Clinical trial NCT05454059: 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
Overall status: COMPLETED
Phase: NA
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
PGE2
C1P
periodontitis
type 2 diabetes mellitus
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: PGE2 levels in saliva
timeFrame: baseline to 3 months after treatment
measure: C1P levels in saliva
timeFrame: baseline to 3 months after treatment
measure: HbA1c levels
timeFrame: baseline to 3 months after treatment
Secondary outcomes:
measure: Plaque index (PI)
timeFrame: baseline to 3 months after treatment
measure: Bleeding on probing index (BOP)
timeFrame: baseline to 3 months after treatment
measure: Gingival index (GI)
timeFrame: baseline to 3 months after treatment
measure: Probing pocket depth
timeFrame: baseline to 3 months after treatment
measure: Clinical attachment level (CAL)
timeFrame: baseline to 3 months after treatment
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
Study officials:
References: