GingivitisNCT06038812
Galectin Role in Periodontal Disease
A study testing GCF sample collection and non-surgical periodontal treatment in people with Gingivitis and Periodontitis, run by Fayoum University at 1 site in Egypt.
Trial summary
This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1 and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers and/or therapeutic targets for periodontitis, in… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis
- What is being tested?
- GCF sample collection and non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 30 Sep 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smokers from both genders.
- Not suffering from systemic diseases, pregnancy/lactation.
- Not taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs before inclusion in the study by 6 months.
- Patients with only gingivitis or periodontitis stage III.
- Periodontitis patients who did not receive any professional periodontal treatment in the last 6 months.
Who cannot join
- smokers.
- having systemic diseases, pregnancy/lactation.
- taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs in the past 6 months.
- Patients having periodontitis any other stage than stage III.
- Periodontitis patients who receive any professional periodontal treatment in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Non-surgical Periodontal Treatment on Gal-1 & Gal-3 GCF Levels in Periodontitis Patients
This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1 and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers and/or therapeutic targets for periodontitis, in addition to revealing their possible role in the periodontal disease.
45 systemically healthy participants were enrolled in this investigation, equally subdivided into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups (before and after non-surgical treatment for periodontitis group) using enzyme linked immune-sorbent assay (ELISA) kit.
- Conditions
- Gingivitis, Periodontitis
- Being tested
- GCF sample collection, non-surgical periodontal treatment
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCF sample collectionDiagnostic test
collecting GCF from deepest sites by paper points
non-surgical periodontal treatmentProcedure or surgery
performing scaling and root planning using ultrasonic device and manual curettes
| Study group | Role | What they receive |
|---|---|---|
| Group I | Other | patients diagnosed with gingivitis Receives: Diagnostic Test: GCF sample collection |
| Group II | Other | patients diagnosed with periodontitis Receives: Diagnostic Test: GCF sample collection; Procedure: non-surgical periodontal treatment |
| Group III | Other | healthy control Receives: Diagnostic Test: GCF sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of gal-1 and gal-3 in GCF samples
samples are to be sent to biochemistry lab to measure galectin levels
Measured: an average of about 10 months to assess level of gal-1 & -3 after collection of GCF samples at baseline (1st appointment) for all groups and another sample collection after 4 weeks for group II after performing scaling and root planning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Aug 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayroz Tarrad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038812
- Sponsor's protocol ID
- REC-FDBSU/03082023-1/AM
- Status last verified
- Jan 2024
- First submitted
- 30 Aug 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tarrad NAF, Shaker OG, Elbanna RMH, AbdelKawy M. "Outcome of non-surgical periodontal treatment on Gal-1 and Gal-3 GCF levels in periodontitis patients: a case-control study". Clin Oral Investig. 2024 May 14;28(6):309. doi: 10.1007/s00784-024-05688-1.
PubMed 38743248
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Non-surgical Periodontal Treatment on Gal-1 & Gal-3 GCF Levels in Periodontitis Patients
- ClinicalTrials.gov ID
- NCT06038812
- Acronym / sponsor ID
- REC-FDBSU/03082023-1/AM
- Conditions
- Gingivitis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 15 Sep 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.
This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1 and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers and/or therapeutic targets for periodontitis, in addition to revealing their possible role in the periodontal disease.
45 systemically healthy participants were enrolled in this investigation, equally subdivided into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups (before and after non-surgical treatment for periodontitis group) using enzyme linked immune-sorbent assay (ELISA) kit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Other | Diagnostic Test: GCF sample collectionpatients diagnosed with gingivitis |
| Group II | Other | Diagnostic Test: GCF sample collection, Procedure: non-surgical periodontal treatmentpatients diagnosed with periodontitis |
| Group III | Other | Diagnostic Test: GCF sample collectionhealthy control |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smokers from both genders.
- Not suffering from systemic diseases, pregnancy/lactation.
- Not taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs before inclusion in the study by 6 months.
- Patients with only gingivitis or periodontitis stage III.
- Periodontitis patients who did not receive any professional periodontal treatment in the last 6 months.
Key exclusion criteria (5 listed)
- smokers.
- having systemic diseases, pregnancy/lactation.
- taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs in the past 6 months.
- Patients having periodontitis any other stage than stage III.
- Periodontitis patients who receive any professional periodontal treatment in the last 6 months.
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 sample collectioncollecting GCF from deepest sites by paper points | Diagnostic test | Group I, Group II, Group III |
| non-surgical periodontal treatmentperforming scaling and root planning using ultrasonic device and manual curettes | Procedure or surgery | Group II |
Primary outcome
assessment of gal-1 and gal-3 in GCF samples
Time frame: an average of about 10 months to assess level of gal-1 & -3 after collection of GCF samples at baseline (1st appointment) for all groups and another sample collection after 4 weeks for group II after performing scaling and root planning
samples are to be sent to biochemistry lab to measure galectin levels
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 12 Jan 2024.
- Derived from this study: PubMed 38743248Tarrad NAF, Shaker OG, Elbanna RMH, AbdelKawy M. "Outcome of non-surgical periodontal treatment on Gal-1 and Gal-3 GCF levels in periodontitis patients: a case-control study". Clin Oral Investig. 2024 May 14;28(6):309. doi: 10.1007/s00784-024-05688-1.
- 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 GCF sample collection and non-surgical periodontal treatment in people with Gingivitis and Periodontitis, run by Fayoum 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 12 Jan 2024. 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?
assessment of gal-1 and gal-3 in GCF samples (time frame: an average of about 10 months to assess level of gal-1 & -3 after collection of GCF samples at baseline (1st appointment) for all groups and another sample collection after 4 weeks for group II after performing scaling and root planning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038812, which also lists 1 linked publication.
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 12 Jan 2024.