- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184025
Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations
June 9, 2017 updated by: Neslihan Tekçe
Effect of Surface Sealant Application on Clinical Performance of HEMA Containing and HEMA-free Self-Etch Adhesives
The aim was to evaluate the clinical performance of HEMA-containing and HEMA-free all-in-one self-etch adhesives with and without a surface sealing process with a nanohybrid composite in occlusal caries restorations.
The hypothesis is that the HEMA-containing and HEMA-free all-in-one self-etch adhesive and the surface sealing process would significantly effect clinical performance of occlusal restorations.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who received four direct Class I composite restorations, those with good oral hygiene with no active periodontal or pulpal diseases, whose permanent first or second molar required restorations for occlusal carious lesions with neighboring teeth and were in occlusion with antagonist teeth, and were willing to return for follow-up examinations as outlined by the investigators.
Exclusion Criteria:
- patients with uncontrolled parafunction, those presenting with poor oral hygiene and disinterested in or refused oral hygiene instructions, molars and premolars with carious lesions on a surface other than the occlusal surface and in continuity with the occlusal cavity, pulp exposure during caries removal procedure or cavities with the risk of pulp exposure, having spontaneous pain or sensitivity to percussion, and patients with periodontal or gingival disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: patients have class I caries
patients have received four restorations which included HEMA containing and HEMA-free dentin adhesive with or without surface sealing
|
HEMA-containing and HEMA-free Self-Etch dentin adhesives clinical performance with or without surface sealant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.
Time Frame: an average of 1 year
|
In restorations, retention rate, color match, wear or loss of anatomic form, marginal discoloration, caries, marginal adaptation, and surface texture were scored success or failure according to modified United States Public Health Service (USPHS) criteria.
According to this criteria, success restorations received Alfa (A) or Bravo (B) scores.
Alfa (A) represents the ideal clinical situation; Bravo (B) is the clinically acceptable.
Failed restorations received Charlie (C) or Delta (D) scores.
Charlie (C) is the clinically unacceptable situations where the restorations had to be replaced; Delta (D) is the situation where the restoration is fractured, mobile or missing and needed to be replaced immediately.
|
an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2014
Primary Completion (Actual)
December 29, 2014
Study Completion (Anticipated)
December 29, 2020
Study Registration Dates
First Submitted
June 7, 2017
First Submitted That Met QC Criteria
June 9, 2017
First Posted (Actual)
June 12, 2017
Study Record Updates
Last Update Posted (Actual)
June 12, 2017
Last Update Submitted That Met QC Criteria
June 9, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/239
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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