Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations

NCT03184025 | Unknown

• 1 other identifier: 2014/239
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries; Class I Dental Caries; Dental Composite

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients have class I caries

OTHER

patients have received four restorations which included HEMA containing and HEMA-free dentin adhesive with or without surface sealing

Other: dentin adhesive

Interventions

dentin adhesive OTHER

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

patients have class I caries

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neslihan Tekçe: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty of Dentistry

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 12, 2017
• Study Start: July 1, 2014
• Primary Completion: December 29, 2014
• Study Completion: December 29, 2020
• Last Updated: June 12, 2017

Record last verified: 2017-06