Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-50
SponsorCairo University

About this trial

this study aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. the clinical performance assessed include marginal adaptation primarily and in addition to Color match, marginal discoloration, aesthetic anatomic form, recurrent caries and restoration fracture and post-operative hypersensitivity. the clinical performance will be assessed after the restoration cementation, after 6, 12, 18 and 24 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Systematically healthy male or female subjects aged 16 to 50 years.

Patients with good oral hygiene.

Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.

Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.

Disqualifiers

Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).

Current pregnancy or lactation.

Documented allergy to resin-based composites or adhesive systems.

Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.

Trial design

Design model

Parallel

Treatments tested in this trial

  • hybrid ceramics

    Other intervention

    after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Hard Hybrid Ceramic Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds. SHOFU HC Primer will be applied to the hybrid-ceramic group.

  • Composite resin

    Other intervention

    after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Composite Resin Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Hybrid ceramic groupExperimental treatment 1 intervention
Group B: Composite Resin groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Marginal Adaptation

measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

Time frame
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

Secondary outcomes

1

color match

measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

Time frame
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
2

marginal discoloration

measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

Time frame
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
3

aesthetic anatomic form

measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

Time frame
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
4

recurrent caries

measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

Time frame
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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