Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations

Not Applicable

• Conditions: Class I Dental Caries; Dental Caries; Dental Composite
• Interventions: Other: dentin adhesive

• Registration Number: NCT03184025
• Lead Sponsor: Neslihan Tekçe

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2014-12-29
• Status Verified: 2017-06
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-09
• Last Update Submitted: 2017-06-09
• Study First Posted: 2017-06-12
• Last Update Posted: 2017-06-12
• Study Completion: 2020-12-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients have class I caries	dentin adhesive	patients have received four restorations which included HEMA containing and HEMA-free dentin adhesive with or without surface sealing

Primary Outcome Measures

Name	Time	Method
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.	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.