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

Primary Purpose

PERIAPICAL LESIONS

Status
Active
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nonsurgical root canal therapy
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PERIAPICAL LESIONS

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • PGIDS
  • Post Graduate Institute of Dental Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TYPE 2 DIABETIC PATIENTS

HEALTHY CONTROL GROUP PATIENTS

Arm Description

NON SURGICAL ROOT CANAL TREATMENT

NON SURGICAL ROOT CANAL TREATMENT

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Clinical and Radiographic success
Absence of periapical alterations (radiolucency at furcal or periapical region) Scoring of each tooth will be done according to the following five point scale (PAI) Score Description Normal Periapical structure Small changes in bone structure Changes in bone structure with some mineral loss Periodontitis with well defined radiolucent area Severe periodontitis with exacerbating feature Lesions with a PAI score < 2 was considered as healed/healing.

Full Information

First Posted
October 30, 2022
Last Updated
November 14, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05609747
Brief Title
Effect of NSRCT on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis
Official Title
Effect of Non-Surgical Root Canal Treatment (NSRCT) on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2021 (Actual)
Primary Completion Date
December 27, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Both the systematic review concluded that diabetics have significantly higher prevalence of RFT with RPL. An umbrella review concluded that DM is associated with the outcome of RCT and can be considered as a pre operative prognostic factor. AP may contribute to low grade systemic inflammation associated with a generalized increase in systemic inflammatory mediators such as C-reactive protein (CRP), interleukin (IL)-1, IL-2, IL-6 and Immunoglobulin (IgA, IgG and IgM) levels . It is already established that Diabetes mellitus (DM) and periodontitis are highly prevalent non-communicable diseases worldwide and yet they are closely inter-connected with common risk factors and plausibility of increased levels of systemic inflammation. It is evident that periodontitis significantly increases the risk of cardiovascular and renal complications in patients with type 2 diabetes mellitus (T2DM) . Higher serum high-sensitivity C-reactive protein (hsCRP) levels were reported in individuals with AP when compared to healthy controls . Also, there was a positive correlation of increased serum hsCRP levels with increasing severity of AP . A meta-analysis concluded that patients with AP had higher peripheral blood levels of CRP than controls and recommended the need for further studies to evaluate whether the treatment of AP can reduce serum CRP levels . Root canal treatment can reduce systemic inflammation and early endothelial dysfunction. There is no published prospective interventional study evaluating the effect of root canal treatment on serum hsCRP levels in diabetic patients with AP. Therefore, the aim of this study is to assess the impact of root canal treatment on HbA1c and serum hsCRP levels in diabetic adults with AP in comparison to healthy patients with AP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PERIAPICAL LESIONS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TYPE 2 DIABETIC PATIENTS
Arm Type
Experimental
Arm Description
NON SURGICAL ROOT CANAL TREATMENT
Arm Title
HEALTHY CONTROL GROUP PATIENTS
Arm Type
Experimental
Arm Description
NON SURGICAL ROOT CANAL TREATMENT
Intervention Type
Procedure
Intervention Name(s)
Nonsurgical root canal therapy
Other Intervention Name(s)
Root canal treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic index (HbA1c) levels
Description
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
Time Frame
Baseline to one year
Title
high sensitivity C- reactive protein- hsCRP.
Description
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.
Time Frame
Baseline to one year
Secondary Outcome Measure Information:
Title
Clinical and Radiographic success
Description
Absence of periapical alterations (radiolucency at furcal or periapical region) Scoring of each tooth will be done according to the following five point scale (PAI) Score Description Normal Periapical structure Small changes in bone structure Changes in bone structure with some mineral loss Periodontitis with well defined radiolucent area Severe periodontitis with exacerbating feature Lesions with a PAI score < 2 was considered as healed/healing.
Time Frame
Baseline to one year

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: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
PGIDS
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Facility Name
Post Graduate Institute of Dental Science
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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

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