Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month
Primary Purpose
Fissure, Dental, Adhesion
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fissure sealant application
Sponsored by
About this trial
This is an interventional prevention trial for Fissure, Dental focused on measuring fissure sealant, adhesive
Eligibility Criteria
Inclusion Criteria:
- good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.
Exclusion Criteria:
- bad oral health, maloclusion, allergy to resins used
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Universal Adhesive
Etch-And-Rinse Adhesive
Arm Description
universal adhesive
Etch-And-Rinse Adhesive
Outcomes
Primary Outcome Measures
The evaluation of retention rate of fissure sealants
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04837469
Brief Title
Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month
Official Title
Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
February 1, 2015 (Actual)
Study Completion Date
March 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Thirteen patients with a mean age of 20.5 (range 19-22) were selected among the patients seeking routine dental care from Conservative Dentistry Department who met the inclusion criteria. Inclusion criteria were: good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.
Bitewing radiographs were taken. Pellicle and any remaining plaque on the fissures were removed by using slurry of pumice with a slow-speed handpiece. All restorative procedures were performed by the same operator. The teeth were assigned for different group by using a table of random numbers.
Group 1 (SB2): Etched with 35% phosphoric acid gel for 30 s, rinsed and dried. Adper Single Bond 2 (3M ESPE St. Paul MN. USA) applied and light cured for 10s with a LED device (Demi Plus; Kerr, Switzerland) Group 2 (SBU-ER) : Etched with 35% phosphoric acid gel for 30s, rinsed and dried. Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied, gently air thinned for 5 s and light cured for 10s with a LED device Group 3 (SBU-SE): Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied for 20 s with vigorous agitation, gently air thinned for 5 s and light cured for 10 s with a LED device A nanofilled fissure sealant, Fissurit FX (Voco,Cuxhaven,Germany) was applied to the fissures and air entrapment was prevented by carefull spreading with a dental probe. The sealant material was light-cured for 20 seconds with LED. The occlusion was checked with articulating paper. Fine-grit diamond burs (Diatech, Swiss Dental, Switzerland) and rubber cups (Edenta AG, AU SG, Switzerland). were used for finishing and polishing.
Each restoration was evaluated at baseline,1week after treatment and 6, 12, 18 and 24 months. Evaluation of restorations was carried out by two calibrated examiners who were unaware of group allocation and who were not involved with the treatment procedures, by the help of a mirror, blunt explorer and air stream. Caries formation was evaluated as present or absent and the sealants were evaluated according to the following criteria: 1= Completely retained 2= Partial loss 3= Total loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fissure, Dental, Adhesion
Keywords
fissure sealant, adhesive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Universal Adhesive
Arm Type
Experimental
Arm Description
universal adhesive
Arm Title
Etch-And-Rinse Adhesive
Arm Type
Experimental
Arm Description
Etch-And-Rinse Adhesive
Intervention Type
Procedure
Intervention Name(s)
fissure sealant application
Intervention Description
fissure sealants were placed after differnt adhesive strategies used
Primary Outcome Measure Information:
Title
The evaluation of retention rate of fissure sealants
Time Frame
24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.
Exclusion Criteria:
bad oral health, maloclusion, allergy to resins used
12. IPD Sharing Statement
Plan to Share IPD
No
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Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month
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