Color; Change Teeth, PosteruptiveNCT04290598
Clinical Effects of Dehydration on Tooth Colour
An observational study of Color; Change Teeth, Posteruptive, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Dental restorations should mimic sound tooth structures in terms of color and optical properties especially in the anterior region. However, closely matching natural teeth with a restoration can be one of the most challenging procedure in restorative dentistry. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Color; Change Teeth, Posteruptive
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2019to 27 Dec 2019
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be selected amoung patients referring for dental treatments to Tokat Gaziosmanpasa University Faculty of Dentistry. Patients in the age range of 18-45 years and meeting inclusion criteria will be participated in this study.
Who may be able to join
- To be in the age range of 18-45 years
- Upper central and lateral incisors should have a good periodontal condition and should be sound with no wear, restorations, internal or external discoloration
Who cannot join
- Recent fixed orthodontic appliance
- Vital tooth bleaching in the last year
- Medication, affecting salivary flow or complaint of dry mouth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University Faculty of Dentistry
Tokat Province, 60100
About this study
Official title: Clinical Effects of Dehydration on Tooth Colour: How Much and How Long?
Dental restorations should mimic sound tooth structures in terms of color and optical properties especially in the anterior region. However, closely matching natural teeth with a restoration can be one of the most challenging procedure in restorative dentistry. Shade matching includes color determination, color communication with dental lab and color reproduction with dental restoration for indirect techniques or color determination and selection of the appropriate material and application method when using direct techniques. Therefore color selection is the first critical step in the restoration procedures and should be carried out properly.
Color determination must be carried out before any of the restorative procedures, isolation or impression. Most of the dental procedures cause dehydration and increase the opacity of the enamel and teeth appear whiter. Few clinical and in vitro studies evaluated the degree of color change after dehydration and rehydration periods. However, inconsistencies exist between studies in terms of color change degree and duration of return to appreciable values.
Read more
The aim of the present study was to evaluate the degree of color change in half an hour dehydration period of the teeth and to determine if color return to baseline after half an hour or 24 hours.
According to the null hypotheses of the study:
- There is no perceptible difference occur after tooth dehydration.
- Tooth color will not return to baseline values after half an hour or 24 hours rehydration periods.
Read the detailed description
Color measurements Color measurements were performed with a spectrophotometer (SpectroShade Micro, MHT Optic Research AG, Niederhasli, Switzerland) by the same experienced dentist in the present study. Spectrophotometer was calibrated and used according to manufacturer instructions before each set of measurements. All participants were asked for not to mouth breath during color measurements. All of the color measurements were carried out under standard light conditions with the aim of minimizing the possible inaccurate readings.
Dehydration procedure Spectrophotometric color measurements were performed at the study inception and baseline color parameters were recorded. Lips were retracted by using a lip and cheek retractor which placed within 10 s. Upper central and lateral incisors were isolated with cotton rolls and air dried for 5 s. Excess saliva was removed with a suction and participants keep their mouth half-opened with the help of silicone mouth bite blocks. Spectrophotometric measurements were carried out three times during 30 min with 10 min intervals during the dehydration period for each test tooth.
Rehydration procedure At the end of the dehydration procedure, lip retractor and cotton rolls were removed and full-mouth rinse with water was done for 30 s. Participants asked to drink a bottle of water and close their mouth for 30 min. Participants were asked to return to routine daily activity, but not to consume staining beverages such as coffe or red wine. Tooth rehydration process was started when test teeth get in contact with saliva. Spectrophotometric measurements were carried out at 30 min and 24 h of rehydration.
CIELAB color parameters (L*,a*,b*) were used to calculate color differences (ΔE) between baseline and other measurement periods for each tooth and gingival, middle and incisal thirds separetely. Color difference was calculated by using an equation; ΔE*=[(ΔL*)2+(Δa*)2+(Δb*)2]1/2. ΔE values were compared to threshold values of acceptability(ΔE*=3,7) and perceptibility(ΔE*=1). 11 Color difference and color parameters of 30 min and 24h dehydration was compared to baseline color parameters.
- Conditions
- Color; Change Teeth, Posteruptive
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of color change after dehydration period
CIELAB color system and L*,a*,b* parameters and delta E values
Measured: Thirty minutes dehydration period and rehydration period after 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start14 Oct 2019
- Primary completion22 Nov 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Color; Change Teeth, PosteruptiveStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huseyin Hatirli, Tokat Gaziosmanpasa University
- Investigators
- Huseyin Hatirli, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290598
- Sponsor's protocol ID
- GaziosmanpasaU2019-46
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suliman S, Sulaiman TA, Olafsson VG, Delgado AJ, Donovan TE, Heymann HO. Effect of time on tooth dehydration and rehydration. J Esthet Restor Dent. 2019 Mar;31(2):118-123. doi: 10.1111/jerd.12461. Epub 2019 Feb 23.
PubMed 30801926Burki Z, Watkins S, Wilson R, Fenlon M. A randomised controlled trial to investigate the effects of dehydration on tooth colour. J Dent. 2013 Mar;41(3):250-7. doi: 10.1016/j.jdent.2012.11.009. Epub 2012 Nov 14.
PubMed 23160038Russell MD, Gulfraz M, Moss BW. In vivo measurement of colour changes in natural teeth. J Oral Rehabil. 2000 Sep;27(9):786-92. doi: 10.1046/j.1365-2842.2000.00610.x.
