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

NCT07781241 | Completed

• 2 other identifiers: 2021/320DHF.UT.22.08
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Provisional Dental Restorations

Keywords

CAD/CAM; CIEDE2000; Color Stability; Tooth Sensitivity; Provisional Restorations

Outcome Measures

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.

  Baseline to 2 weeks, 1 month, 2 months, and 3 months

Secondary Outcomes (1)

• Tooth Sensitivity Measured by Visual Analog Scale (VAS)

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

Study Arms (3)

VITA CAD-Temp

EXPERIMENTAL

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

Device: Microfilled Reinforced Polyacrylic Resin Provisional Restoration

Telio CAD

EXPERIMENTAL

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

Device: PMMA Provisional Restoration

Protemp 4

ACTIVE COMPARATOR

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

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.

VITA CAD-Temp

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.

Telio CAD

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.

Protemp 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University Faculty of Dentistry, Department of Prosthodontics

Gaziantep, Gaziantep, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned in a 1:1:1 ratio to three parallel groups according to the provisional restorative material used: VITA CAD-Temp, Telio CAD, or Protemp 4.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: January 3, 2023
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)