Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

Dental Caries on Pit and Fissure Surface Clinical Trial

Official title:

Clinical Performance of Fissure Sealants Bonded With Total and Self-etch Modes of Universal Adhesive Agents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02897089
• Other study ID #: HUDHF-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2021
• Source: Hacettepe University
• Contact: Zafer C Cehreli, Prof
• Phone: 00903123052280
• Email: zcehreli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare the clinical retention of a resin-based fissure sealant placed with prior application of etch-and-rinse and self-etch modes of universal adhesives.

Description:

Sealants will placed on previously unsealed, caries-free permanent first molars, employing a split-mouth design. 100 patients will be included the study. The teeth will be randomized into eight groups according to the adhesive systems and modes placed under the tested resin-based sealant.

Group1: Acid-Etch + Fissure sealant (ClinPro 3M ESPE, U.S.) (Control arm) Group2: All Bond Universal (Bisco Inc., Schaumburg,IL, U.S.) - with self etch technique + Fissure sealant ; Group3: All Bond Universal - total etch technique + Fissure sealant Group4: Scotchbond (Single Bond) Universal (3M ESPE, U.S.) - self etch technique + Fissure sealant Group5: Scotchbond (Single Bond) Universal - total etch technique + Fissure sealant Group6: Clearfil Universal Bond (Kuraray, Tokyo, Japan) - self etch technique + Fissure sealant Group7: Clearfil Universal Bond- total etch technique + Fissure sealant Group8: Single Bond Plus (3M ESPE)- total etch technique + Fissure sealant

Clinical assessments will be performed according to modified USPHS criteria at 3, 6, 12, 18 and 24 months. Retention, seconder caries, marginal adaptation and marginal discoloration of the sealants will be evaluated.

The data will be analyzed statistically using Fisher's Exact test and Kaplan-Meier analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• Teeth having clinical indication of sealing with pit and fissure sealant.

• Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures.

Exclusion Criteria:

• Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.

• Patients with systemic diseases.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries on Pit and Fissure Surface

Intervention

Device:
• Adhesive agent
Agents used to bond the restorative materials to teeth structure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

References & Publications (3)

Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. — View Citation

Karaman E, Yazici AR, Tuncer D, Firat E, Unluer S, Baseren M. A 48-month clinical evaluation of fissure sealants placed with different adhesive systems. Oper Dent. 2013 Jul-Aug;38(4):369-75. doi: 10.2341/12-181-C. Epub 2012 Dec 4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria	Long-term clinical success of different universal adhesives under fissure sealants	24 months