NCT04452071

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

21 days

First QC Date

June 26, 2020

Last Update Submit

June 26, 2020

Conditions

Growth Indictaor

Outcome Measures

Primary Outcomes (2)

  • GCF ALP concentration

    concentration of gingival crevicular fluid alkaline phosphatase

    immediately after sample collection

  • MP3

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

    immediately after taking x-rays

Study Arms (3)

prepubertal

patients born in 2012-2011

Radiation: periapical xray

pubertal

patients born in 2010-2009-2008-2007

Radiation: periapical xray

postpubertal

patients born in 2006-2005-2004-2003

Radiation: periapical xray

Interventions

periapical xrayRADIATION

periapical xray on the middle phalanax of the middle finger

postpubertalprepubertalpubertal

Eligibility Criteria

Age7 Years - 16 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself representation of gender identity
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Manial, Egypt

Location

Related Publications (1)

  • Perinetti G, Baccetti T, Contardo L, Di Lenarda R. Gingival crevicular fluid alkaline phosphatase activity as a non-invasive biomarker of skeletal maturation. Orthod Craniofac Res. 2011 Feb;14(1):44-50. doi: 10.1111/j.1601-6343.2010.01506.x. Epub 2010 Nov 23.

    PMID: 21205168BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

June 26, 2020

First Posted

June 30, 2020

Study Start

November 26, 2019

Primary Completion

December 17, 2019

Study Completion

January 10, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06

Locations

EG(1)