PubMed 11012854
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Dehydration on Tooth Colour: How Much and How Long?
- ClinicalTrials.gov ID
- NCT04290598
- Acronym / sponsor ID
- GaziosmanpasaU2019-46
- Conditions
- Color; Change Teeth, Posteruptive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 2 Mar 2020 (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.
Dental restorations should mimic sound tooth structures in terms of color and optical properties especially in the anterior region. However, closely matching natural teeth with a restoration can be one of the most challenging procedure in restorative dentistry. Shade matching includes color determination, color communication with dental lab and color reproduction with dental restoration for indirect techniques or color determination and selection of the appropriate material and application method when using direct techniques. Therefore color selection is the first critical step in the restoration procedures and should be carried out properly.
Color determination must be carried out before any of the restorative procedures, isolation or impression. Most of the dental procedures cause dehydration and increase the opacity of the enamel and teeth appear whiter. Few clinical and in vitro studies evaluated the degree of color change after dehydration and rehydration periods. However, inconsistencies exist between studies in terms of color change degree and duration of return to appreciable values.
The aim of the present study was to evaluate the degree of color change in half an hour dehydration period of the teeth and to determine if color return to baseline after half an hour or 24 hours.
According to the null hypotheses of the study:
- There is no perceptible difference occur after tooth dehydration.
- Tooth color will not return to baseline values after half an hour or 24 hours rehydration periods.
Detailed description
Color measurements Color measurements were performed with a spectrophotometer (SpectroShade Micro, MHT Optic Research AG, Niederhasli, Switzerland) by the same experienced dentist in the present study. Spectrophotometer was calibrated and used according to manufacturer instructions before each set of measurements. All participants were asked for not to mouth breath during color measurements. All of the color measurements were carried out under standard light conditions with the aim of minimizing the possible inaccurate readings.
Dehydration procedure Spectrophotometric color measurements were performed at the study inception and baseline color parameters were recorded. Lips were retracted by using a lip and cheek retractor which placed within 10 s. Upper central and lateral incisors were isolated with cotton rolls and air dried for 5 s. Excess saliva was removed with a suction and participants keep their mouth half-opened with the help of silicone mouth bite blocks. Spectrophotometric measurements were carried out three times during 30 min with 10 min intervals during the dehydration period for each test tooth.
Rehydration procedure At the end of the dehydration procedure, lip retractor and cotton rolls were removed and full-mouth rinse with water was done for 30 s. Participants asked to drink a bottle of water and close their mouth for 30 min. Participants were asked to return to routine daily activity, but not to consume staining beverages such as coffe or red wine. Tooth rehydration process was started when test teeth get in contact with saliva. Spectrophotometric measurements were carried out at 30 min and 24 h of rehydration.
CIELAB color parameters (L*,a*,b*) were used to calculate color differences (ΔE) between baseline and other measurement periods for each tooth and gingival, middle and incisal thirds separetely. Color difference was calculated by using an equation; ΔE*=[(ΔL*)2+(Δa*)2+(Δb*)2]1/2. ΔE values were compared to threshold values of acceptability(ΔE*=3,7) and perceptibility(ΔE*=1). 11 Color difference and color parameters of 30 min and 24h dehydration was compared to baseline color parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be selected amoung patients referring for dental treatments to Tokat Gaziosmanpasa University Faculty of Dentistry. Patients in the age range of 18-45 years and meeting inclusion criteria will be participated in this study.
Key inclusion criteria (2 listed)
- To be in the age range of 18-45 years
- Upper central and lateral incisors should have a good periodontal condition and should be sound with no wear, restorations, internal or external discoloration
Key exclusion criteria (3 listed)
- Recent fixed orthodontic appliance
- Vital tooth bleaching in the last year
- Medication, affecting salivary flow or complaint of dry mouth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of color change after dehydration period
Time frame: Thirty minutes dehydration period and rehydration period after 24 hours.
CIELAB color system and L*,a*,b* parameters and delta E values
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 3 Mar 2020.
- Background: PubMed 30801926Suliman S, Sulaiman TA, Olafsson VG, Delgado AJ, Donovan TE, Heymann HO. Effect of time on tooth dehydration and rehydration. J Esthet Restor Dent. 2019 Mar;31(2):118-123. doi: 10.1111/jerd.12461. Epub 2019 Feb 23.
- Background: PubMed 23160038Burki Z, Watkins S, Wilson R, Fenlon M. A randomised controlled trial to investigate the effects of dehydration on tooth colour. J Dent. 2013 Mar;41(3):250-7. doi: 10.1016/j.jdent.2012.11.009. Epub 2012 Nov 14.
- Background: PubMed 11012854Russell MD, Gulfraz M, Moss BW. In vivo measurement of colour changes in natural teeth. J Oral Rehabil. 2000 Sep;27(9):786-92. doi: 10.1046/j.1365-2842.2000.00610.x.
- Individual participant dataSharing planned: No
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.
Huseyin Hatirli principal investigator
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Color; Change Teeth, Posteruptive, run by Tokat Gaziosmanpasa University 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?
The sponsor lists 2 inclusion and 3 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: finished, as of the sponsor's last update on 3 Mar 2020. 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?
Degree of color change after dehydration period (time frame: Thirty minutes dehydration period and rehydration period after 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290598, which also lists 3 linked publications.
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 3 Mar 2020.