PeriodontitisNCT05454059
Salivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment
A study testing Non-surgical periodontal treatment, ELISA Test and Periodontal Examination in people with Periodontitis and Type 2 Diabetes, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Diabetes and periodontal disease are the most common chronic multifactorial and inflammatory diseases in humans, and there is a bidirectional relationship between type 2 diabetes and periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Type 2 Diabetes
- What is being tested?
- Non-surgical periodontal treatment, ELISA Test and Periodontal Examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2020to 22 Jun 2022
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 30-65
- Have not received periodontal treatment in the last 6 months,
- Does not have any systemic disease and does not use drugs,
- Not using local or systemic antibiotics in the last 3 months,
- HbA1c <%7 for the controlled T2DM group,
- HbA1c ≥7% for the uncontrolled T2DM group,
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- For female patients who are not in the pregnancy or lactation period,
- Non-smoker,
- Not regularly using mouthwash/mouthwash.
Who cannot join
- Not being willing to participate in the study,
- Under 30 years old, over 65 years old
- Having any systemic disease affecting the periodontal condition,
- To use any medication that may affect the inflammatory process in the last 3 months,
- Using local or systemic antibiotics in the last 3 months,
- To have had periodontal treatment in the last 6 months,
Show all 9Show fewer
- Being in pregnancy or lactation period for female patients,
- Using mouthwash regularly
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Salivary Ceramide-1-Phosphate and Prostaglandin E2 Levels in Periodontitis Patients With Poorly and Well-Controlled Type 2 Diabetes and Effect of Non-Surgical Periodontal Treatment: A Randomized Controlled Clinical Trial
Diabetes and periodontal disease are the most common chronic multifactorial and inflammatory diseases in humans, and there is a bidirectional relationship between type 2 diabetes and periodontitis. With the negative effects of the control of these two diseases, it results in an increase in the severity of diabetes and periodontitis, and they affect many systems together. To elucidate the role of ceramide, which is one of the possible biochemical mechanisms between diabetes and the degree of glycemic control and periodontitis, in inflammation. Aim of this study is the measurement of C1P and PGE2 in saliva and the effect of non-surgical periodontal treatment, which includes the degree of control of diabetes, oral hygiene education, tooth surface cleaning and root surface arrangement, on 3 months.
A total of 102 subjects were included. Clinical periodontal measurements, saliva samples were collected from each individual at baseline and 3 months after non-surgical periodontal treatmet in periodontitis groups. Salivary C1P and PGE2 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.
- Conditions
- Periodontitis, Type 2 Diabetes
- Being tested
- Non-surgical periodontal treatment, ELISA Test, Periodontal Examination, Saliva Sample Collection, HbA1c Level
- Keywords
- saliva, prostaglandin e2, ceramide-1-phosphate, non-surgical periodontal treatment, phase I periodontal therapy, saliva biomarker, metabolic control, HbA1c, PGE2, C1P, periodontitis, type 2 diabetes mellitus
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
Also called phase I periodontal therapy, scaling and root planing, full mouth debridement
Routine non-surgical periodontal treatment will be applied to patients with periodontitis. The main aim of non-surgical periodontal treatment is to protect, heal and maintain the existing dentition. For this purpose, using manual, sonic or ultrasonic instruments, microbial dental plaque and calculus are removed by tooth surface cleaning and root surface straightening.
ELISA TestDiagnostic test
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Periodontal ExaminationOther
All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.
