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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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ClinicalTrials.gov Identifier: NCT04274920
Recruitment Status : Completed
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Heba Arafa Abd El wahab Zahran, Al-Azhar University

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.

Condition or disease Intervention/treatment Phase
Pulp Disease, Dental Dental Caries Other: Bioactive Glass Other: Light cured calcium hydroxide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Response of Human Pulps Capped With Bioactive Glass Incorporated in Resin Composite and Adhesive
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Eye Wear

Arm Intervention/treatment
Experimental: Bioactive Glass
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.
Other: Bioactive Glass
Bioactive glass was incorporated in resin composite and its adhesive

Active Comparator: Light cured calcium hydroxide
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.
Other: Light cured calcium hydroxide
Light cured calcium hydroxide




Primary Outcome Measures :
  1. Change of dentine thickness [ Time Frame: baseline, one month, 3 months and 6 months ]
    Thickness in millimeters using CBCT



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274920


Locations
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Egypt
AlAzhar University, Faculty of Dentistry for Girls
Cairo, Egypt
Sponsors and Collaborators
Al-Azhar University

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Responsible Party: Heba Arafa Abd El wahab Zahran, Principal Investigator, Al-Azhar University
ClinicalTrials.gov Identifier: NCT04274920    
Other Study ID Numbers: REC16-071
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Dental Pulp Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Calcium, Dietary
Methamphetamine
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors