MedDataX Logo

Gingival Crevicular Fluid Alkaline Phosphatase as Skeletal Growth Indicator

NCT ID: NCT04452071

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-26

Study Completion Date

2020-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth Indictaor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

prepubertal

patients born in 2012-2011

periapical xray

Intervention Type RADIATION

periapical xray on the middle phalanax of the middle finger

pubertal

patients born in 2010-2009-2008-2007

periapical xray

Intervention Type RADIATION

periapical xray on the middle phalanax of the middle finger

postpubertal

patients born in 2006-2005-2004-2003

periapical xray

Intervention Type RADIATION

periapical xray on the middle phalanax of the middle finger

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

periapical xray

periapical xray on the middle phalanax of the middle finger

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sarah samir abdelrahman abelmaged

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry

Cairo, Manial, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21205168 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GCF ALP skeletal indicator

Identifier Type: -

Identifier Source: org_study_id