Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations

Dental Caries Clinical Trial

Official title:

Effect of Surface Sealant Application on Clinical Performance of HEMA Containing and HEMA-free Self-Etch Adhesives

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03184025
• Other study ID #: 2014/239
• Status: Active, not recruiting
• Phase: N/A
• First received: June 7, 2017
• Last updated: June 9, 2017
• Start date: July 1, 2014
• Est. completion date: December 29, 2020

Study information

• Verified date: June 2017
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 29, 2020
• Est. primary completion date: December 29, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class I Dental Caries
• Dental Caries
• Dental Composite

Intervention

Other:
• dentin adhesive
HEMA-containing and HEMA-free Self-Etch dentin adhesives clinical performance with or without surface sealant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neslihan Tekçe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.	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