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OpenTrials
Completed

NCT Number: NCT04053530

Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: RCCT

The study will be conducted to assess the marginal integrity of different types of restorations (ketac ™ N100 - ketac™ Universal and bulk fill flowable composite) in class v restoration using USPHS criteria.

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Key information

Conditions

Dental Caries Class v

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University, Cairo, Egypt

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of at least one carious buccal cervical lesion.
  • The absence of tooth mobility.
  • Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
  • Accessible isolation and observable and easily accessible gingival margins during tooth restoration.

Exclusion criteria

  • Patients with poor oral hygiene.
  • The presence of any para functional habit.
  • Abnormal occlusion.
  • Any regurgitation problem.
  • Subjects with compromised medical history.
  • Pulpitis, non-vital or endodontically treated teeth.

Treatment and study plan

restorative materials

Other

glass ionomer and bulk fill flowable composite

Primary outcomes

  1. is marginal integrity of restoration.

    Time frame: 12 months

    Primary outcome is marginal integrity of restoration. It will be assessed by USPHS; score will be recorded according to USPHS criteria (Nassar et al., 2014).

    • MARGINAL INTEGRITY

    Alpha (A) Visual inspection and explorer The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration.

    Bravo (B) Visual inspection and explorer The explorer catches and there is visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile.

    Charlie (C) Explorer The explorer penetrates crevice defect extended to the dentino-enamel junction.

    Delta (D) Mobile, fractured or missing restoration in a part or total

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: Randomized Controlled Clinical Trail

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2019
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.