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OpenTrials
Completed

NCT Number: NCT05567263

Post-operative Sensitivity of a Self-adhesive Restorative Material

Adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. However, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. In addition, the continuing discussions on the clinical use of dental amalgam and the feasibility of a phase out of the use of dental amalgam in the long term has become a central concern for restorative dentistry and has led to strong efforts to develop a substitute material for amalgam. With the goal of clinically shorter application times and lower technique sensitivity, the development of an advanced self-adhesive restorative tooth-colored restorative materials (ASAR) that no longer need pre-treatment with a separate adhesive have been under investigation. The aim of this study is to assess the post-operative sensitivity following restoration of teeth using a self-adhesive tooth-colored restorative material and to assess its clinical performance in comparison with conventional resin-based composite in posterior restorations

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and technology

Irbid, Jordan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient is at least 18 years' old
  • Teeth are vital
  • Teeth are periodontal healthy
  • Tooth to be restored in normal occlusion with natural antagonist and adjacent teeth
  • Patient did not receive orthodontic treatment
  • Good level of oral hygiene.

Exclusion criteria

  • Non-vital or endodontically treated teeth
  • (Profound, chronic) periodontitis
  • Deep carious defects (close to pulp, < 1mm distance)
  • Heavy occlusal contacts or history of bruxism
  • Poor oral hygiene
  • Sustained dentin hypersensitivity
  • Taking anti-inflammatory, analgesic, or psychotropic drugs

Treatment and study plan

Bulk-fill resin composite, (3M, ESPE)

Procedure

Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)

Surefil one™ Self-Adhesive Composite Hybrid

Procedure

teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid

Primary outcomes

  1. The post-operative sensitivity.

    Time frame: One month after the treatment.

    For the evaluation of post-operative sensitivity, participants will be asked to record whether they experienced sensitivity using a 0-4 numerical rating scale (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe). The patients will be asked to fill in the pain scale forms 24 hours after the restorative procedure and daily up to seven days, and at 2 weeks and 1 month intervals.

Secondary outcomes

  1. Clinical performance of the restorations

    Time frame: 6 months and 1 year after the treatment.

    All restorations will be evaluated at 6 months and 1-year post-restoration using the United States Public Health Service, USPHS criteria using the Alpha, Bravo and Charlie scale to evaluate the following parameters: retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2022
Registry last updated
Jul 12, 2024

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.