NCT03657498

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2010

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

6.3 years

First QC Date

July 16, 2018

Last Update Submit

August 8, 2019

Conditions

Discoloration, Tooth

Keywords

Tooth color changesOrthognathic surgerySpectrophotometer

Outcome Measures

Primary Outcomes (3)

  • Tooth color parameter L* change

    Lightness parameter of CIE-L\*a\*b\* system

    Up to 49 months

  • Tooth color parameter a* change

    Green-red component of CIE-L\*a\*b\* system

    Up to 49 months

  • Tooth color parameter b* change

    Blue-Yellow component of CIE-L\*a\*b\* system

    Up to 49 months

Study Arms (3)

Study group

EXPERIMENTAL

Combined orthodontic-orthognathic treatment

Procedure: Combined orthodontic-orthognathic treatment

Control Group I

NO INTERVENTION

No intervention

Control Group II

ACTIVE COMPARATOR

Standard orthodontic treatment

Procedure: Standard orthodontic treatment

Interventions

Combined orthodontic-orthognathic treatmentPROCEDURE

combined treatment including orthodontics and orthognathic surgery

Study group
Standard orthodontic treatmentPROCEDURE

treatment with standard orthodontic procedures

Control Group II

Eligibility Criteria

Age13 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Previous orthodontic treatment
  • smoking
  • previous bleaching procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21055582RESULT

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Konstantinos Lazaridis, Dr

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific assosiate

Study Record Dates

First Submitted

July 16, 2018

First Posted

September 5, 2018

Study Start

November 2, 2010

Primary Completion

February 2, 2017

Study Completion

February 2, 2017

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share