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Clinical Trials/NCT04452071
NCT04452071CompletedNot Applicable

Gingival Crevicular Fluid Alkaline Phosphatase Activity as a Biomarker of Skeletal Maturation in Comparison to Modified Middle Phalanx of The Middle Finger (MP3) Method in a Sample of Growing Egyptian Females

Cairo University1 site in 1 country92 target enrollmentStarted: November 26, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
92
Locations
1
Primary Endpoint
MP3

Study Overview

Brief Summary

Determination of the pubertal growth spurt in Egyptian female patients using gingival crevicular fluid alkaline phosphatase

Detailed Description

assessment of the pubertal growth spurt in growing Egyptian female patients by using a simple, quick and easy method, through taking a gingival crevicular fluid alkaline phosphatase sample and measuring its concentration. Comparing the concentration of GCF ALP to the standardized middle phalanax of the middle finger MP3 we can predict if it can be an accurate and reliable method as skeletal growth indicator.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
7 Years to 16 Years (Child)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Gender: only female subjects will be included.
  • Age between 7-16 years old
  • Intermediate or late mixed dentition and permanent dentition
  • Good general health with absence of any nutritional problems or bony disease
  • No usage of any anti-inflammatories or antibiotics in the month preceding the study
  • Fully erupted upper and lower central incisors for sample collection
  • Good gingival and periodontal health as indicated by Probing depth (PD) values that should not exceed 3 mm for the whole dentition.
  • Willingness to participate in the study and sign the informed consent form

Exclusion Criteria

  • Male adolescent subjects
  • Periodontal and /or gingival disease
  • Systemic and/or bone disease
  • Growth abnormality

Outcomes

Primary Outcomes

MP3

Time Frame: immediately after taking x-rays

periapical x-ray of the middle phalanax of the middle finger

GCF ALP concentration

Time Frame: immediately after sample collection

concentration of gingival crevicular fluid alkaline phosphatase

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

sarah samir abdelrahman abelmaged

doctor

Cairo University

Study Sites (1)

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