Type I Collagen Fragments in the GCF and Saliva During OTM

Collagen Degeneration Clinical Trial

Official title:

Detection of Type I Collagen Fragments in the Gingival Crevicular Fluid and Saliva During Orthodontic Tooth Movement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05020431
• Other study ID #: Collagen Fragments ICTP, CTX.
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigate the levels of type I Collagen fragments ICTP and CTX in GCF and saliva during initial leveling and alignment of the teeth in a sample of adolescents undergoing orthodontic treatment.

Description:

Type I Collagen fragments ICTP (cross-linked carboxyterminal telopeptide of type 1 collagen) and CTX (C-terminal cross-linked telopeptide of type I collagen) are specific bone resorption biomarkers released in the circulation after osteoclastic bone resorption and collagen degradation and were found to be released in gingival crevicular fluid (GCF) and saliva during metabolic bone diseases and active periodontitis. So the aim of the study is to investigate the levels of ICTP and CTX in GCF and saliva during initial leveling and alignment of the teeth in a sample of adolescents undergoing orthodontic treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: January 1, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• The age ranges from 13-18 years old.

• Good oral hygiene.

• Clinical gingival health on the intact periodontium.

• Permanent dentition.

• Moderate crowding.

• Non-extraction treatment plan. If extraction of teeth is required, the treatment plan should allow for postponing extraction after sample collection.

Exclusion Criteria:

• Systemic diseases associated with loss of periodontal supporting tissues.

• Metabolic bone diseases and systemic medications affecting bone metabolism.

• Craniofacial anomalies such as cleft lip and/or palate.

• Xerostomia.

• Tobacco-related habits such as smoking, tobacco chewing, etc.

Related Conditions & MeSH terms

• Collagen Degeneration

Intervention

Other:
• Biological measuring of collagen fragments biomarker during orthodontic tooth movement
Biological measure the levels of type I collagen fragments ICTP and CTX levels in the GCF and saliva during initial leveling and alignment in adolescent patients treated with fixed orthodontic appliances.

Locations

Country	Name	City	State
Egypt	Alexandria university faculty of dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of ICTP in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.	Measuring the Levels of collagen fragment ICTP in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.	21 days
Primary	Levels of CTX in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.	Measuring the Levels of collagen fragment CTX in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.	21 days