Generalized Periodontal Disease, AVDC Stage 3NCT05880654
IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis
A study testing Scaling & root planning in people with Generalized Periodontal Disease, AVDC Stage 3, run by Fayoum University at 2 sites in Egypt.
Trial summary
The sudy was aiming to assess and compare GCF levels of IL-39 \& IL-35 in gingival crevicular fluid and to correlate the relationship between different patient groups before and after non-surgical therapy. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Periodontal Disease, AVDC Stage 3
- What is being tested?
- Scaling & root planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2023to 15 May 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Patients treated with any type of medications and/ or antibiotics during the past 3 months,
- Pregnancy
- Lactation
- Receiving professional periodontal treatment during the past 6 months
- Current or former smokers
Trial locations and contacts
2 sites in 1 country.
About this study
The sudy was aiming to assess and compare GCF levels of IL-39 \& IL-35 in gingival crevicular fluid and to correlate the relationship between different patient groups before and after non-surgical therapy.
Read the detailed description
Methodology:
Group I (Periodontitis Group): 19 patients suffering from generalized periodontitis with T2DM age range, 35-50 years.
Group II (Periodontitis Group): 19 patients suffering from generalized periodontitis \& systemically healthy, age range: 35-50 years.
Group III (Control group): 19 Periodontally and systemically healthy volunteers who served as control subjects age range: 30-45 years.
Periodontitis participants will be collected from the outpatient clinic of oral medicine and periodontology departments in Fayoum, Beni-Swief and Ahram-Candian universities. The periodontitis included subjects will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Tonetti, MS, Greenwell, H, Kornman, KS. Staging and grading of periodontitis: framework and proposal of a new classification and case definition. J Periodontol.; 89( Suppl 1): S159- S172, 2018.)
Diabetic patients will be enrolled in this study according to the criteria of American Diabetes Association. (American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care 38: S8-S16, 2015.)
The control group will be selected from healthy subjects who attended the restorative dental clinic and has apparently clinically healthy gingiva.
Micropipettes will be used for collection of GCF samples for control group and periodontitis patients before \& after periodontal treatment.
A complete mouth non-surgical periodontal therapy will be carried out for both periodontitis groups
The levels of IL-35 in the GCF samples were assessed using an ELISA kit following the guidelines by the manufacturer.
- Being tested
- Scaling & root planning
- Keywords
- Periodontitis & Diabetes mellitus
- Medical subject headings
- Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling & root planningProcedure or surgery
Non Surgical periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Systemically healthy periodontitis | Active comparator | Non Surgical Periodontal therapy ( Scaling \& Root planning) Receives: Procedure: Scaling & root planning |
| Diabetic & Periodontitis | Active comparator | Non surgical periodontal therapy ( scaling \& root planning) Receives: Procedure: Scaling & root planning |
| Control | No intervention | Healthy group with neither Diabetes nor Periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF levels of IL-39 & IL35
Gingival crevicular fluid levels of IL-39 \& IL-35 in healthy \& diabetic patients with periodontitis
Measured: 3 months
Effect of SRP on GCF levels of IL-39 & IL35
Gingival crevicular fluid levels of IL-39 \& IL-35 in healthy \& diabetic patients with periodontitis after Scaling \& root planning
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Jan 2023
- Primary completion30 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Periodontal Disease, AVDC Stage 3Studies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Chronic periodontitis group chronic periodontitis with diabetes control group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandy Hassan, Fayoum University
- Investigators
- sandy Hassan, ass.prof, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880654
- Sponsor's protocol ID
- #REC-FDBSU/06102022-02/HS
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis
- ClinicalTrials.gov ID
- NCT05880654
- Acronym / sponsor ID
- #REC-FDBSU/06102022-02/HS
- Keywords
- Periodontitis & Diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 30 May 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.
The sudy was aiming to assess and compare GCF levels of IL-39 \& IL-35 in gingival crevicular fluid and to correlate the relationship between different patient groups before and after non-surgical therapy.
Detailed description
Methodology:
Group I (Periodontitis Group): 19 patients suffering from generalized periodontitis with T2DM age range, 35-50 years.
Group II (Periodontitis Group): 19 patients suffering from generalized periodontitis \& systemically healthy, age range: 35-50 years.
Group III (Control group): 19 Periodontally and systemically healthy volunteers who served as control subjects age range: 30-45 years.
Periodontitis participants will be collected from the outpatient clinic of oral medicine and periodontology departments in Fayoum, Beni-Swief and Ahram-Candian universities. The periodontitis included subjects will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Tonetti, MS, Greenwell, H, Kornman, KS. Staging and grading of periodontitis: framework and proposal of a new classification and case definition. J Periodontol.; 89( Suppl 1): S159- S172, 2018.)
Diabetic patients will be enrolled in this study according to the criteria of American Diabetes Association. (American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care 38: S8-S16, 2015.)
The control group will be selected from healthy subjects who attended the restorative dental clinic and has apparently clinically healthy gingiva.
Micropipettes will be used for collection of GCF samples for control group and periodontitis patients before \& after periodontal treatment.
A complete mouth non-surgical periodontal therapy will be carried out for both periodontitis groups
The levels of IL-35 in the GCF samples were assessed using an ELISA kit following the guidelines by the manufacturer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Chronic periodontitis group chronic periodontitis with diabetes control group
| Arm | Type | Receives |
|---|---|---|
| Systemically healthy periodontitis | Active comparator | Procedure: Scaling & root planningNon Surgical Periodontal therapy ( Scaling \& Root planning) |
| Diabetic & Periodontitis | Active comparator | Procedure: Scaling & root planningNon surgical periodontal therapy ( scaling \& root planning) |
| Control | No intervention | –Healthy group with neither Diabetes nor Periodontitis |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients treated with any type of medications and/ or antibiotics during the past 3 months,
- Pregnancy
- Lactation
- Receiving professional periodontal treatment during the past 6 months
- Current or former 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 |
|---|---|---|
| Scaling & root planningNon Surgical periodontal therapy | Procedure or surgery | Diabetic & Periodontitis, Systemically healthy periodontitis |
Primary outcome
GCF levels of IL-39 & IL35
Time frame: 3 months
Gingival crevicular fluid levels of IL-39 \& IL-35 in healthy \& diabetic patients with periodontitis
Effect of SRP on GCF levels of IL-39 & IL35
Time frame: 3 MONTHS
Gingival crevicular fluid levels of IL-39 \& IL-35 in healthy \& diabetic patients with periodontitis after Scaling \& root planning
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 30 May 2023.
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.
sandy Hassan, ass.prof principal investigator
associate professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling & root planning in people with Generalized Periodontal Disease, AVDC Stage 3, run by Fayoum University at 2 sites 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 0 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 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
GCF levels of IL-39 & IL35 (time frame: 3 months). 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 30 May 2023.