Restoration of Non-carious Cervical Lesions With Different Resin Composites and Universal Adhesive
1 other identifier
interventional
52
1 country
1
Brief Summary
patients with non carious cervical lesions suffer from dentin sensitivity and presence of cavitations and gingival recession. Restoring these lesions with different composites and evaluation of restorations every 6 months will be done to know the effect of different composite types and consistencies in retention of restorations of such lesions.
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 2022
Longer than P75 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 14, 2022
CompletedFirst Submitted
Initial submission to the registry
August 29, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
ExpectedFebruary 27, 2025
February 1, 2025
3.6 years
August 29, 2023
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Retention
ability of resin composite restorations to be retained in the non carious cervical lesions
18-24 months
Secondary Outcomes (1)
marginal staining
18-24 months
Other Outcomes (2)
Marginal adaptation
18-24 months
postoperative sensitivity
18-24 months
Study Arms (4)
incremental
EXPERIMENTALapplication of increments of packable composite in non carious cervical lesions
bulk fill heated
EXPERIMENTALapplication of heated composite as bulk in the lesions without incrementation after heating with caps warmer
incremental heated
EXPERIMENTALapplication of composite in increments after being heated by caps warmer
flowable
EXPERIMENTALapplication of flowable composite in non carious cervical lesions
Interventions
different types of resin composite restorations will be used to restore NCCL
Eligibility Criteria
You may qualify if:
- \- Patients' age will range from 18 to 65 years.
- Presence of at least 2 NCCLs in one side.
- Patients with no medical condition could interfere with the routine dental care.
- Patients who will be able to attend for each recall visit.
- Patients with healthy periodontal tissues.
- Cavities presenting no more than 50% of margins in enamel.
You may not qualify if:
- Medically compromised patients.
- Pregnant or breast-feeding patients.
- Patients undergoing orthodontic treatment or bleaching treatment in the time of the study.
- Patients with periodontal disease in the target area.
- Patients presented with less than 20 teeth in the oral cavity.
- Patients without antagonists.
- Lesions superimposed with caries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain shams university
Cairo, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
August 29, 2023
First Posted
May 1, 2024
Study Start
May 14, 2022
Primary Completion
December 14, 2025
Study Completion (Estimated)
December 30, 2026
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- expecting to have all data by october 2026