Effect of Primary Non-surgical Endodontic Therapy on Glycaemic Control in Type 2 Diabetic Patients With Asymptomatic Apical Periodontitis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- HbA1c levels
Study Overview
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.
Detailed Description
INTRODUCTION:
Diabetes mellitus (DM) is a clinically and genetically heterogeneous group of disorders affecting the metabolism of carbohydrate, lipid or proteins, in which hyperglycemia is the main feature. These disorders are either due to insulin deficiency related to autoimmune destruction of pancreatic beta cells (type 1) or target tissue resistance to its cellular metabolic effects (type 2).1 Patients suffering from DM are known to have increased susceptibility to infections2.Evidence has consistently indicated that DM is a risk factor for increased severity of periodontal disease3,4.
Apical Periodontitis (AP) is an acute or chronic inflammation of the periodontium located at the root apex caused by bacterial infection of the pulp canal system5.
Traditionally, DM is diagnosed by either fasting or postprandial blood glucose but since 2010 American Diabetes Association (ADA) has recommended mean HbA1c as diagnostic criteria of diabetes with its threshold level of 6.5%. HbA1c is a resulting product of hemoglobin and glucose interaction and its elevated level indirectly reflects the hyperglycemic condition i.e. DM. Studies have been conducted linking periodontal disease and diabetes mellitus in terms of prevalence and worsening of glycemic control in diabetics as well as effect of periodontal treatment on glycemic control in diabetic patients. Nevarro-Sanchez et al showed significant improvement in HbA1c levels after non surgical periodontal therapy in diabetic patients .
The aim of the present trial is to evaluate the effect of endodontic therapy on glycemic status in patients with apical periodontitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
HbA1c levels
Time Frame: 3 months
Glycemic status will be evaluated using HbA1c levels.
Secondary Outcomes
No secondary outcomes reported