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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04290598
Other study ID # GaziosmanpasaU2019-46
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 14, 2019
Est. completion date December 27, 2019

Study information

Verified date February 2020
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 27, 2019
Est. primary completion date November 22, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Recent fixed orthodontic appliance

- Vital tooth bleaching in the last year

- Medication, affecting salivary flow or complaint of dry mouth

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Tokat Gaziosmanpasa University Faculty of Dentistry Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Burki 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. — View Citation

Russell MD, Gulfraz M, Moss BW. In vivo measurement of colour changes in natural teeth. J Oral Rehabil. 2000 Sep;27(9):786-92. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of color change after dehydration period CIELAB color system and L*,a*,b* parameters and delta E values Thirty minutes dehydration period and rehydration period after 24 hours.
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