Effect of Primary Non-surgical Endodontic Therapy on Glycaemic Control in Type 2 Diabetic Patients With Asymptomatic Apical Periodontitis

NCT05170880 | Completed

• 1 other identifier: Dr. Aparna
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of primary non-surgical endodontic therapy on glycaemic control in type 2 diabetic patients with asymptomatic apical periodontitis.After fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each patient after explaining risks, benefits and alternative treatments.The endodontic treatment for all patients will be performed by a single operator (S.A) following a standardized protocol. The control group will receive no endodontic treatment during the study period. After completion of the study, these patients will be given primary non-surgical endodontic treatment. The patients in control group will be rendered the necessary treatment, if they become symptomatic and/or deny the consent during the course of the study. These patients will be excluded from the study.

Conditions

Diabete Type 2; Apical Periodontitis

Keywords

Type 2 Diabetes Mellitus, Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• HbA1c levels

  Glycemic status will be evaluated using HbA1c levels.

  3 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

After fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each patient after explaining risks, benefits and alternative treatments.The endodontic treatment for all patients will be performed by a single operator (S.A) following a standardized protocol.

Procedure: Primary endodontic treatment

Control Group

NO INTERVENTION

The control group will receive no endodontic treatment during the study period. After completion of the study, these patients will be given primary non-surgical endodontic treatment.

Interventions

Primary endodontic treatment PROCEDURE

Primary non surgical endodontic treatment will be provided to patients in treatment group.

Treatment Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient willing to participate in the study. Patients with a history of type 2 DM (with HbA1c ≥ 6.5%), between the age of 30 to 65 years, asymptomatic mature permanent teeth with pulpal necrosis as confirmed by a negative response to cold and electric test and radiographic evidence of AP no history of systemic antibiotic administration within the last 1 month;

You may not qualify if:

• Symptomatic patients Retreatment Unwillingness of patients Procedural errors and calcified canals ,inability to achieve apical patency in any canals Immuno-compromised, pt. on long term steroids, pregnant and patient with any other systemic illness except diabetes mellitus.
• Teeth with periodontal disease.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periapical Periodontitis

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: December 28, 2021
• Study Start: February 11, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: December 28, 2021

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)