search
Back to results

Post-operative Sensitivity of a Self-adhesive Restorative Material

Primary Purpose

Dental Restorations, Permanent

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Bulk-fill resin composite, (3M, ESPE)
Surefil one™ Self-Adhesive Composite Hybrid
Sponsored by
King Abdullah University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Restorations, Permanent focused on measuring Composite, self-adhesive, sensetivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jordan University of Science and technologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bulk- Fill

Surefill One

Arm Description

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).

Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona),

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 3, 2022
Last Updated
November 7, 2022
Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT05567263
Brief Title
Post-operative Sensitivity of a Self-adhesive Restorative Material
Official Title
Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Restorations, Permanent
Keywords
Composite, self-adhesive, sensetivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The design of study will be a split-mouth randomized clinical trial with two study groups.
Masking
Participant
Masking Description
All participants will be informed about the nature and objectives of the study; however, they will not be informed what material they would receive.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bulk- Fill
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Surefill One
Arm Type
Experimental
Arm Description
Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona),
Intervention Type
Procedure
Intervention Name(s)
Bulk-fill resin composite, (3M, ESPE)
Intervention Description
Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)
Intervention Type
Procedure
Intervention Name(s)
Surefil one™ Self-Adhesive Composite Hybrid
Intervention Description
teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid
Primary Outcome Measure Information:
Title
The post-operative sensitivity.
Description
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.
Time Frame
One month after the treatment.
Secondary Outcome Measure Information:
Title
Clinical performance of the restorations
Description
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.
Time Frame
6 months and 1 year after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghada A Maghaireh
Phone
00962798809296
Email
gmaghair@just.edu.jo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada A Maghaireh
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and technology
City
Irbid
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghada A Maghaireh
Phone
00962798809296
Email
gmaghair@just.edu.jo
First Name & Middle Initial & Last Name & Degree
Zakereyya S Albashaireh
First Name & Middle Initial & Last Name & Degree
Hadeel A Allouz

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Post-operative Sensitivity of a Self-adhesive Restorative Material

We'll reach out to this number within 24 hrs