Back to resultsSalivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment
Primary Purpose
Periodontitis, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
ELISA Test
Periodontal Examination
Saliva Sample Collection
HbA1c Level
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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,
- For female patients who are not in the pregnancy or lactation period,
- Non-smoker,
- Not regularly using mouthwash/mouthwash.
Exclusion Criteria:
- 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,
- Being in pregnancy or lactation period for female patients,
- Using mouthwash regularly
- Smoking
Sites / Locations
- Ondokuz Mayis University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
Group 1 (HH)
Group 2 (HP)
Group 3 (T2D+H)
Group 4 (T2D+P)
Group 5 (T2D-H)
Group 6 (T2D-P)
Arm Description
17 systemically healthy + periodontally healthy (normoglycemic)
17 systemic healthy + grade A periodontitis
17 T2DM (HbA1c<%7) + periodontally healthy
17 T2DM (HbA1c<%7) + grade B periodontitis
17 T2DM (HbA1c≥%7) + periodontally healthy
17 T2DM (HbA1c≥%7) + grade C periodontitis
Outcomes
Primary Outcome Measures
PGE2 levels in saliva
Change in saliva PGE2 levels from baseline to 3 months after non-surgical periodontal treatment
C1P levels in saliva
Change in saliva C1P levels from baseline to 3 months after non-surgical periodontal 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
Secondary Outcome Measures
Plaque index (PI)
The changes in PI from baseline to 3 months after non-surgical periodontal treatment
Bleeding on probing index (BOP)
The changes in BOP from baseline to 3 months after non-surgical periodontal treatment
Gingival index (GI)
The changes in GI from baseline to 3 months after non-surgical periodontal treatment
Probing pocket depth
The changes in probing pocket depth from baseline to 3 months after non-surgical periodontal treatment
Clinical attachment level (CAL)
The changes in CAL from baseline to 3 months after non-surgical periodontal treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05454059
Brief Title
Salivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
June 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Type 2 Diabetes
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (HH)
Arm Type
Active Comparator
Arm Description
17 systemically healthy + periodontally healthy (normoglycemic)
Arm Title
Group 2 (HP)
Arm Type
Experimental
Arm Description
17 systemic healthy + grade A periodontitis
Arm Title
Group 3 (T2D+H)
Arm Type
Active Comparator
Arm Description
17 T2DM (HbA1c<%7) + periodontally healthy
Arm Title
Group 4 (T2D+P)
Arm Type
Experimental
Arm Description
17 T2DM (HbA1c<%7) + grade B periodontitis
Arm Title
Group 5 (T2D-H)
Arm Type
Active Comparator
Arm Description
17 T2DM (HbA1c≥%7) + periodontally healthy
Arm Title
Group 6 (T2D-P)
Arm Type
Experimental
Arm Description
17 T2DM (HbA1c≥%7) + grade C periodontitis
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Other Intervention Name(s)
phase I periodontal therapy, scaling and root planing, full mouth debridement
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ELISA Test
Intervention Description
C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.
Intervention Type
Other
Intervention Name(s)
Periodontal Examination
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saliva Sample Collection
Intervention Description
Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.
Intervention Type
Diagnostic Test
Intervention Name(s)
HbA1c Level
Intervention Description
Measurement of HbA1c levels from blood tests
Primary Outcome Measure Information:
Title
PGE2 levels in saliva
Description
Change in saliva PGE2 levels from baseline to 3 months after non-surgical periodontal treatment
Time Frame
baseline to 3 months after treatment
Title
C1P levels in saliva
Description
Change in saliva C1P levels from baseline to 3 months after non-surgical periodontal treatment
Time Frame
baseline to 3 months after treatment
Title
HbA1c levels
Description
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
Time Frame
baseline to 3 months after treatment
Secondary Outcome Measure Information:
Title
Plaque index (PI)
Description
The changes in PI from baseline to 3 months after non-surgical periodontal treatment
Time Frame
baseline to 3 months after treatment
Title
Bleeding on probing index (BOP)
Description
The changes in BOP from baseline to 3 months after non-surgical periodontal treatment
Time Frame
baseline to 3 months after treatment
Title
Gingival index (GI)
Description
The changes in GI from baseline to 3 months after non-surgical periodontal treatment
Time Frame
baseline to 3 months after treatment
Title
Probing pocket depth
Description
The changes in probing pocket depth from baseline to 3 months after non-surgical periodontal treatment
Time Frame
baseline to 3 months after treatment
Title
Clinical attachment level (CAL)
Description
The changes in CAL from baseline to 3 months after non-surgical periodontal treatment
Time Frame
baseline to 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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,
For female patients who are not in the pregnancy or lactation period,
Non-smoker,
Not regularly using mouthwash/mouthwash.
Exclusion Criteria:
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,
Being in pregnancy or lactation period for female patients,
Using mouthwash regularly
Smoking
Facility Information:
Facility Name
Ondokuz Mayis University
City
Samsun
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Salivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment
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