Effect of NSRCT on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis
NCT ID: NCT05609747
Last Updated: 2022-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
62 participants
INTERVENTIONAL
2021-12-27
2022-12-30
Brief Summary
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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.
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Detailed Description
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AP may contribute to low grade systemic inflammation associated with a generalized increase in systemic inflammatory mediators such as C-reactive protein (CRP), interleukin (IL)-1, IL-2, IL-6 and Immunoglobulin (IgA, IgG and IgM) levels .
It is already established that Diabetes mellitus (DM) and periodontitis are highly prevalent non-communicable diseases worldwide and yet they are closely inter-connected with common risk factors and plausibility of increased levels of systemic inflammation. It is evident that periodontitis significantly increases the risk of cardiovascular and renal complications in patients with type 2 diabetes mellitus (T2DM) . Higher serum high-sensitivity C-reactive protein (hsCRP) levels were reported in individuals with AP when compared to healthy controls . Also, there was a positive correlation of increased serum hsCRP levels with increasing severity of AP . A meta-analysis concluded that patients with AP had higher peripheral blood levels of CRP than controls and recommended the need for further studies to evaluate whether the treatment of AP can reduce serum CRP levels . Root canal treatment can reduce systemic inflammation and early endothelial dysfunction.
There is no published prospective interventional study evaluating the effect of root canal treatment on serum hsCRP levels in diabetic patients with AP.
Therefore, the aim of this study is to assess the impact of root canal treatment on HbA1c and serum hsCRP levels in diabetic adults with AP in comparison to healthy patients with AP.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TYPE 2 DIABETIC PATIENTS
NON SURGICAL ROOT CANAL TREATMENT
Nonsurgical root canal therapy
After administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.
HEALTHY CONTROL GROUP PATIENTS
NON SURGICAL ROOT CANAL TREATMENT
Nonsurgical root canal therapy
After administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.
Interventions
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Nonsurgical root canal therapy
After administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
30 Years
65 Years
ALL
Yes
Sponsors
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Postgraduate Institute of Dental Sciences Rohtak
OTHER
Responsible Party
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Sanjay Tewari
HEAD OF THE DEPARTMENT
Locations
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PGIDS
Rohtak, Haryana, India
Post Graduate Institute of Dental Science
Rohtak, Haryana, India
Countries
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Other Identifiers
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PGIDS/BHRC/22/06/ NIKITA GARG
Identifier Type: -
Identifier Source: org_study_id
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