Periodontal DiseasesNCT06102616
Osteocalcin Level in Gingival Clavicular Fluid During Canine Retraction in Periodontal Compromised Patients
A study testing measure Osteocalcin level in people with Periodontal Diseases, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- measure Osteocalcin level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2022to 23 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Previous orthodontic treatment.
- Patients with aggressive periodontitis or Any smoking habits.
- Pregnant or lactating female patients were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Periodontal Diseases
- Being tested
- measure Osteocalcin level
- Keywords
- osteocalsin, periodontal compromised teeth, canine retraction
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure Osteocalcin levelDiagnostic test
in gingival crevicular fluid before and during orthodontic tooth movement
| Study group | Role | What they receive |
|---|---|---|
| periodontal compromised orthodontic pateints | Experimental | periodontal compromised adults female patients with sever dental crowding and seeking for orthodontic treatment Receives: Diagnostic Test: measure Osteocalcin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteocalcin levels in gingival crevicular fluid before and during orthodontic tooth movement
ELISA test to measure osteocalcin in GCF
Measured: at baseline, then after 3 months and after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start14 Jan 2022
- Primary completion20 Mar 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohsena Ahmad, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102616
- Sponsor's protocol ID
- 12245
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteocalcin Level in Gingival Clavicular Fluid During Canine Retraction in Periodontal Compromised Patients
- ClinicalTrials.gov ID
- NCT06102616
- Acronym / sponsor ID
- 12245
- Conditions
- Periodontal Diseases
- Keywords
- osteocalsin, periodontal compromised teeth, canine retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periodontal compromised orthodontic pateints | Experimental | Diagnostic Test: measure Osteocalcin levelperiodontal compromised adults female patients with sever dental crowding and seeking for orthodontic treatment |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous orthodontic treatment.
- Patients with aggressive periodontitis or Any smoking habits.
- Pregnant or lactating female patients were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure Osteocalcin levelin gingival crevicular fluid before and during orthodontic tooth movement | Diagnostic test | periodontal compromised orthodontic pateints |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measure Osteocalcin level in people with Periodontal Diseases, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteocalcin levels in gingival crevicular fluid before and during orthodontic tooth movement (time frame: at baseline, then after 3 months and after 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.