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Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03184025
Recruitment Status : Unknown
Verified June 2017 by Neslihan Tekçe, Kocaeli University.
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Information provided by (Responsible Party):
Neslihan Tekçe, Kocaeli University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Caries Class I Dental Caries Dental Composite Other: dentin adhesive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Effect of Surface Sealant Application on Clinical Performance of HEMA Containing and HEMA-free Self-Etch Adhesives
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : December 29, 2014
Estimated Study Completion Date : December 29, 2020

Arm Intervention/treatment
patients have class I caries
patients have received four restorations which included HEMA containing and HEMA-free dentin adhesive with or without surface sealing
Other: dentin adhesive
HEMA-containing and HEMA-free Self-Etch dentin adhesives clinical performance with or without surface sealant

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: Neslihan Tekçe, Faculty of Dentistry, Kocaeli University Identifier: NCT03184025    
Other Study ID Numbers: 2014/239
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases