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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
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Discoloration, Tooth focused on measuring Tooth color changes, Orthognathic surgery, Spectrophotometer

Eligibility Criteria

13 Years - 44 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 16, 2018
    Last Updated
    August 8, 2019
    Sponsor
    Aristotle University Of Thessaloniki
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    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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