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CompletedNCT07781241Updated Aug 24, 2026

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

An interventional study of Microfilled Reinforced Polyacrylic Resin Provisional Restoration and PMMA Provisional Restoration in Provisional Dental Restorations, sponsored by University of Gaziantep. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by University of Gaziantep · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Provisional Dental Restorations

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Keywords

  • CAD/CAM
  • CIEDE2000
  • Color Stability
  • Tooth Sensitivity
  • Provisional Restorations
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    VITA CAD-Temp

    Participants assigned to this arm received a CAD/CAM-milled provisional restoration fabricated from VITA CAD-Temp.

    Device: Microfilled Reinforced Polyacrylic Resin Provisional Restoration

  • Experimental
    Telio CAD

    Participants assigned to this arm received a CAD/CAM-milled provisional restoration fabricated from Telio CAD.

    Device: PMMA Provisional Restoration

  • Active comparator
    Protemp 4

    Participants assigned to this arm received a conventionally fabricated provisional restoration using Protemp 4 bis-acryl composite resin.

    Device: Bis-Acryl Composite Resin Provisional Restoration

Interventions

  • DeviceMicrofilled Reinforced Polyacrylic Resin Provisional Restoration

    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.

  • DevicePMMA Provisional Restoration

    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.

  • DeviceBis-Acryl Composite Resin Provisional Restoration

    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.

05

What researchers measure

Primary outcomes

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

    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.

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

Secondary outcomes

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

    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.

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

06

Study locations

1 site
  • Gaziantep University Faculty of Dentistry, Department of Prosthodontics
    Gaziantep, Gaziantep 27310, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No — There is no predefined plan to share de-identified individual participant data (IPD). However, data supporting the findings of the study may be made available from the corresponding author upon reasonable request, subject to applicable ethical and institutional requirements.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07781241
Lead sponsor
University of Gaziantep
Responsible party
Gökçe Keçeci (Assistant Professor, University of Gaziantep) — Principal investigator
First posted
Aug 24, 2026
Start date
Jan 3, 2023
Primary completion
Jun 10, 2023
Completion
Jun 10, 2023
Last update
Aug 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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