Effect of NSRCT on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis

NCT05609747 | Unknown DMC

• 1 other identifier: PGIDS/BHRC/22/06/ NIKITA GARG
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

To the best of knowledge, only 2 prospective studies, and 1 cross-sectional study have been reported which have seen the periapical healing after non surgical endodontic treatment in diabetic patients and their effect on HbA1c. Because of the inconsistencies in data available from the literature and considering the limitations of cross-sectional studies, further studies, especially using a prospective design, are required. So, aim is to investigate the effects of non surgical endodontic treatment on healing and systemic inflammation in individuals with and without diabetes.

Conditions

PERIAPICAL LESIONS

Outcome Measures

Primary Outcomes (2)

• Glycemic index (HbA1c) levels

  A hemoglobin A1C (HbA1C) test is a blood test that shows what your average blood sugar (glucose) level was over the past two to three months. A normal HbA1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes, and a level of 6.5% or more indicates diabetes

  Baseline to one year

• high sensitivity C- reactive protein- hsCRP.

  High-sensitivity C-reactive protein (hsCRP) (unit- mg/L)is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death among healthy individuals with no history of cardiovascular disease, and recurrent events and death in patients with acute or stable coronary syndromes. hsCRP confers additional prognostic value at all levels of cholesterol, Framingham coronary risk score, severity of the metabolic syndrome, and blood pressure, and in those with and without subclinical atherosclerosis. hsCRP levels of less than 1, 1 to 3, and greater than 3 mg/L are associated with lower, moderate, and higher cardiovascular risks, respectively.

  Baseline to one year

Secondary Outcomes (1)

• Clinical and Radiographic success

  Baseline to one year

Study Arms (2)

TYPE 2 DIABETIC PATIENTS

EXPERIMENTAL

NON SURGICAL ROOT CANAL TREATMENT

Procedure: Nonsurgical root canal therapy

HEALTHY CONTROL GROUP PATIENTS

EXPERIMENTAL

NON SURGICAL ROOT CANAL TREATMENT

Procedure: Nonsurgical root canal therapy

Interventions

Nonsurgical root canal therapy PROCEDURE

After administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.

Also known as: Root canal treatment

HEALTHY CONTROL GROUP PATIENTS; TYPE 2 DIABETIC PATIENTS

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known patient of type 2 diabetes mellitus with HbA1c ≥6.5 %. Age between 30 to 65 years. Mature permanent posterior tooth having apical periodontitis requiring primary root canal treatment.
• No evidence of systemic diseases other than diabetes being a risk factor for apical periodontitis.
• A radiographic evidence of periapical radiolucency (minimum size,≥2mm x2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests.
• No antibiotic therapy within the preceding one month.

You may not qualify if:

• Teeth with procedural errors, cracks, fractured teeth. patients with previously endodontically treated teeth with periapical radiolucencies.
• Teeth that were not suitable for rubber dam isolation. smokers, pregnant patients. Patients with moderate and severe periodontitis. Systemic diseases other than diabetes being a risk factor for apical periodontitis.
• Immunocompromised patients.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (2)

PGIDS

Rohtak, Haryana, 124001, India

Location

Post Graduate Institute of Dental Science

Rohtak, Haryana, 124001, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF THE DEPARTMENT

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 8, 2022
• Study Start: December 27, 2021
• Primary Completion: December 27, 2022
• Study Completion: December 30, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)