NCT05020431

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 22, 2021

Last Update Submit

August 24, 2021

Conditions

Collagen Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

One arm

EXPERIMENTAL

One arm nonrandomized clinical trial

Other: Biological measuring of collagen fragments biomarker during orthodontic tooth movement

Interventions

Biological measuring of collagen fragments biomarker during orthodontic tooth movementOTHER

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.

One arm

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university faculty of dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Xanthomatosis, Cerebrotendinous

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesXanthomatosis

Study Officials

  • Omar Tareq

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2021

First Posted

August 25, 2021

Study Start

May 15, 2021

Primary Completion

November 15, 2021

Study Completion

January 1, 2022

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations

EG(1)