NCT04837469

Brief Summary

Objective: This randomized, controlled clinical study aimed to evaluate the performance of one universal adhesive applied with etch-and-rinse or self-etch strategy and one etch-and-rinse adhesive on fissure sealant retention over 24 months. Methodology: 144 sealants were placed on the permanent premolars and molars of 13 subjects. Teeth were divided into three groups SB2(control): Adper Single Bond 2, SBU-ER: Single Bond Universal/etch-and-rinse, SBU-SE: Single Bond Universal/self-etch. After the adhesive application, Fissurit FX was applied and light-cured. Clinical evaluations were done at baseline and at 1 week, 6-, 12-, 18- and 24-month recalls. Visual examination was performed on every visit for evaluation of the sealants. Evaluating criteria were: 1= completely retained; 2= partial loss; 3= total loss. The Pearson Chi-square test was used for each evaluation period.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

April 5, 2021

Last Update Submit

April 7, 2021

Conditions

Fissure, DentalAdhesion

Keywords

fissure sealant, adhesive

Outcome Measures

Primary Outcomes (1)

  • The evaluation of retention rate of fissure sealants

    24 month

Study Arms (2)

Universal Adhesive

EXPERIMENTAL

universal adhesive

Procedure: fissure sealant application

Etch-And-Rinse Adhesive

EXPERIMENTAL

Etch-And-Rinse Adhesive

Procedure: fissure sealant application

Interventions

fissure sealant applicationPROCEDURE

fissure sealants were placed after differnt adhesive strategies used

Etch-And-Rinse AdhesiveUniversal Adhesive

Eligibility Criteria

Age19 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.

You may not qualify if:

  • bad oral health, maloclusion, allergy to resins used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental FissuresTissue Adhesions

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesTooth DiseasesStomatognathic DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 8, 2021

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2016

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share