Discoloration, Tooth 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
Verified date | August 2019 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | February 2, 2017 |
Est. primary completion date | February 2, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 44 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tooth color parameter L* change | Lightness parameter of CIE-L*a*b* system | Up to 49 months | |
Primary | Tooth color parameter a* change | Green-red component of CIE-L*a*b* system | Up to 49 months | |
Primary | Tooth color parameter b* change | Blue-Yellow component of CIE-L*a*b* system | Up to 49 months |
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