In Vivo Assessment of Natural Tooth Color After Orthognathic Surgery. A Pilot Controlled Clinical Trial
Primary Purpose
Discoloration, Tooth
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined orthodontic-orthognathic treatment
Standard orthodontic treatment
Sponsored by
About this trial
This is an interventional screening trial for Discoloration, Tooth focused on measuring Tooth color changes, Orthognathic surgery, Spectrophotometer
Eligibility Criteria
Inclusion Criteria:
- Absence of plaque accumulation and gingival inflammation. The Haemorrhagic index and Plaque index should be lower than 15 %.
- Absence of dental caries, prosthetic restorations, decalcifications, intrinsic and ⁄ or extrinsic discolorations, as well as morphologic ⁄ anatomical deviations in the measured teeth.
- Absence of severe crowding in the upper and lower dental arches (crowding should be lower than 4 mm).
Exclusion Criteria:
- Previous orthodontic treatment
- smoking
- previous bleaching procedure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Active Comparator
Arm Label
Study group
Control Group I
Control Group II
Arm Description
Combined orthodontic-orthognathic treatment
No intervention
Standard orthodontic treatment
Outcomes
Primary Outcome Measures
Tooth color parameter L* change
Lightness parameter of CIE-L*a*b* system
Tooth color parameter a* change
Green-red component of CIE-L*a*b* system
Tooth color parameter b* change
Blue-Yellow component of CIE-L*a*b* system
Secondary Outcome Measures
Full Information
NCT ID
NCT03657498
First Posted
July 16, 2018
Last Updated
August 8, 2019
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT03657498
Brief Title
In Vivo Assessment of Natural Tooth Color After Orthognathic Surgery. A Pilot Controlled Clinical Trial
Official Title
In Vivo Assessment of Natural Tooth Color, Pulp Vitality and Root Morphology After Combined Orthodontic-orthognathic Surgery Involving Maxillary Le Fort I Osteotomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2010 (Actual)
Primary Completion Date
February 2, 2017 (Actual)
Study Completion Date
February 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In six consecutive patients planned to receive combined orthodontic-orthognathic surgery natural tooth color on 8 incisors was measured before initiation of the combined treatment (Time Point 1- baseline) and after its completion (Time Point 2- after intervention). The statistical interpretation of the results showed that tooth color change in the surgical group was higher in comparison to control groups. Control group I included non treatment subjects, while control group II included standard orthodontic treatment subjects. The results indicated that orthognathic surgery may affect natural tooth color but to small degree, as the color differences were just bellow the threshold value of 3.7 ΔΕ units. Under this value a color change cannot be easily detected by a human eye.
Detailed Description
The method of natural tooth color assessment included the use of the spectrophotometer Spectroshade Micro (MHT Zurich, Switzerland), which is a reflectance spectrophotometer with a LED technology light source with an output of 410-680 nm that is transformed into monochromatic light (λ = 400-720 nm) by means of grating. On this type of spectrophotometers, light is split so that teeth can be illuminated simultaneously from two sides at a 45° angle with the use of an intra-oral camera. The reflected light is directed at 0° on two detector areas (each detector area surface is of 18 x 13 mm2). One detector area is a color CCD chip responsible for the generation of the colored video image. A black-and-white CCD detector area records the spectrophotometric data. During a measuring process, light originating from the monochromator of the device is emitted in 10-nm intervals. Resulting images consist of 300,000 pixels. Initially, CIE tristimulus values are calculated and then converted to CIE-Lab values with the use of the accompanying software. Prior to every measuring cycle, the spectrophotometer had to be calibrated to a white and a green ceramic tile that are incorporated on the base of the device by the manufacturer.
Assessments were performed with closed lips in order to exclude disturbance by daylight. In order to avoid methodical errors in the assessment of luminance teeth of the upper and lower dental arches were not in contact, thereby obtaining a uniform black background by the oral cavity without an overlapping of anterior teeth. Tooth color was measured in the study and in the control groups at Time point 1 and Time Point 2. To enhance reliability of the method two sequential pictures of each tooth (Left + Right) were obtained with the use of the spectrophotometer and imported to the dedicated MHT Spectroshade software v3.01 Build 1007a (MHT Zurich, Switzerland), licensed to Aristotle University (Station ID: 952317337-Serial NR LUA164-164-164). Using the synchronization tool followed by the synchronous measurement tool, the cursor was accurately positioned on the center of the clinical crown on both pictures simultaneously, and the software reported color measurements for both pictures. The cursor shape was a circle, while the size was set at 100 pixels. Due to the synchronization of the pictures, the cursor area was exactly the same for both. To consider the method reliable, the maximal allowed color difference between the two consecutive pictures, was set at ΔΕ≤1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoloration, Tooth
Keywords
Tooth color changes, Orthognathic surgery, Spectrophotometer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The trial includes a study group of patients receiving orthognathic surgery. It is divided into two subgroups. Subgroup I including bimaxillary surgical patients with Le-Fort I osteotomy for the upper jaw and sagittal split ramus osteotomy for the lower jaw. Subgroup II including patients receiving mandibular surgery only. Finally, two control groups were applied. Control group I including no treatment subjects and Control group II including standard orthodontic treatment subjects
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Combined orthodontic-orthognathic treatment
Arm Title
Control Group I
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Control Group II
Arm Type
Active Comparator
Arm Description
Standard orthodontic treatment
Intervention Type
Procedure
Intervention Name(s)
Combined orthodontic-orthognathic treatment
Intervention Description
combined treatment including orthodontics and orthognathic surgery
Intervention Type
Procedure
Intervention Name(s)
Standard orthodontic treatment
Intervention Description
treatment with standard orthodontic procedures
Primary Outcome Measure Information:
Title
Tooth color parameter L* change
Description
Lightness parameter of CIE-L*a*b* system
Time Frame
Up to 49 months
Title
Tooth color parameter a* change
Description
Green-red component of CIE-L*a*b* system
Time Frame
Up to 49 months
Title
Tooth color parameter b* change
Description
Blue-Yellow component of CIE-L*a*b* system
Time Frame
Up to 49 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Absence of plaque accumulation and gingival inflammation. The Haemorrhagic index and Plaque index should be lower than 15 %.
Absence of dental caries, prosthetic restorations, decalcifications, intrinsic and ⁄ or extrinsic discolorations, as well as morphologic ⁄ anatomical deviations in the measured teeth.
Absence of severe crowding in the upper and lower dental arches (crowding should be lower than 4 mm).
Exclusion Criteria:
Previous orthodontic treatment
smoking
previous bleaching procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Lazaridis, Dr
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21055582
Citation
Karamouzos A, Athanasiou AE, Papadopoulos MA, Kolokithas G. Tooth-color assessment after orthodontic treatment: a prospective clinical trial. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):537.e1-8; discussion 537-9. doi: 10.1016/j.ajodo.2010.03.026.
Results Reference
result
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In Vivo Assessment of Natural Tooth Color After Orthognathic Surgery. A Pilot Controlled Clinical Trial
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