Discoloration, ToothNCT03657498
In Vivo Assessment of Natural Tooth Color After Orthognathic Surgery. A Pilot Controlled Clinical Trial
A study testing Combined orthodontic-orthognathic treatment and Standard orthodontic treatment in people with Discoloration, Tooth, run by Aristotle University Of Thessaloniki.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoloration, Tooth
- What is being tested?
- Combined orthodontic-orthognathic treatment and Standard orthodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2010to 2 Feb 2017
- 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 13 to 44 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Previous orthodontic treatment
- smoking
- previous bleaching procedure
About this study
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
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.
Read the 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.
- Conditions
- Discoloration, Tooth
- Being tested
- Combined orthodontic-orthognathic treatment, Standard orthodontic treatment
- Keywords
- Tooth color changes, Orthognathic surgery, Spectrophotometer
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined orthodontic-orthognathic treatmentProcedure or surgery
combined treatment including orthodontics and orthognathic surgery
Standard orthodontic treatmentProcedure or surgery
treatment with standard orthodontic procedures
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Combined orthodontic-orthognathic treatment Receives: Procedure: Combined orthodontic-orthognathic treatment |
| Control Group I | No intervention | No intervention |
| Control Group II | Active comparator | Standard orthodontic treatment Receives: Procedure: Standard orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color parameter L* change
Lightness parameter of CIE-L*a*b* system
Measured: Up to 49 months
Tooth color parameter a* change
Green-red component of CIE-L*a*b* system
Measured: Up to 49 months
Tooth color parameter b* change
Blue-Yellow component of CIE-L*a*b* system
Measured: Up to 49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start2 Nov 2010
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Discoloration, ToothStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Lazaridis, Aristotle University Of Thessaloniki
- Investigators
- Konstantinos Lazaridis, Dr, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657498
- Sponsor's protocol ID
- 264/02.11.2010
- Status last verified
- Aug 2019
- First submitted
- 16 Jul 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21055582
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03657498
- Acronym / sponsor ID
- 264/02.11.2010
- Conditions
- Discoloration, Tooth
- Keywords
- Tooth color changes, Orthognathic surgery, Spectrophotometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 2 Nov 2010 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 5 Sep 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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Combined orthodontic-orthognathic treatmentCombined orthodontic-orthognathic treatment |
| Control Group I | No intervention | –No intervention |
| Control Group II | Active comparator | Procedure: Standard orthodontic treatmentStandard orthodontic treatment |
Who may qualify
- Ages
- 13 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Previous orthodontic treatment
- smoking
- previous bleaching procedure
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 |
|---|---|---|
| Combined orthodontic-orthognathic treatmentcombined treatment including orthodontics and orthognathic surgery | Procedure or surgery | Study group |
| Standard orthodontic treatmenttreatment with standard orthodontic procedures | Procedure or surgery | Control Group II |
Primary outcome
Tooth color parameter L* change
Time frame: Up to 49 months
Lightness parameter of CIE-L*a*b* system
Tooth color parameter a* change
Time frame: Up to 49 months
Green-red component of CIE-L*a*b* system
Tooth color parameter b* change
Time frame: Up to 49 months
Blue-Yellow component of CIE-L*a*b* system
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 12 Aug 2019.
- Results publication: PubMed 21055582Karamouzos 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.
- Individual participant dataSharing planned: No
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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.
Konstantinos Lazaridis, Dr principal investigator
Aristotle University Of Thessaloniki
Questions about this trial
What is this clinical trial studying?
A study testing Combined orthodontic-orthognathic treatment and Standard orthodontic treatment in people with Discoloration, Tooth, run by Aristotle University Of Thessaloniki.
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 3 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Tooth color parameter L* change (time frame: Up to 49 months). 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?
On the ClinicalTrials.gov record for NCT03657498, which also lists 1 linked publication.
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 12 Aug 2019.