Provisional Dental RestorationsNCT07781241
Color Stability and Tooth Sensitivity of CAD/CAM and Conventional Provisional Restorations
A study testing Microfilled Reinforced Polyacrylic Resin Provisional Restoration, PMMA Provisional Restoration and Bis-Acryl Composite Resin Provisional Restoration in people with Provisional Dental Restorations, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Provisional Dental Restorations
- What is being tested?
- Microfilled Reinforced Polyacrylic Resin Provisional Restoration, PMMA Provisional Restoration and Bis-Acryl Composite Resin Provisional Restoration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2023to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Faculty of Dentistry, Department of Prosthodontics
Gaziantep, Gaziantep, 27310
About this study
Official title: Clinical Color Stability and Tooth Sensitivity of CAD/CAM-Milled and Conventionally Fabricated Provisional Restorations: A Prospective Randomized Clinical Study
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
- Being tested
- Microfilled Reinforced Polyacrylic Resin Provisional Restoration, PMMA Provisional Restoration, Bis-Acryl Composite Resin Provisional Restoration
- Keywords
- CAD/CAM, CIEDE2000, Color Stability, Tooth Sensitivity, Provisional Restorations
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfilled Reinforced Polyacrylic Resin Provisional RestorationDevice
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 RestorationDevice
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 RestorationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VITA CAD-Temp | Experimental | Participants assigned to this arm received a CAD/CAM-milled provisional restoration fabricated from VITA CAD-Temp. Receives: 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. Receives: 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. Receives: Device: Bis-Acryl Composite Resin Provisional Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before treatment, immediately after provisional restoration placement, 2 weeks, 1 month, 2 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start3 Jan 2023
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provisional Dental RestorationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökçe Keçeci, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781241
- Sponsor's protocol ID
- 2021/320
- Other IDs
- DHF.UT.22.08
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Color Stability and Tooth Sensitivity of CAD/CAM-Milled and Conventionally Fabricated Provisional Restorations: A Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07781241
- Acronym / sponsor ID
- 2021/320
- Conditions
- Provisional Dental Restorations
- Keywords
- CAD/CAM, CIEDE2000, Color Stability, Tooth Sensitivity, Provisional Restorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VITA CAD-Temp | Experimental | Device: Microfilled Reinforced Polyacrylic Resin Provisional RestorationParticipants assigned to this arm received a CAD/CAM-milled provisional restoration fabricated from VITA CAD-Temp. |
| Telio CAD | Experimental | Device: PMMA Provisional RestorationParticipants assigned to this arm received a CAD/CAM-milled provisional restoration fabricated from Telio CAD. |
| Protemp 4 | Active comparator | Device: Bis-Acryl Composite Resin Provisional RestorationParticipants assigned to this arm received a conventionally fabricated provisional restoration using Protemp 4 bis-acryl composite resin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfilled Reinforced Polyacrylic Resin Provisional RestorationA 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. | Device | VITA CAD-Temp |
| PMMA Provisional RestorationA 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. | Device | Telio CAD |
| Bis-Acryl Composite Resin Provisional RestorationA 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. | Device | Protemp 4 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfilled Reinforced Polyacrylic Resin Provisional Restoration, PMMA Provisional Restoration and Bis-Acryl Composite Resin Provisional Restoration in people with Provisional Dental Restorations, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color Change of Provisional Restorations Measured by CIEDE2000 (ΔE00) (time frame: Baseline to 2 weeks, 1 month, 2 months, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.