Post-operative Sensitivity in Resin Composites
1 other identifier
interventional
60
1 country
1
Brief Summary
This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
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
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2023
CompletedFirst Submitted
Initial submission to the registry
January 27, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedFebruary 6, 2024
February 1, 2024
6 months
January 27, 2024
February 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative sensitivity
Post-operative sensitivity evaluated at follow-up periods: one day, one week, two weeks and one month using Visual Analogue Scale score with the score 0( none) and score 3( severe sensitivity)
One month
Study Arms (2)
Group A (Nano-fortified Adhesive)
EXPERIMENTALTitanium dioxide nanoparticles incorporated in dentin adhesive
Group B (Adhesive without Nanoparticles)
EXPERIMENTALAdhesive without nanoparticles
Interventions
Nano-fortified dentin adhesive
Conventional adhesives without nanoparticles
Eligibility Criteria
You may qualify if:
- participants with goof general health status
- Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
- Vital and Periodontally sound teeth
You may not qualify if:
- Patient with Temporomandibular dysfunction
- History of spontaneous pain
- Endodontically treated teeth
- Patient on analgesics within the past two weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, Pakistan
Related Publications (2)
Aboelenein AZ, Riad MI, Haridy MF. Effect of a Self-Etch Adhesive Containing Nanobioglass on Postoperative Sensitivity of Posterior Composite Restorations - A Randomized Trial. Open Access Maced J Med Sci. 2019 Jul 25;7(14):2313-2320. doi: 10.3889/oamjms.2019.585. eCollection 2019 Jul 30.
PMID: 31592280BACKGROUNDAmir N, Mansoor A, Eeman N, Ahmed MN, Mansoor E, Hussain K, Palma PJ. Postoperative sensitivity of composites using novel Bacillus subtilis nanofortified adhesives: a triple-blind study. BMC Oral Health. 2024 Sep 12;24(1):1077. doi: 10.1186/s12903-024-04825-2.
PMID: 39267015DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nehal Amir, BDS
Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 27, 2024
First Posted
February 5, 2024
Study Start
May 15, 2023
Primary Completion
November 25, 2023
Study Completion
November 25, 2023
Last Updated
February 6, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share