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
About this trial
This is an interventional treatment trial for Dental Restorations, Permanent focused on measuring Composite, self-adhesive, sensetivity
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
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
NCT ID
NCT05567263
First Posted
October 3, 2022
Last Updated
November 7, 2022
Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology
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
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