NCT06102616

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

October 22, 2023

Last Update Submit

November 26, 2023

Conditions

Keywords

osteocalsinperiodontal compromised teethcanine retraction

Outcome Measures

Primary Outcomes (1)

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

    ELISA test to measure osteocalcin in GCF

    at baseline, then after 3 months and after 6 month

Study Arms (1)

periodontal compromised orthodontic pateints

EXPERIMENTAL

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

Diagnostic Test: measure Osteocalcin level

Interventions

in gingival crevicular fluid before and during orthodontic tooth movement

periodontal compromised orthodontic pateints

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dental medicine Azhar University

Cairo, 1871, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthodontics

Study Record Dates

First Submitted

October 22, 2023

First Posted

October 26, 2023

Study Start

January 14, 2022

Primary Completion

March 20, 2023

Study Completion

August 23, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations