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Status unknownNCT03184025Updated Jun 12, 2017

Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations

An interventional study of dentin adhesive in Dental Caries, Class I Dental Caries and Dental Composite, sponsored by Neslihan Tekçe. Status unknown. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-12.

Sponsored by Neslihan Tekçe · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Caries
  • Class I Dental Caries
  • Dental Composite

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03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrollment
40 participants (actual)

Study arms

  • Other
    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

Interventions

  • Otherdentin adhesive

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

05

What researchers measure

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.

    Time frame: an average of 1 year

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Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03184025
Lead sponsor
Neslihan Tekçe
Responsible party
Neslihan Tekçe (Faculty of Dentistry, Kocaeli University) — Sponsor-investigator
First posted
Jun 12, 2017
Start date
Jul 1, 2014
Primary completion
Dec 29, 2014
Completion
Dec 29, 2020 (estimated)
Last update
Jun 12, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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