NCT05609747

Effect of NSRCT on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis

Effect of Non-Surgical Root Canal Treatment (NSRCT) on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Both the systematic review concluded that diabetics have significantly higher prevalence of RFT with RPL. An umbrella review concluded that DM is associated with the outcome of RCT and can be considered as a pre operative prognostic factor. 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

• PERIAPICAL LESIONS

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2021-12-27
• Primary completion: 2022-12-27
• Completion: 2022-12-30
• First posted: 2022-11-08
• Last updated: 2022-11-16

Locations

2 sites across 1 country: India