search
Back to results

Radiographic Evaluation of Adaptation of Universal Adhesives

Primary Purpose

Class II Dental Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Scotchbond universal adhesive plus
Single bond Universal
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Dental Caries

Eligibility Criteria

19 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Small to moderate carious proximal lesions. (International caries detection and assessment system (ICDAS) scores 3,4) Good oral hygiene (mild to moderate plaque accumulation) Vital teeth with no signs of irreversible pulpitis. Presence of favorable occlusion and normal contact with adjacent teeth. Exclusion Criteria: Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates. Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia. Evidence of parafunctional habits and tempromandibular joint disorders. Deep carious defects (close to pulp, less than 1 mm distance). Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Endodontically treated teeth. Tooth hypersensitivity. Possible prosthodontic restoration of teeth. Heavy occlusion and occlusal contacts or history of bruxism. Severe periodontal affection.

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radio-opaque universal adhesive

Conventional universal adhesive

Arm Description

Radio-opaque universal adhesive

Conventional universal adhesive

Outcomes

Primary Outcome Measures

Radiographic Assessment of adaptation of restoration
Modified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
June 14, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05907928
Brief Title
Radiographic Evaluation of Adaptation of Universal Adhesives
Official Title
Radiographic Evaluation of Adaptation of New Radio-opaque Universal Adhesive Compared to Universal Adhesive in Proximal Restorations: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

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
Class 2 restorations are analyzed to see whether or not the use of modified universal adhesive will result in similar adaptation to conventional universal adhesive.
Detailed Description
The newly modified adhesive with its careful formulation offers: Radiopacity like dentin to reduce the risk of X-ray misdiagnosis and overtreatment. Ability to bond and seal caries-affected dentin to support minimally invasive preparation guidelines and maximize preservation of natural tooth structure. Adhesion to all dental substrates and all direct and indirect materials, including glass ceramics. Full dual- and self-cure compatibility without the need for an additional dual-cure activator bottle. A bisphenol A (BPA) derivative-free formulation to alleviate concerns about BPA in dental materials. A fully aligned system with RelyX™ Universal Resin Cement, offering excellent bond strength for virtually all dual-cure resin cement indications. As with any new material or technique, clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. Therefore, the aim of the current study was to evaluate adaptation of class 2 restorations either using radio-opaque universal adhesive or universal adhesive using digital radiography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radio-opaque universal adhesive
Arm Type
Experimental
Arm Description
Radio-opaque universal adhesive
Arm Title
Conventional universal adhesive
Arm Type
Active Comparator
Arm Description
Conventional universal adhesive
Intervention Type
Other
Intervention Name(s)
Scotchbond universal adhesive plus
Intervention Description
New generation BPA free universal adhesive
Intervention Type
Other
Intervention Name(s)
Single bond Universal
Other Intervention Name(s)
Scotchbond universal adhesive
Intervention Description
Radiolucent universal adhesive
Primary Outcome Measure Information:
Title
Radiographic Assessment of adaptation of restoration
Description
Modified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Small to moderate carious proximal lesions. (International caries detection and assessment system (ICDAS) scores 3,4) Good oral hygiene (mild to moderate plaque accumulation) Vital teeth with no signs of irreversible pulpitis. Presence of favorable occlusion and normal contact with adjacent teeth. Exclusion Criteria: Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates. Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia. Evidence of parafunctional habits and tempromandibular joint disorders. Deep carious defects (close to pulp, less than 1 mm distance). Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Endodontically treated teeth. Tooth hypersensitivity. Possible prosthodontic restoration of teeth. Heavy occlusion and occlusal contacts or history of bruxism. Severe periodontal affection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Shaalan, PhD
Phone
01122665661
Email
omar.shaalan@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Shaalan, PhD
Organizational Affiliation
Lecturer, Department of Conservative Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
State/Province
El Manial
ZIP/Postal Code
11553
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radiographic Evaluation of Adaptation of Universal Adhesives

We'll reach out to this number within 24 hrs