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

November 26, 2023 updated by: Mohsena Ahmad, Faculty of Dental Medicine for Girls
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 1871
        • Faculty of Dental Medicine Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: periodontal compromised orthodontic pateints
periodontal compromised adults female patients with sever dental crowding and seeking for orthodontic treatment
Diagnostic test: measure Osteocalcin level
in gingival crevicular fluid before and during orthodontic tooth movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteocalcin levels in gingival crevicular fluid before and during orthodontic tooth movement
Time Frame: at baseline, then after 3 months and after 6 month
ELISA test to measure osteocalcin in GCF
at baseline, then after 3 months and after 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Actual)

March 20, 2023

Study Completion (Actual)

August 23, 2023

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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