Type I Collagen Fragments in the GCF and Saliva During OTM

Not Applicable

• Conditions: Collagen Degeneration
• Interventions: Other: Biological measuring of collagen fragments biomarker during orthodontic tooth movement

• Registration Number: NCT05020431
• Lead Sponsor: Alexandria University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-05-15
• Status Verified: 2021-08
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-27
• Primary Completion: 2021-11-15
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm	Biological measuring of collagen fragments biomarker during orthodontic tooth movement	One arm nonrandomized clinical trial

Primary Outcome Measures

Name	Time	Method
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.	21 days	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.
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.	21 days	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.

Trial Locations

Locations (1)

Alexandria university faculty of dentistry; 🇪🇬 Alexandria, Egypt