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Completed

NCT Number: NCT07781241

Color Stability and Tooth Sensitivity of CAD/CAM and Conventional Provisional Restorations

This prospective randomized clinical study compared the color stability and postoperative tooth sensitivity of provisional restorations fabricated using two CAD/CAM-milled materials (VITA CAD-Temp and Telio CAD) and a conventionally fabricated bis-acryl composite resin (Protemp 4) in patients undergoing fixed prosthodontic treatment. Forty-five participants were randomly allocated in a 1:1:1 ratio to the three provisional restorative material groups, with one restoration evaluated per participant. Color was measured spectrophotometrically at baseline, 2 weeks, 1 month, 2 months, and 3 months, and color change was calculated using the CIEDE2000 formula. Tooth sensitivity was assessed using a 0-10 visual analog scale before treatment, immediately after placement of the provisional restoration, and at 2 weeks, 1 month, 2 months, and 3 months. The study aimed to determine whether these provisional restorative material-workflow combinations differed in longitudinal color stability and postoperative tooth sensitivity during the 3-month clinical follow-up.

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Key information

Conditions

Provisional Dental Restorations Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziantep University Faculty of Dentistry, Department of Prosthodontics

Gaziantep, 27310, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 to 70 years Requiring fixed prosthodontic treatment Presence of a vital tooth without previous endodontic treatment Good oral hygiene Non-smoker No uncontrolled parafunctional habits -

Exclusion criteria

High caries risk Generalized gingival inflammation Periodontitis Poor oral hygiene Severe spontaneous dental pain Pregnancy Oncologic disorders Psychiatric disorders

-

Treatment and study plan

Microfilled Reinforced Polyacrylic Resin Provisional Restoration

Device

A provisional fixed restoration was digitally designed and CAD/CAM-milled from a prefabricated VITA CAD-Temp microfilled reinforced polyacrylic resin block. The restoration was finished and polished according to the manufacturer's recommendations, clinically adjusted as needed, and cemented with Temp-Bond Clear temporary resin cement.

PMMA Provisional Restoration

Device

A provisional fixed restoration was digitally designed and CAD/CAM-milled from a prefabricated Telio CAD PMMA block. The restoration was finished and polished according to the manufacturer's recommendations, clinically adjusted as needed, and cemented with Temp-Bond Clear temporary resin cement.

Bis-Acryl Composite Resin Provisional Restoration

Device

A provisional fixed restoration was conventionally fabricated using Protemp 4 bis-acryl composite resin with a silicone index. The restoration was finished and polished according to the manufacturer's recommendations, clinically adjusted as needed, and cemented with Temp-Bond Clear temporary resin cement.

Primary outcomes

  1. Color Change of Provisional Restorations Measured by CIEDE2000 (ΔE00)

    Time frame: Baseline to 2 weeks, 1 month, 2 months, and 3 months

    Color was measured using a VITA Easyshade spectrophotometer under standardized clinical conditions. Five consecutive measurements were obtained for each provisional restoration at each assessment, and the mean color coordinates were used. Color change relative to baseline was calculated using the CIEDE2000 color-difference formula (ΔE00). Higher ΔE00 values indicate greater color change.

Secondary outcomes

  1. Tooth Sensitivity Measured by Visual Analog Scale (VAS)

    Time frame: Before treatment, immediately after provisional restoration placement, 2 weeks, 1 month, 2 months, and 3 months

    Tooth sensitivity was assessed using a 0-10 visual analog scale (VAS), where 0 indicated no pain and 10 indicated unbearable pain. A standardized air stimulus was applied to the treated tooth from approximately 1 cm for a maximum of 3 seconds, and participants rated the intensity of sensitivity immediately after stimulation. Higher VAS scores indicate greater tooth sensitivity.

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

Clinical Color Stability and Tooth Sensitivity of CAD/CAM-Milled and Conventionally Fabricated Provisional Restorations: A Prospective Randomized Clinical Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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