Clinical trial NCT05614076: Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin
Official title: Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class V Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1
Primary purpose: TREATMENT

Brief summary: This study aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions

Detailed description: With limited evidence-based information about the clinical performance of conserved white chalky enamel margins in class v .it is beneficial to compare the newly concept of preserved the white chalky deminerlized enamel margins using a randomized clinical trial to test the null hypothesis that this new concept has the same clinical performance as total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions .The comparator will be the concept of total removal of demineralized enamel margins in class v cavities restored with composite Patients are selected according to the eligibility criteria, Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For the comparator group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For interventional group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For control group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For experimental group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. both cavities groups restored with resin composite restorations. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures

Eligibility criteria: Inclusion Criteria:

* class V carious lesions in premolars and molars.
* Vital upper or lower teeth with no signs of irreversible pulpitis.
* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria:

* Deep carious defects (close to pulp, less than 1 mm distance).
* Periapical pathology or signs of pulpal pathology.
* Endodontically treated teeth
* Tooth hypersensitivity.
* Possible prosthodontic restoration of teeth.
* Heavy occlusion or occlusal contacts or history of bruxism.
* Severe periodontal affection

Primary outcomes:
measure: marginal discoloration
timeFrame: 3 months
measure: marginal discoloration
timeFrame: 6 months
measure: marginal discoloration
timeFrame: 12 months
Secondary outcomes:
measure: color change
timeFrame: 3 month
measure: color change
timeFrame: 6 month
measure: color change
timeFrame: 12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo University
Study officials:
References:
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