Gingival Crevicular Fluid Alkaline Phosphatase as Skeletal Growth Indicator

June 26, 2020 updated by: sarah samir abdelrahman abelmaged, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Manial
      • Cairo, Manial, Egypt
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Egyptian female patients with age range from 7 to 16 years old

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Male adolescent subjects
  2. Periodontal and /or gingival disease
  3. Systemic and/or bone disease

3. Growth abnormality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
prepubertal
patients born in 2012-2011
Radiation: periapical xray
periapical xray on the middle phalanax of the middle finger
pubertal
patients born in 2010-2009-2008-2007
Radiation: periapical xray
periapical xray on the middle phalanax of the middle finger
postpubertal
patients born in 2006-2005-2004-2003
Radiation: periapical xray
periapical xray on the middle phalanax of the middle finger

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GCF ALP concentration
Time Frame: immediately after sample collection
concentration of gingival crevicular fluid alkaline phosphatase
immediately after sample collection
MP3
Time Frame: immediately after taking x-rays
periapical x-ray of the middle phalanax of the middle finger
immediately after taking x-rays

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2019

Primary Completion (Actual)

December 17, 2019

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • GCF ALP skeletal indicator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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