Type I Collagen Fragments in the GCF and Saliva During OTM

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Collagen Degeneration

Intervention / Treatment
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* Other: Biological measuring of collagen fragments biomarker during orthodontic tooth movement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One arm<br>One arm nonrandomized clinical trial | Other: Biological measuring of collagen fragments biomarker during orthodontic tooth movement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic tooth movement(OTM);, Type I collagen fragments(ICTP, CTX);, Gingival crevicular fluid (GCF);, Saliva.