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NCT03657498

In Vivo Assessment of Natural Tooth Color After Orthognathic Surgery. A Pilot Controlled Clinical Trial

Completed NA Last updated 12 August 2019
What this trial tests

NA trial testing Combined orthodontic-orthognathic treatment in Discoloration, Tooth in 26 participants. Completed in 2 February 2017.

Timeline
2 November 2010
Primary endpoint
2 February 2017
2 February 2017

Quick facts

Lead sponsorAristotle University Of Thessaloniki
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposescreening
Enrollment26
Start date2 November 2010
Primary completion2 February 2017
Estimated completion2 February 2017

Drugs / interventions tested

Conditions studied

Sponsor

Aristotle University Of Thessaloniki

Who can join

Adults 13 to 44, any sex, with Discoloration, Tooth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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