Type I Collagen Fragments in the GCF and Saliva During OTM

NCT ID: NCT05020431

Last Updated: 2021-08-27

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2022-01-01

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.

Conditions

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Collagen Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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One arm

One arm nonrandomized clinical trial

Group Type EXPERIMENTAL

Biological measuring of collagen fragments biomarker during orthodontic tooth movement

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Omar Tareq

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Tareq

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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Alexandria university faculty of dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Collagen Fragments ICTP, CTX.

Identifier Type: -

Identifier Source: org_study_id

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