PERIAPICAL LESIONS Clinical Trial
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
Verified date | November 2022 |
Source | Postgraduate Institute of Dental Sciences Rohtak |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 62 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 27, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | PGIDS | Rohtak | Haryana |
India | Post Graduate Institute of Dental Science | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Baseline to one year | |
Primary | 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. | Baseline to one year | |
Secondary | 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. |
Baseline to one year |
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