Growth IndictaorNCT04452071
Gingival Crevicular Fluid Alkaline Phosphatase as Skeletal Growth Indicator
An observational study of Growth Indictaor, run by Cairo University at 1 site in Egypt.
Trial summary
Determination of the pubertal growth spurt in Egyptian female patients using gingival crevicular fluid alkaline phosphatase Read more about this study
- Who is it for?
- Ages 7 to 16 years, women only
- Conditions the study is for
- Growth Indictaor
- What is being tested?
- periapical xray
- Type of treatment
- Surgery or procedure
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2019to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- Women only
- Child
Study population: Egyptian female patients with age range from 7 to 16 years old
Who may be able to join
- 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
Who cannot join
- Male adolescent subjects
- Periodontal and /or gingival disease
- Systemic and/or bone disease
- 3. Growth abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Determination of the pubertal growth spurt in Egyptian female patients using gingival crevicular fluid alkaline phosphatase
Read the 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.
- Conditions
- Growth Indictaor
- Being tested
- periapical xray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periapical xrayRadiation
periapical xray on the middle phalanax of the middle finger
| Study group | Role | What they receive |
|---|---|---|
| prepubertal | patients born in 2012-2011 Receives: Radiation: periapical xray | |
| pubertal | patients born in 2010-2009-2008-2007 Receives: Radiation: periapical xray | |
| postpubertal | patients born in 2006-2005-2004-2003 Receives: Radiation: periapical xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF ALP concentration
concentration of gingival crevicular fluid alkaline phosphatase
Measured: immediately after sample collection
MP3
periapical x-ray of the middle phalanax of the middle finger
Measured: immediately after taking x-rays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start26 Nov 2019
- Primary completion17 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth IndictaorStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah samir abdelrahman abelmaged, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452071
- Sponsor's protocol ID
- GCF ALP skeletal indicator
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21205168
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04452071
- Acronym / sponsor ID
- GCF ALP skeletal indicator
- Conditions
- Growth Indictaor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prepubertal | – | Radiation: periapical xraypatients born in 2012-2011 |
| pubertal | – | Radiation: periapical xraypatients born in 2010-2009-2008-2007 |
| postpubertal | – | Radiation: periapical xraypatients born in 2006-2005-2004-2003 |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- Female only
- Age groups
- Child
- Study population
- Egyptian female patients with age range from 7 to 16 years old
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Male adolescent subjects
- Periodontal and /or gingival disease
- Systemic and/or bone disease
- 3. Growth abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periapical xrayperiapical xray on the middle phalanax of the middle finger | Radiation | postpubertal, prepubertal, pubertal |
Primary outcome
GCF ALP concentration
Time frame: immediately after sample collection
concentration of gingival crevicular fluid alkaline phosphatase
MP3
Time frame: immediately after taking x-rays
periapical x-ray of the middle phalanax of the middle finger
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Background: PubMed 21205168Perinetti 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Indictaor, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCF ALP concentration (time frame: immediately after sample collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.