Saliva Sample CollectionOther
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
HbA1c LevelDiagnostic test
Measurement of HbA1c levels from blood tests
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (HH) | Active comparator | 17 systemically healthy + periodontally healthy (normoglycemic) Receives: Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection |
| Group 2 (HP) | Experimental | 17 systemic healthy + grade A periodontitis Receives: Procedure: Non-surgical periodontal treatment; Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection |
| Group 3 (T2D+H) | Active comparator | 17 T2DM (HbA1c<%7) + periodontally healthy Receives: Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Diagnostic Test: HbA1c Level |
| Group 4 (T2D+P) | Experimental | 17 T2DM (HbA1c<%7) + grade B periodontitis Receives: Procedure: Non-surgical periodontal treatment; Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Diagnostic Test: HbA1c Level |
| Group 5 (T2D-H) | Active comparator | 17 T2DM (HbA1c≥%7) + periodontally healthy Receives: Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Diagnostic Test: HbA1c Level |
| Group 6 (T2D-P) | Experimental | 17 T2DM (HbA1c≥%7) + grade C periodontitis Receives: Procedure: Non-surgical periodontal treatment; Diagnostic Test: ELISA Test; Other: Periodontal Examination; Other: Saliva Sample Collection; Diagnostic Test: HbA1c Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGE2 levels in saliva
Change in saliva PGE2 levels from baseline to 3 months after non-surgical periodontal treatment
Measured: baseline to 3 months after treatment
C1P levels in saliva
Change in saliva C1P levels from baseline to 3 months after non-surgical periodontal treatment
Measured: baseline to 3 months after treatment
HbA1c levels
Blood test in routine biochemistry laboratory for evaluation of the change in HbA1c levels of patients with type 2 diabetes from baseline to 3 months after non-surgical periodontal treatment
Measured: baseline to 3 months after treatment
Secondary outcomes (5)
Plaque index (PI)
The changes in PI from baseline to 3 months after non-surgical periodontal treatment
Measured: baseline to 3 months after treatment
Bleeding on probing index (BOP)
The changes in BOP from baseline to 3 months after non-surgical periodontal treatment
Measured: baseline to 3 months after treatment
Gingival index (GI)
The changes in GI from baseline to 3 months after non-surgical periodontal treatment
Measured: baseline to 3 months after treatment
Probing pocket depth
The changes in probing pocket depth from baseline to 3 months after non-surgical periodontal treatment
Measured: baseline to 3 months after treatment
Clinical attachment level (CAL)
The changes in CAL from baseline to 3 months after non-surgical periodontal treatment
Measured: baseline to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start22 Oct 2020
- Primary completion22 Mar 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 102 (n=102) individuals were included in the study and were divided into 6 groups. The control groups of our study were Group 1 (HH), which included 17 both systemically healthy and periodontally healthy normoglycemic individuals, Group 2 (HP), which included 17 systemic healthy with Grade A periodontitis. Periodontally healthy T2DM patients were divided into two groups according to their HbA1c levels, and 17 patients with HbA1c levels below 7% were grouped as Group 3 (T2D+H), and 17 patients with HbA1c above 7% and 7% were grouped as Group 5 (T2D-H). 17 patients with T2DM with Grade B periodontitis with an HbA1c below 7% in the last three months were included in Group 4 (T2D+P), and 17 patients T2DM and periodontitis with an HbA1C value above 7% were included in Group 6 (T2D-P).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELMAN YILMAZ CICEK, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454059
- Sponsor's protocol ID
- 2020/598
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 12 Jul 2022
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Salivary Ceramide-1-Phosphate and Prostaglandin E2 Levels in Periodontitis Patients With Poorly and Well-Controlled Type 2 Diabetes and Effect of Non-Surgical Periodontal Treatment: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05454059
- Acronym / sponsor ID
- 2020/598
- Conditions
- Periodontitis, Type 2 Diabetes
- Keywords
- saliva, prostaglandin e2, ceramide-1-phosphate, non-surgical periodontal treatment, phase I periodontal therapy, saliva biomarker, metabolic control, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 12 Jul 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.
Diabetes and periodontal disease are the most common chronic multifactorial and inflammatory diseases in humans, and there is a bidirectional relationship between type 2 diabetes and periodontitis. With the negative effects of the control of these two diseases, it results in an increase in the severity of diabetes and periodontitis, and they affect many systems together. To elucidate the role of ceramide, which is one of the possible biochemical mechanisms between diabetes and the degree of glycemic control and periodontitis, in inflammation. Aim of this study is the measurement of C1P and PGE2 in saliva and the effect of non-surgical periodontal treatment, which includes the degree of control of diabetes, oral hygiene education, tooth surface cleaning and root surface arrangement, on 3 months.
A total of 102 subjects were included. Clinical periodontal measurements, saliva samples were collected from each individual at baseline and 3 months after non-surgical periodontal treatmet in periodontitis groups. Salivary C1P and PGE2 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- A total of 102 (n=102) individuals were included in the study and were divided into 6 groups. The control groups of our study were Group 1 (HH), which included 17 both systemically healthy and periodontally healthy normoglycemic individuals, Group 2 (HP), which included 17 systemic healthy with Grade A periodontitis. Periodontally healthy T2DM patients were divided into two groups according to their HbA1c levels, and 17 patients with HbA1c levels below 7% were grouped as Group 3 (T2D+H), and 17 patients with HbA1c above 7% and 7% were grouped as Group 5 (T2D-H). 17 patients with T2DM with Grade B periodontitis with an HbA1c below 7% in the last three months were included in Group 4 (T2D+P), and 17 patients T2DM and periodontitis with an HbA1C value above 7% were included in Group 6 (T2D-P).
