Periodontal DiseasesNCT05281796
Evaluation of Galectin-3 Levels in GCF And Saliva of Patients With Different Periodontal Diseases
An observational study of Periodontal Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- GCF obtaining and saliva obtaining
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2022to 15 Aug 2023
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Dental patients will be recruited in a consecutive manner from the clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry - Cairo University. Medical history and dental history will be taken; thorough oral examination will be done. The aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received. Nonrespondent patients or patients refusing to participate will be reported with the cause of their refusal. Conventional oral and periodontal examination will be held on a dental unit using the light of the unit, mirror and probe
Who may be able to join
- For healthy group: individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.
- For the gingivitis group: individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss.
- For the periodontitis group that has not received periodontal treatment in the last 6 months
- For the periodontitis group: individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss.
- Presence of a minimum of 15 natural teeth.
Who cannot join
- Individuals with any known systemic disease.
- Pregnant and lactating women.
- Individuals that received periodontal treatment within the last 6 months.
- Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
- Former or current smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gingival Crevicular Fluid And Salivary Levels of Galectin-3 in Patients With Gingivitis And Patients With Stage III Periodontitis: An Observational Study
The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.
Read the detailed description
The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.
This study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.
Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry-Cairo University.
- Conditions
- Periodontal Diseases
- Being tested
- GCF obtaining, saliva obtaining
- Keywords
- galectin-3
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCF obtainingDiagnostic test
GCF sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)
saliva obtainingDiagnostic test
Saliva sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)
| Study group | Role | What they receive |
|---|---|---|
| healthy patient | Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained Receives: Diagnostic Test: GCF obtaining; Diagnostic Test: saliva obtaining | |
| gingivitis patient | Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained Receives: Diagnostic Test: GCF obtaining; Diagnostic Test: saliva obtaining | |
| patients with Stage III periodontitis | Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained Receives: Diagnostic Test: GCF obtaining; Diagnostic Test: saliva obtaining |
What is being measured
The primary outcome is the main question the study is designed to answer.
galectin-3 in GCF
The total amount of Galectin-3 in GCF
Measured: 24 hours after taking the clinical measurements at the first visit
galectin-3 in saliva.
The total amount of Galectin-3 in saliva
Measured: 24 hours after taking the clinical measurements at the first visit
Secondary outcomes (4)
Pocket depth
in mm
Measured: 24 hours before taking GCF and salivary samples
Clinical attachment level
in mm
Measured: 24 hours before taking GCF and salivary samples
Bleeding on Probing
By gently probing the orifice of the gingival crevice, the periodontal probe will be inserted 1 to2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
Measured: 24 hours before taking GCF and salivary samples
Plaque Index
Scores: 0: No plaque
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen insitu only after application of a disclosing solution or by using the probe on the tooth surface.
- Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.
- Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: 24 hours before taking GCF and salivary samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start22 Jan 2022
- Primary completion15 Jun 2023
- Study completion15 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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed saad arafa ali, Cairo University
- Investigators
- Mohamed Sa Ali, master's, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281796
- Sponsor's protocol ID
- 1512022
- Status last verified
- Nov 2023
- First submitted
- 7 Mar 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid And Salivary Levels of Galectin-3 in Patients With Gingivitis And Patients With Stage III Periodontitis: An Observational Study
- ClinicalTrials.gov ID
- NCT05281796
- Acronym / sponsor ID
- 1512022
- Conditions
- Periodontal Diseases
- Keywords
- galectin-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 16 Mar 2022 (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.
The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.
Detailed description
The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.
This study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.
Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry-Cairo University.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy patient | – | Diagnostic Test: GCF obtaining, Diagnostic Test: saliva obtainingFull-mouth clinical periodontal measurements recorded, saliva and GCF obtained |
| gingivitis patient | – | Diagnostic Test: GCF obtaining, Diagnostic Test: saliva obtainingFull-mouth clinical periodontal measurements recorded, saliva and GCF obtained |
| patients with Stage III periodontitis | – | Diagnostic Test: GCF obtaining, Diagnostic Test: saliva obtainingFull-mouth clinical periodontal measurements recorded, saliva and GCF obtained |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Dental patients will be recruited in a consecutive manner from the clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry - Cairo University. Medical history and dental history will be taken; thorough oral examination will be done. The aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received. Nonrespondent patients or patients refusing to participate will be reported with the cause of their refusal. Conventional oral and periodontal examination will be held on a dental unit using the light of the unit, mirror and probe
Key inclusion criteria (5 listed)
- For healthy group: individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.
- For the gingivitis group: individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss.
- For the periodontitis group that has not received periodontal treatment in the last 6 months
- For the periodontitis group: individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss.
- Presence of a minimum of 15 natural teeth.
Key exclusion criteria (5 listed)
- Individuals with any known systemic disease.
- Pregnant and lactating women.
- Individuals that received periodontal treatment within the last 6 months.
- Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
- Former or current smokers.
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 |
|---|---|---|
| GCF obtainingGCF sample collection by Enzyme-Linked Immunosorbent Assay (ELISA) | Diagnostic test | gingivitis patient, healthy patient, patients with Stage III periodontitis |
| saliva obtainingSaliva sample collection by Enzyme-Linked Immunosorbent Assay (ELISA) | Diagnostic test | gingivitis patient, healthy patient, patients with Stage III periodontitis |
Primary outcome
galectin-3 in GCF
Time frame: 24 hours after taking the clinical measurements at the first visit
The total amount of Galectin-3 in GCF
galectin-3 in saliva.
Time frame: 24 hours after taking the clinical measurements at the first visit
The total amount of Galectin-3 in saliva
4 secondary outcomes
Pocket depth
Time frame: 24 hours before taking GCF and salivary samples
Clinical attachment level
Time frame: 24 hours before taking GCF and salivary samples
Bleeding on Probing
Time frame: 24 hours before taking GCF and salivary samples
Plaque Index
Time frame: 24 hours before taking GCF and salivary samples
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 24 Nov 2023.
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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.
Mohamed Sa Ali, master's principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by Cairo University 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 5 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 24 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?
galectin-3 in GCF (time frame: 24 hours after taking the clinical measurements at the first visit). The study lists 2 primary outcomes in all. 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 24 Nov 2023.