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Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03184025
Enrollment
40
Registered
2017-06-12
Start date
2014-07-01
Completion date
2020-12-29
Last updated
2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class I Dental Caries, Dental Caries, Dental Composite

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.

Interventions

OTHERdentin adhesive

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

Sponsors

Neslihan Tekçe
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.an average of 1 yearIn 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026