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

Primary Purpose

Diabetes Mellitus, Type 2, Apical Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
endodontic treatment in the form of root canal treatment
endodontic treatment
assessment of inflammatory marker
inflammatory markers will be assessed along with metabolic markers assessment
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 Diabetes Mellitus, Type 2 focused on measuring Apical Periodontitis, Diabetes mellitus, High sensitivity C-reactive protein, Tumor necrosis factor-alpha, Interleukin, Glycated hemoglobin

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • PGIDSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Diabetic patients with Apical periodontitis

Healthy patients with Apical periodontitis

Diabetic patients with out Apical periodontitis

Healthy participants without Apical periodontitis

Arm Description

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

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

systemic inflammatory markers along with metabolic markers will be assessed

systemic inflammatory markers will be assessed

Outcomes

Primary Outcome Measures

PAI SCORE
PERIAPICAL INDEX RADIOGRAPHIC EVALUATION
Interlukin 1B
INFLAMMATORY MARKER BY ELISA KIT
IL 6
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
TNF -ALPHA
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
hs-CRP
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
April 3, 2023
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05814965
Brief Title
Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study
Official Title
Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
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.
Detailed Description
This prospective longitudinal interventional study will be conducted on patients with radiographic evidence of AP in at least one teeth. Total of 280 patients will be selected from the pool of the patients referred to the Outpatient Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. They will be equally divided into two broad groups either without any systemic disease (140 patients) or with type 2 DM.(140 Patients with DM). Each group further divided into 70 patients with AP and 70 control in a systemically healthy group (selected to match participants in age, sex and BMI). Similarly,70 patients with AP and 70 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. Analysis of systemic inflammatory markers IL-1b, IL-6, TNF- α and hsCRP will be done at baseline in both healthy and diabetic participants. Root canal treatment will be done in all the participants with AP and assessment of periapical healing and change in inflammatory markers will be done at 3, 6, and 12-month follow-up. Sample size: Sample size was estimated based on the difference in hsCRP level in patients with AP and healthy control. Effect size of 0.52 was calculated based on the mean difference and pooled SD of 0.91 and 1.75 respectively. Sample size of 58 per group was obtained at 80% power and 0.05 alpha level. Anticipating 20% dropout, total 70 patients per group (in 4 groups total 280 patients)will be recruited. Root Canal treatment Access opening will be done after rubber dam isolation and administration of local anesthesia. debridement of the pulp chamber will be done and all canal orifices will be identified. Negotiation of canals will be done. Working length will be determined using root ZX apex locator and will be verified radiographically. Root canal treatment will be performed with protaper rotary instrument using standard protocol. Coronal 2/3rd pre-enlargement will be performed with S1 and S2 files and apical third will be prepared with S1 followed by S2 and suitable finishing files depending on the size of apical binding file. Irrigation will be carried out using 5 mL of a 5% NaOCl solution between files. After preparation, the root canals will be irrigated with 5 mL 17% EDTA for 3 minutes to remove smear layer, followed by 5 mL 5% NaOCl. The final irrigation will be done with 5 mL distilled water. Intracanal dressing of Calcium hydroxide will be applied for 7 days and obturation of canal will be performed after 7 days on 2nd visit. The root canals will be dried using paper points and filled with laterally condensed gutta-percha (Dentsply Maillefer) and AH plus resin-after manipulation following manufacturers' instructions. Gutta- percha will be cut with a heated instrument and vertically condensed right at the orifice opening of the canals. Final composite resin restoration will be performed following manufacturer instruction. All the posterior teeth will be metal/ceramic crown after the completion of root canal treatment. Follow up Follow-up and clinical and radiographic examinations will be carried out after every three months for one year. Glycaemic control in diabetes patients will also be evaluated by HbA1c values at each follow-up interval.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Apical Periodontitis
Keywords
Apical Periodontitis, Diabetes mellitus, High sensitivity C-reactive protein, Tumor necrosis factor-alpha, Interleukin, Glycated hemoglobin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetic patients with Apical periodontitis
Arm Type
Experimental
Arm Description
Diabetic patients with Apical periodontitis received Endodontics treatment in form of Root canal treatment and assessment of inflammatory and metabolic markers
Arm Title
Healthy patients with Apical periodontitis
Arm Type
Experimental
Arm Description
systemically healthy participants patients with Apical periodontitis received Endodontics treatment in the form of root canal treatment and assessment of inflammatory markers
Arm Title
Diabetic patients with out Apical periodontitis
Arm Type
Active Comparator
Arm Description
systemic inflammatory markers along with metabolic markers will be assessed
Arm Title
Healthy participants without Apical periodontitis
Arm Type
Active Comparator
Arm Description
systemic inflammatory markers will be assessed
Intervention Type
Procedure
Intervention Name(s)
endodontic treatment in the form of root canal treatment
Other Intervention Name(s)
RCT
Intervention Description
Patients will receive endodontic treatment, and inflammatory markers will be assessed
Intervention Type
Procedure
Intervention Name(s)
endodontic treatment
Intervention Description
Patients will receive endodontic treatment in the form of root canal treatment, and inflammatory markers will be assessed along with metabolic markers assessment
Intervention Type
Diagnostic Test
Intervention Name(s)
assessment of inflammatory marker
Intervention Description
assessment of inflammatory markers
Intervention Type
Diagnostic Test
Intervention Name(s)
inflammatory markers will be assessed along with metabolic markers assessment
Intervention Description
inflammatory markers will be assessed along with metabolic markers assessment
Primary Outcome Measure Information:
Title
PAI SCORE
Description
PERIAPICAL INDEX RADIOGRAPHIC EVALUATION
Time Frame
12 MONTHS
Title
Interlukin 1B
Description
INFLAMMATORY MARKER BY ELISA KIT
Time Frame
12 MONTHS
Title
IL 6
Description
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
Time Frame
12 MONTHS
Title
TNF -ALPHA
Description
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
Time Frame
12 MONTHS
Title
hs-CRP
Description
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
Time Frame
12 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SANJAY TEWARI, MDS
Phone
01262-283876
Email
principalpgids@yahoo.in
First Name & Middle Initial & Last Name or Official Title & Degree
SANJAY TEWARI
Phone
01262-283876
Email
principalpgids@yahoo.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SANJAY TEWARI
Organizational Affiliation
POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIDS
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Sanjay Tewari, MDS
Phone
01262283876
Email
principalpgids@yahoo.in

12. IPD Sharing Statement

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

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