Back to resultsDentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide
Primary Purpose
Pulp Disease, Dental, Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bioactive Glass
Light cured calcium hydroxide
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Disease, Dental
Eligibility Criteria
Inclusion Criteria:
- Active carious lesion in deep dentin of molars.
- Absence of cavitated lesions at the buccal or lingual surfaces as determined by clinical and radiographic examination.
- Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and abnormal tooth mobility;
- Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure;
- The extension of the carious lesion should be such that complete caries removal would risk pulp exposure, as determined by clinical and radiographic assessment;
- Absence of radiolucencies at the interradicular or periapical regions, or thickening of the periodontal spaces, that would indicate the presence of irreversible pulp pathologies or necrosis;
- Absence of internal or external root resorption.
- Co-operative patients approving the trial.
Exclusion Criteria:
- Patients with systemic medical conditions
- pregnant females
- Teeth with spontaneous pain or sensitivity to percussion.
- Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
- Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
Sites / Locations
- AlAzhar University, Faculty of Dentistry for Girls
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bioactive Glass
Light cured calcium hydroxide
Arm Description
18 teeth were capped indirectly with dental adhesive containing bioactive glass applied according to the manufacturer's instructions and cured for 20 seconds and then resin composite restoration containing bioactive glass applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.
18 teeth were capped indirectly with light cured calcium hydroxide (control group) applied according to the manufacturer's instructions by calcium hydroxide applicator and light cured for 20 seconds then resin composite restoration was applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.
Outcomes
Primary Outcome Measures
Change of dentine thickness
Thickness in millimeters using CBCT
Secondary Outcome Measures
Full Information
NCT ID
NCT04274920
First Posted
February 10, 2020
Last Updated
February 17, 2020
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT04274920
Brief Title
Dentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide
Official Title
Clinical Response of Human Pulps Capped With Bioactive Glass Incorporated in Resin Composite and Adhesive
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the effect of application of bioactive glass in different protocols on the formation of dentin bridge after indirect pulp capping using resin composite with its adhesive both are containing bioactive glass.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Disease, Dental, Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bioactive Glass
Arm Type
Experimental
Arm Description
18 teeth were capped indirectly with dental adhesive containing bioactive glass applied according to the manufacturer's instructions and cured for 20 seconds and then resin composite restoration containing bioactive glass applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.
Arm Title
Light cured calcium hydroxide
Arm Type
Active Comparator
Arm Description
18 teeth were capped indirectly with light cured calcium hydroxide (control group) applied according to the manufacturer's instructions by calcium hydroxide applicator and light cured for 20 seconds then resin composite restoration was applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.
Intervention Type
Other
Intervention Name(s)
Bioactive Glass
Intervention Description
Bioactive glass was incorporated in resin composite and its adhesive
Intervention Type
Other
Intervention Name(s)
Light cured calcium hydroxide
Intervention Description
Light cured calcium hydroxide
Primary Outcome Measure Information:
Title
Change of dentine thickness
Description
Thickness in millimeters using CBCT
Time Frame
baseline, one month, 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Active carious lesion in deep dentin of molars.
Absence of cavitated lesions at the buccal or lingual surfaces as determined by clinical and radiographic examination.
Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and abnormal tooth mobility;
Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure;
The extension of the carious lesion should be such that complete caries removal would risk pulp exposure, as determined by clinical and radiographic assessment;
Absence of radiolucencies at the interradicular or periapical regions, or thickening of the periodontal spaces, that would indicate the presence of irreversible pulp pathologies or necrosis;
Absence of internal or external root resorption.
Co-operative patients approving the trial.
Exclusion Criteria:
Patients with systemic medical conditions
pregnant females
Teeth with spontaneous pain or sensitivity to percussion.
Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
Facility Information:
Facility Name
AlAzhar University, Faculty of Dentistry for Girls
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide
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