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NCT Number: NCT05454059

Salivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment

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.

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Key information

Conditions

Periodontitis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases Type 2 Diabetes

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-surgical periodontal treatment

Procedure

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.

Other names: phase I periodontal therapy, scaling and root planing, full mouth debridement

ELISA test

Diagnostic Test

C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.

periodontal examination

Other

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 collection

Other

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 Level

Diagnostic Test

Measurement of HbA1c levels from blood tests

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Plaque index (PI)

    Time frame: baseline to 3 months after treatment

    The changes in PI from baseline to 3 months after non-surgical periodontal treatment

  2. Bleeding on probing index (BOP)

    Time frame: baseline to 3 months after treatment

    The changes in BOP from baseline to 3 months after non-surgical periodontal treatment

  3. Gingival index (GI)

    Time frame: baseline to 3 months after treatment

    The changes in GI from baseline to 3 months after non-surgical periodontal treatment

  4. Probing pocket depth

    Time frame: baseline to 3 months after treatment

    The changes in probing pocket depth from baseline to 3 months after non-surgical periodontal treatment

  5. Clinical attachment level (CAL)

    Time frame: baseline to 3 months after treatment

    The changes in CAL from baseline to 3 months after non-surgical periodontal treatment

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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