| Arm | Type | Receives |
|---|---|---|
| Group 1 (HH) | Active comparator | Diagnostic Test: ELISA Test, Other: Periodontal Examination, Other: Saliva Sample Collection17 systemically healthy + periodontally healthy (normoglycemic) |
| Group 2 (HP) | Experimental | Procedure: Non-surgical periodontal treatment, Diagnostic Test: ELISA Test, Other: Periodontal Examination, Other: Saliva Sample Collection17 systemic healthy + grade A periodontitis |
| Group 3 (T2D+H) | Active comparator | Diagnostic Test: ELISA Test, Other: Periodontal Examination, Other: Saliva Sample Collection, Diagnostic Test: HbA1c Level17 T2DM (HbA1c<%7) + periodontally healthy |
| Group 4 (T2D+P) | Experimental | Procedure: Non-surgical periodontal treatment, Diagnostic Test: ELISA Test, Other: Periodontal Examination, Other: Saliva Sample Collection, Diagnostic Test: HbA1c Level17 T2DM (HbA1c<%7) + grade B periodontitis |
| Group 5 (T2D-H) | Active comparator | Diagnostic Test: ELISA Test, Other: Periodontal Examination, Other: Saliva Sample Collection, Diagnostic Test: HbA1c Level17 T2DM (HbA1c≥%7) + periodontally healthy |
| Group 6 (T2D-P) | Experimental | Procedure: Non-surgical periodontal treatment, Diagnostic Test: ELISA Test, Other: Periodontal Examination, Other: Saliva Sample Collection, Diagnostic Test: HbA1c Level17 T2DM (HbA1c≥%7) + grade C periodontitis |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between the ages of 30-65
- Have not received periodontal treatment in the last 6 months,
- Does not have any systemic disease and does not use drugs,
- Not using local or systemic antibiotics in the last 3 months,
- HbA1c <%7 for the controlled T2DM group,
Key exclusion criteria (9 listed)
- Not being willing to participate in the study,
- Under 30 years old, over 65 years old
- Having any systemic disease affecting the periodontal condition,
- To use any medication that may affect the inflammatory process in the last 3 months,
- Using local or systemic antibiotics in the last 3 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 |
|---|---|---|
| Non-surgical periodontal treatmentAlso: phase I periodontal therapy, scaling and root planing, full mouth debridementRoutine non-surgical periodontal treatment will be applied to patients with periodontitis. The main aim of non-surgical periodontal treatment is to protect, heal and maintain the existing dentition. For this purpose, using manual, sonic or ultrasonic instruments, microbial dental plaque and calculus are removed by tooth surface cleaning and root surface straightening. | Procedure or surgery | Group 2 (HP), Group 4 (T2D+P), Group 6 (T2D-P) |
| ELISA TestC1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test. | Diagnostic test | Group 1 (HH), Group 2 (HP), Group 3 (T2D+H), Group 4 (T2D+P), Group 5 (T2D-H), Group 6 (T2D-P) |
| Periodontal ExaminationAll diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical/horizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis. | Other | Group 1 (HH), Group 2 (HP), Group 3 (T2D+H), Group 4 (T2D+P), Group 5 (T2D-H), Group 6 (T2D-P) |
| Saliva Sample CollectionSaliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation. | Other | Group 1 (HH), Group 2 (HP), Group 3 (T2D+H), Group 4 (T2D+P), Group 5 (T2D-H), Group 6 (T2D-P) |
| HbA1c LevelMeasurement of HbA1c levels from blood tests | Diagnostic test | Group 3 (T2D+H), Group 4 (T2D+P), Group 5 (T2D-H), Group 6 (T2D-P) |
Primary outcome
PGE2 levels in saliva
Time frame: baseline to 3 months after treatment
Change in saliva PGE2 levels from baseline to 3 months after non-surgical periodontal treatment
C1P levels in saliva
Time frame: baseline to 3 months after treatment
Change in saliva C1P levels from baseline to 3 months after non-surgical periodontal treatment
HbA1c levels
Time frame: baseline to 3 months after treatment
Blood test in routine biochemistry laboratory for evaluation of the change in HbA1c levels of patients with type 2 diabetes from baseline to 3 months after non-surgical periodontal treatment
5 secondary outcomes
Plaque index (PI)
Time frame: baseline to 3 months after treatment
Bleeding on probing index (BOP)
Time frame: baseline to 3 months after treatment
Gingival index (GI)
Time frame: baseline to 3 months after treatment
Probing pocket depth
Time frame: baseline to 3 months after treatment
Clinical attachment level (CAL)
Time frame: baseline to 3 months after treatment
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 Jul 2022.
- 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 Non-surgical periodontal treatment, ELISA Test and Periodontal Examination in people with Periodontitis and Type 2 Diabetes, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 9 inclusion and 9 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 Jul 2022. 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 Turkey (Türkiye). 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?
PGE2 levels in saliva (time frame: baseline to 3 months after treatment). The study lists 3 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 12 Jul 2022.