Tooth ColorNCT03544658
Intervening Factors in Tooth Color Assessment
A study testing Dental prophylaxis, Tooth color assessment by the participant and Tooth color assessment by the investigator in people with Tooth Color, run by Grupo de Investigação em Bioquímica e Biologia Oral at 1 site in Portugal.
Trial summary
The aim of this study is to evaluate the influence of several factors (light, extrinsic stain removal and operator's experience) in tooth color assessment. Tooth color will be assessed by two different operators with visual shade guides under standardized light conditions and using a light correcting device (Smile… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Color
- What is being tested?
- Dental prophylaxis, Tooth color assessment by the participant and Tooth color assessment by the investigator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2018to 30 Jul 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capability to sign the informed consent
- Presence of upper teeth canines and central incisors, free of tooth decay, dental fillings, endodontic treatment or fixed rehabilitation
- Tooth color at least A3 in one of the included teeth
- Teeth should be possible to be subject to tooth color assessment with the predefined methods (color within the visual shade guides range)
- Absence of fixed orthodontic appliances or severe tooth structure anomalies
Who cannot join
- Pregnant patients
- Patients subjected to professional dental prophylaxis in less than 4 months
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculdade de Medicina Dentária, Universidade de Lisboa
Lisbon, 1600-277
Daniela C Corado, DDS
Duarte N Marques, PhD, DDS
About this study
The aim of this study is to evaluate the influence of several factors (light, extrinsic stain removal and operator's experience) in tooth color assessment. Tooth color will be assessed by two different operators with visual shade guides under standardized light conditions and using a light correcting device (Smile Lite) or with a dental spectrophotometer in human subjects. Color measurement will be made before and 1 week after dental prophylaxis.
- Conditions
- Tooth Color
- Being tested
- Dental prophylaxis, Tooth color assessment by the participant, Tooth color assessment by the investigator, Tooth color assessment with SpectroShade
- Keywords
- Tooth extrinsic stain, Tooth color, Dental prophylaxis, Visual shade guide, Dental spectrophotometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental prophylaxisProcedure or surgery
Professional dental prophylaxis including dental scaling and dental polishing with prophylactic paste
Tooth color assessment by the participantProcedure or surgery
Tooth color assessment using the VITA Classical shade guide. Assessment will be done with normal light conditions and with a light correcting device
Tooth color assessment by the investigatorProcedure or surgery
Tooth color assessment using the VITA Classical shade guide and the VITA Toothguide 3D Master. Assessment will be done with normal light conditions and with a light correcting device
Tooth color assessment with SpectroShadeProcedure or surgery
Tooth color assessment using SpectroShade (dental spectrophotometer). Color will be registered in VITA Classical and VITA Toothguide 3D Master and CIELab parameters
| Study group | Role | What they receive |
|---|---|---|
| Dental prophylaxis | Experimental | Visit 1: tooth color assessment (by patient, dentist and spectrophotometer) and professional dental prophylaxis Visit 2: tooth color assessment (by patient, dentist and spectrophotometer) Receives: Procedure: Dental prophylaxis; Procedure: Tooth color assessment by the participant; Procedure: Tooth color assessment by the investigator; Procedure: Tooth color assessment with SpectroShade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color change determined before and after professional dental prophylaxis, assessed with visual shade guide (VITA Classical)
Tooth color will be determined prior to dental prophylaxis by the participant, investigator and spectrophotometer, using visual shade guide VITA Classical. 1 week after the intervention, the tooth color will be determined once again with the same protocol.
Measured: 1 week (measurements before and 1 week after dental prophylaxis)
Tooth color change measured before and after professional dental prophylaxis, assessed with visual shade guide (VITA Toothguide 3D-Master)
Tooth color will be determined prior to dental prophylaxis by the investigator and dental spectrophotometer, using visual shade guide VITA Toothguide 3D-Master. 1 week after the intervention, the tooth color will be determined once again with the same protocol.
Measured: 1 week (measurements before and 1 week after dental prophylaxis)
Tooth color change in CIELab system measured before and after professional dental prophylaxis
Tooth color in CIELab system will be determined by the conversion of VITA Classical shade guides in CIELab parameters assessed by the participant and investigator and by the spectroshade prior to professional dental prophylaxis. 1 week after the procedure tooth color will be determined once again with the same protocol.
Measured: 1 week (measurements before and 1 week after dental prophylaxis)
Secondary outcomes (2)
Agreement between operators in tooth color assessment with visual shade guides
Comparison of tooth colors determined by the participant, investigator and spectrophotometer.
