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Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin

Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05614076
Enrollment
34
Registered
2022-11-14
Start date
2021-11-04
Completion date
2023-05-31
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class V Dental Caries

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

Interventions

PROCEDUREconserved chalky white enamel margins of class V cavities

during cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria

PROCEDURETotal removal of demineralized enamel margins of class V cavities

during cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participant and Outcomes Assessor

Intervention model description

1:1

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
marginal discoloration3 monthsordinal criteria scoring system (ordinal)

Secondary

MeasureTime frameDescription
color change3 monthordinal criteria scoring system (ordinal)

Countries

Egypt

Contacts

Primary ContactMaryam Salim Dawood, master
maryam.salim@dentistry.cu.edu.eg00201011270500
Backup ContactMohamed Refaat El-Bialy, PHD
mohamed.refaat@dentistry.cu.edu.eg00201202552666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026