Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821534
• Other study ID #: 191622-128
• Status: Completed
• Phase: N/A
• First received: March 25, 2013
• Last updated: March 28, 2014
• Start date: March 2013
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will evaluate the inter-rater and intra-rater reliability of a Masseter Muscle Prominence Scale for evaluating a patient's muscle prominence and a Lower Shape Classification for evaluating a patient's lower facial shape.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror

Exclusion Criteria:

• infection of the mouth or gums, or facial skin infection requiring antibiotics

• planned dental or facial procedure

• unwillingness to be photographed and have the photos used for research, training, or educational purposes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• No Intervention
No treatment (intervention) was administered.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)	The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall's coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: =0: poor, >0 to =0.2: slight, >0.2 to =0.4: fair, >0.4 to =0.6: moderate, >0.6 to =0.8: substantial, and >0.8 to =1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.	Day 1	No
Primary	Intra-rater Reliability Using a MMPS	The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1 = minimal to 5 = very marked. Intra-rater (within raters) reliability was calculated separately for the left and right side of the face using weighted Kappa statistics. Weighted Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: =0: poor, >0 to =0.2: slight, >0.2 to =0.4: fair, >0.4 to =0.6: moderate, >0.6 to =0.8: substantial, and >0.8 to =1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.	Day 1	No
Primary	Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)	The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Inter-rater (among raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 5 facial categories. A total of 8 physicians rated each subject. The overall inter-rater agreement for Kappa statistics for all categories combined was estimated by pooling Kappa statistics for each category using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: =0: poor, >0 to =0.2: slight, >0.2 to =0.4: fair, >0.4 to =0.6: moderate, >0.6 to =0.8: substantial, and >0.8 to =1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.	Day 1	No
Primary	Intra-rater Reliability Using a LFSC	The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Intra-rater (within raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: =0: poor, >0 to =0.2: slight, >0.2 to =0.4: fair, >0.4 to =0.6: moderate, >0.6 to =0.8: substantial, and >0.8 to =1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.	Day 1	No