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

April 3, 2023 updated by: Postgraduate Institute of Dental Sciences Rohtak
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic patients with Apical periodontitis
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
Patients will receive endodontic treatment, and inflammatory markers will be assessed
Other Names:
  • RCT
Experimental: Healthy patients with Apical periodontitis
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
Patients will receive endodontic treatment in the form of root canal treatment, and inflammatory markers will be assessed along with metabolic markers assessment
Active Comparator: Diabetic patients with out Apical periodontitis
systemic inflammatory markers along with metabolic markers will be assessed
Diagnostic test: inflammatory markers will be assessed along with metabolic markers assessment
inflammatory markers will be assessed along with metabolic markers assessment
Active Comparator: Healthy participants without Apical periodontitis
systemic inflammatory markers will be assessed
Diagnostic test: assessment of inflammatory marker
assessment of inflammatory markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAI SCORE
Time Frame: 12 MONTHS
PERIAPICAL INDEX RADIOGRAPHIC EVALUATION
12 MONTHS
Interlukin 1B
Time Frame: 12 MONTHS
INFLAMMATORY MARKER BY ELISA KIT
12 MONTHS
IL 6
Time Frame: 12 MONTHS
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
12 MONTHS
TNF -ALPHA
Time Frame: 12 MONTHS
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
12 MONTHS
hs-CRP
Time Frame: 12 MONTHS
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
12 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Principal Investigator: SANJAY TEWARI, Post Graduate Institute Of Dental Sciences,Rohtak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 5, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr. Sanjay Tewari 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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