Post-operative Sensitivity of a Self-adhesive Restorative Material

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

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

Study Overview

• Status: Recruiting
• Conditions: Dental Restorations, Permanent
• Intervention / Treatment: Procedure: Bulk-fill resin composite, (3M, ESPE); Procedure: Surefil one™ Self-Adhesive Composite Hybrid

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghada A Maghaireh; Phone Number: 00962798809296; Email: gmaghair@just.edu.jo

Study Locations

• Jordan
  • Irbid, Jordan
    • Recruiting
    • Jordan University of Science and Technology
    • Contact: Ghada A Maghaireh; Phone Number: 00962798809296; Email: gmaghair@just.edu.jo
    • Sub-Investigator: Zakereyya S Albashaireh
    • Sub-Investigator: Hadeel A Allouz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bulk- Fill; Restorative procedure of the teeth will be performed using Filtek-Bulk Fill Posterior Restorative, Bulk-fill resin composite, (3M, ESPE) following application of an etch-and-rinse single bottle adhesive (3M, ESPE).	Procedure: Bulk-fill resin composite, (3M, ESPE); Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)
Experimental: Surefill One; Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona),	Procedure: Surefil one™ Self-Adhesive Composite Hybrid; teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The post-operative sensitivity.	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.	One month after the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance of the restorations	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.	6 months and 1 year after the treatment.

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital
• Collaborators: Jordan University of Science and Technology
• Investigators: Principal Investigator: Ghada A Maghaireh, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Composite, self-adhesive, sensetivity
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 20210419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No