placed under rubber dam isolation and the other under cotton roll isolation. To reduce the risk of allocation bias, the assignment of sealant materials and isolation methods to specific teeth was randomized. A computer-generated randomization list (Research Randomizer, Version 4.0) was used to determine both the order of sealant application and the side (right or left mandibular molar) to which each material would be assigned. Based on the combination of sealant type and isolation method, this process resulted in the creation of four distinct study groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: The randomized, controlled, single-blind clinical study

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 7, 2025
• Study Start: June 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: March 14, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)