Type I Collagen Fragments in the GCF and Saliva During OTM

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05020431

Enrollment

Registered

2021-08-25

Start date

2021-05-15

Completion date

2022-01-01

Last updated

2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Collagen Degeneration

Keywords

Orthodontic tooth movement(OTM);, Type I collagen fragments(ICTP, CTX);, Gingival crevicular fluid (GCF);, Saliva.

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.

Interventions

OTHERBiological 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026