Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study

NCT05814965 | Unknown DMC

• 1 other identifier: Dr. Sanjay Tewari 2023
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

While cross-sectional studies have reported a significant association between diabetes and Apical Periodontics, prospective studies are scarce. This will be the first prospective interventional study to explore the cause-and-effect relation between AP and diabetes by assessment of levels of inflammatory markers in a longitudinal setting. Periapical healing in diabetics and nondiabetics will be compared after root canal treatment to evaluate the role of various physical and metabolic attributes on endodontic outcomes.

Conditions

Diabetes Mellitus, Type 2; Apical Periodontitis

Keywords

Apical Periodontitis; Diabetes mellitus; High sensitivity C-reactive protein; Tumor necrosis factor-alpha; Interleukin; Glycated hemoglobin

Outcome Measures

Primary Outcomes (5)

• PAI SCORE

  PERIAPICAL INDEX RADIOGRAPHIC EVALUATION

  12 MONTHS

• Interlukin 1B

  INFLAMMATORY MARKER BY ELISA KIT

  12 MONTHS

• IL 6

  ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT

  12 MONTHS

• TNF -ALPHA

  ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT

  12 MONTHS

• hs-CRP

  ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT

  12 MONTHS

Study Arms (4)

Diabetic patients with Apical periodontitis

EXPERIMENTAL

Diabetic patients with Apical periodontitis received Endodontics treatment in form of Root canal treatment and assessment of inflammatory and metabolic markers

Procedure: endodontic treatment in the form of root canal treatment

Healthy patients with Apical periodontitis

EXPERIMENTAL

systemically healthy participants patients with Apical periodontitis received Endodontics treatment in the form of root canal treatment and assessment of inflammatory markers

Procedure: endodontic treatment

Diabetic patients with out Apical periodontitis

ACTIVE COMPARATOR

systemic inflammatory markers along with metabolic markers will be assessed

Diagnostic Test: inflammatory markers will be assessed along with metabolic markers assessment

Healthy participants without Apical periodontitis

ACTIVE COMPARATOR

systemic inflammatory markers will be assessed

Diagnostic Test: assessment of inflammatory marker

Interventions

endodontic treatment in the form of root canal treatment PROCEDURE

Patients will receive endodontic treatment, and inflammatory markers will be assessed

Also known as: RCT

Diabetic patients with Apical periodontitis

endodontic treatment PROCEDURE

Patients will receive endodontic treatment in the form of root canal treatment, and inflammatory markers will be assessed along with metabolic markers assessment

Healthy patients with Apical periodontitis

assessment of inflammatory marker DIAGNOSTIC_TEST

assessment of inflammatory markers

Healthy participants without Apical periodontitis

inflammatory markers will be assessed along with metabolic markers assessment DIAGNOSTIC_TEST

inflammatory markers will be assessed along with metabolic markers assessment

Diabetic patients with out Apical periodontitis

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients 30-55 year age group with minimum 20 natural teeth, with pulp necrosis confirmed by cold test and electric pulp test and radiographic evidence of periapical radiolucency with PAI score of ≥3 (24) or more in at least one mature tooth.
• control in the systemically healthy group will be selected to match participants in terms of age, sex, and BMI.
• control for participants with type 2 DM will be selected to additionally match with glycaemic control, drugs and dietary measures apart from other physical attributes.

You may not qualify if:

• Patients with clinical diagnosis of moderate to severe periodontitis (≥6 sites with probing depth ≥5 mm at separate teeth, with attachment loss and radiographic alveolar bone loss), Patients with immunosuppression, pregnancy, conditions requiring prophylactic antibiotics prior to dental treatment, bleeding disorders, medical conditions that may affect study participation (e.g., unstable cardiovascular disease) and chronic inflammatory conditions like rheumatoid

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periapical Periodontitis; Diabetes Mellitus

Interventions

Endodontics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• SANJAY TEWARI

  POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SANJAY TEWARI, MDS

CONTACT

01262-283876; principalpgids@yahoo.in

SANJAY TEWARI

CONTACT

01262-283876; principalpgids@yahoo.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 280 patients 140 in DM (70 each with AP and 70 without AP) and 140 Systemically healthy (70 each with AP and 70 without AP)will be enrolled and compared for systemic markers .Subjects with AP will be provided Endodontics treatment and levels of markers will be assessed one year after Endodontics treatment. markers.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: April 5, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

IN (1)