Measured: Sequencial; repeated before and 1 week after intervention
Influence of light conditions in tooth color assessment - change between determination with and without a light correcting device
Tooth color determined by the participant and investigator with visual shade guides with two different light conditions: environmental light and assessment with a light correcting device (Smile Lite)
Measured: Sequencial; repeated before and 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Jun 2018 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ColorStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigação em Bioquímica e Biologia Oral
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lisbon
- Responsible party
- Sponsor
- Investigators
- Duarte S Marques, PhD, DDS, Study director, Grupo de Investigação em Bioquímica e Biologia Oral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544658
- Sponsor's protocol ID
- BL 16000
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening Factors in Tooth Color Assessment
- ClinicalTrials.gov ID
- NCT03544658
- Acronym / sponsor ID
- BL 16000
- Conditions
- Tooth Color
- Keywords
- Tooth extrinsic stain, Tooth color, Dental prophylaxis, Visual shade guide, Dental spectrophotometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Grupo de Investigação em Bioquímica e Biologia OralUniversity, hospital or other
- Collaborators
- University of Lisbon
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 4 Jun 2018 (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.
The aim of this study is to evaluate the influence of several factors (light, extrinsic stain removal and operator's experience) in tooth color assessment. Tooth color will be assessed by two different operators with visual shade guides under standardized light conditions and using a light correcting device (Smile Lite) or with a dental spectrophotometer in human subjects. Color measurement will be made before and 1 week after dental prophylaxis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental prophylaxis | Experimental | Procedure: Dental prophylaxis, Procedure: Tooth color assessment by the participant, Procedure: Tooth color assessment by the investigator, Procedure: Tooth color assessment with SpectroShadeVisit 1: tooth color assessment (by patient, dentist and spectrophotometer) and professional dental prophylaxis Visit 2: tooth color assessment (by patient, dentist and spectrophotometer) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capability to sign the informed consent
- Presence of upper teeth canines and central incisors, free of tooth decay, dental fillings, endodontic treatment or fixed rehabilitation
- Tooth color at least A3 in one of the included teeth
- Teeth should be possible to be subject to tooth color assessment with the predefined methods (color within the visual shade guides range)
- Absence of fixed orthodontic appliances or severe tooth structure anomalies
Key exclusion criteria (2 listed)
- Pregnant patients
- Patients subjected to professional dental prophylaxis in less than 4 months
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 |
|---|---|---|
| Dental prophylaxisProfessional dental prophylaxis including dental scaling and dental polishing with prophylactic paste | Procedure or surgery | Dental prophylaxis |
| Tooth color assessment by the participantTooth color assessment using the VITA Classical shade guide. Assessment will be done with normal light conditions and with a light correcting device | Procedure or surgery | Dental prophylaxis |
| Tooth color assessment by the investigatorTooth color assessment using the VITA Classical shade guide and the VITA Toothguide 3D Master. Assessment will be done with normal light conditions and with a light correcting device | Procedure or surgery | Dental prophylaxis |
| Tooth color assessment with SpectroShadeTooth color assessment using SpectroShade (dental spectrophotometer). Color will be registered in VITA Classical and VITA Toothguide 3D Master and CIELab parameters | Procedure or surgery | Dental prophylaxis |
Primary outcome
Tooth color change determined before and after professional dental prophylaxis, assessed with visual shade guide (VITA Classical)
Time frame: 1 week (measurements before and 1 week after dental prophylaxis)
Tooth color will be determined prior to dental prophylaxis by the participant, investigator and spectrophotometer, using visual shade guide VITA Classical. 1 week after the intervention, the tooth color will be determined once again with the same protocol.
Tooth color change measured before and after professional dental prophylaxis, assessed with visual shade guide (VITA Toothguide 3D-Master)
Time frame: 1 week (measurements before and 1 week after dental prophylaxis)
Tooth color will be determined prior to dental prophylaxis by the investigator and dental spectrophotometer, using visual shade guide VITA Toothguide 3D-Master. 1 week after the intervention, the tooth color will be determined once again with the same protocol.
Tooth color change in CIELab system measured before and after professional dental prophylaxis
Time frame: 1 week (measurements before and 1 week after dental prophylaxis)
Tooth color in CIELab system will be determined by the conversion of VITA Classical shade guides in CIELab parameters assessed by the participant and investigator and by the spectroshade prior to professional dental prophylaxis. 1 week after the procedure tooth color will be determined once again with the same protocol.
2 secondary outcomes
Agreement between operators in tooth color assessment with visual shade guides
Time frame: Sequencial; repeated before and 1 week after intervention
Influence of light conditions in tooth color assessment - change between determination with and without a light correcting device
Time frame: Sequencial; repeated before and 1 week after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
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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.
Duarte S Marques, PhD, DDS study director
Grupo de Investigação em Bioquímica e Biologia Oral
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental prophylaxis, Tooth color assessment by the participant and Tooth color assessment by the investigator in people with Tooth Color, run by Grupo de Investigação em Bioquímica e Biologia Oral at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 4 Jun 2018. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela C Corado, DDS ((+351) 912388159, daniela-corado@campus.ul.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth color change determined before and after professional dental prophylaxis, assessed with visual shade guide (VITA Classical) (time frame: 1 week (measurements before and 1 week after dental prophylaxis)). The study lists 3 primary outcomes in all. 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 4 Jun 2018.