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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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,

Show all 9Show fewer

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.

Turkey (Türkiye)1 site

Ondokuz Mayis University
Samsun

Other trials in Turkey (Türkiye)

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 groups in NCT05454059
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.

22 Oct 202022 Jun 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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.

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?

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?

On the ClinicalTrials.gov record for NCT05454059.

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; AzTrials last refreshed its copy on 8 Nov 2026.