The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration
1 other identifier
interventional
10
1 country
1
Brief Summary
This study aims to investigate the influence of desensitizing agents on reducing post-operative sensitivity in posterior composite.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedFirst Submitted
Initial submission to the registry
October 27, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedNovember 2, 2023
October 1, 2023
1.1 years
October 27, 2023
October 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Hypersensitivity assessment
Air spray will be applied from a 2-mm distance on to the occlusal for 3 seconds. The severity of patients' pain/sensitivity will be recorded using (0-10) numerical rating scale. The score will be ranged from 0 (No pain) to 10 (maximum pain)
up to 12 months
Study Arms (3)
Composite with Hurriseal desensitizer
EXPERIMENTALComposite with Gluma Desensitizer
ACTIVE COMPARATORComposite without desensitizer
NO INTERVENTIONInterventions
Patients will receive Hurriseal desensitizing agent and universal bond and composite. Cavities will be restored with light-cured composite resin following the application of bonding agent.
Patients will receive Gluma desensitizing agent and universal bond and composite. Cavities will be restored with light-cured composite resin following the application of bonding agent.
Eligibility Criteria
You may qualify if:
- Patients having active primary class I carious lesions on vital molar teeth either in the middle or the inner third of dentin in the three quadrants of each patients.
- Teeth having a positive reaction to vitality test (cold test), no signs of pulp inflammation, or spontaneous pain before treatment.
- Preoperative radiographic record of the carious lesions.
- Buccolingual width is no more than half the inter-cuspal distance
You may not qualify if:
- Excessive tooth wear due to clenching or abnormal habits.
- Patients with direct occlusal contact by antagonist cusp (traumatic occlusion).
- Patients with periodontal or gingival disease.
- Patients using analgesics and/or anti-inflammatory medicine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nourhan M.Alylead
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nessrin Magdy, BDS
Alexandria University
- STUDY DIRECTOR
Waleed El-Mahy, PhD
Alexandria University
- STUDY CHAIR
Rania R Afifi, PhD
Alexandria University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Lecturer of Dental Public Health
Study Record Dates
First Submitted
October 27, 2023
First Posted
November 2, 2023
Study Start
July 5, 2022
Primary Completion
August 5, 2023
Study Completion
August 30, 2023
Last Updated
November 2, 2023
Record last verified: 2023-10