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CompletedNCT06102616Updated Nov 28, 2023

Osteocalcin Level in Gingival Clavicular Fluid During Canine Retraction in Periodontal Compromised Patients

An interventional study of measure Osteocalcin level in Periodontal Diseases, sponsored by Faculty of Dental Medicine for Girls. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
25 Years to 35 Years
Sex
Female
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Study summary

Osteocalcin levels can be measured Gingival crevicular fluid (GCF). Changes in osteocalcin levels can provide important information about the status of bone metabolism and bone remodeling. The levels of this markers in GCF can provide information about the status of bone remodeling in the surrounding bone tissue in periodontal affected teeth.

Read the detailed description

Osteocalcin levels can be measured using a blood test or by analyzing the levels of osteocalcin in urine or saliva. Changes in osteocalcin levels can provide important information about the status of bone metabolism and bone remodeling. Osteocalcin has been found to be present in Gingival crevicular fluid (GCF), along with other bone metabolism markers such as alkaline phosphatase and tartrate-resistant acid phosphatase. The levels of these markers in GCF can provide information about the status of bone remodeling in the surrounding bone tissue. Orthodontic tooth movement is influenced by the remodelling ability of surrounding bone and soft tissue, such as PDL and gingiva. Bone remodelling occurs in coordination, requiring coupling of bone formation after resorption. Orthodontic force induces an aseptic inflammatory response, involving cytokines and chemokines. . Increased levels of osteocalcin in body fluids indicate abnormal bone turnover activity.

02

Conditions studied

  • Periodontal Diseases

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Keywords

  • osteocalsin
  • periodontal compromised teeth
  • canine retraction
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In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 15 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Faculty of Dental Medicine for Girls is the lead sponsor of 52 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Adult female patients who were seeking for orthodontic treatment with controlled previous chronic periodontitis.
  • Pocket depth of more than 5 mm before receiving non-surgical periodontal treatment or/and Pocket depth of less than 4 mm after periodontal therapy.
  • Sever to very sever irregularity of mandibular anterior arch according to Little's irregularity index ranging from 7 to 10 mm with acceptable oral hygiene.
  • all the permanent dentition excluding third molars should be present.
  • No systemic disease or history of prolonged use of medication interfering with tooth movement as corticosteroids.

Exclusion criteria

Exclusion Criteria:

  • Previous orthodontic treatment.
  • Patients with aggressive periodontitis or Any smoking habits.
  • Pregnant or lactating female patients were excluded.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    periodontal compromised orthodontic pateints

    periodontal compromised adults female patients with sever dental crowding and seeking for orthodontic treatment

    Diagnostic Test: measure Osteocalcin level

Interventions

  • Diagnostic testmeasure Osteocalcin level

    in gingival crevicular fluid before and during orthodontic tooth movement

06

What researchers measure

Primary outcomes

  1. Osteocalcin levels in gingival crevicular fluid before and during orthodontic tooth movement

    ELISA test to measure osteocalcin in GCF

    Time frame: at baseline, then after 3 months and after 6 month

07

Study locations

1 site
  • faculty of dental medicine Azhar University
    Cairo, 1871, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06102616
Lead sponsor
Faculty of Dental Medicine for Girls
Responsible party
Mohsena Ahmad (Lecturer of Orthodontics, Faculty of Dental Medicine for Girls) — Principal investigator
First posted
Oct 26, 2023
Start date
Jan 14, 2022
Primary completion
Mar 20, 2023
Completion
Aug 23, 2023
Last update
Nov 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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