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Completed

NCT Number: NCT04452071

Gingival Crevicular Fluid Alkaline Phosphatase as Skeletal Growth Indicator

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

Completed

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Key information

Conditions

Age range

7 year–16 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Dentistry

Cairo, Manial, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

periapical xray

Radiation

periapical xray on the middle phalanax of the middle finger

Primary outcomes

  1. GCF ALP concentration

    Time frame: immediately after sample collection

    concentration of gingival crevicular fluid alkaline phosphatase

  2. MP3

    Time frame: immediately after taking x-rays

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 30, 2020
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.