Viewing Study NCT06586775



Ignite Creation Date: 2024-10-25 @ 8:03 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06586775
Status: COMPLETED
Last Update Posted: None
First Post: 2023-12-06

Brief Title: Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth with Irreversible Pulpitis
Sponsor: None
Organization: None

Study Overview

Official Title: Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth with Irreversible Pulpitis - a Preliminary Prospective Interventional Study
Status: COMPLETED
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Endodontic research on the effects of DM on pulp tissues is scarce Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp resulting in chronic pulp inflammation and reduced dentin bridge formation To date there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis As a result of the paucity of data in the literature there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis

To the best of our knowledge no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis
Detailed Description: Introduction

Endodontic disease can affect both the pulp and the periapical areas of the tooth The resultant immune-pathological reaction could be acute or chronic inflammation depending on the ability of pulp and periapical tissue to respond to and recover from the noxious stimuli T2DM has been recognized as a crucial factor affecting the pulpal and periapical tissues in terms of susceptibility progression and healing Endodontic research on the effects of DM on pulp tissues is scarce Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp resulting in chronic pulp inflammation and reduced dentin bridge formation To date there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis As a result of the paucity of data in the literature there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis

To the best of our knowledge no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis

AIM The aim of this study is to evaluate and compare the outcome of complete pulpotomy in healthy and type 2 diabetes mellitus patients presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis

OBJECTIVES

To evaluate the clinical and radiographic success of pulpotomy with clinical and radiographic signs indicative of irreversible pulpitis
To investigate the effect of treatment outcome on glycated hemoglobin HbA1c in type 2 diabetic patients with irreversible pulpitis

RESEARCH QUESTION Does the complete pulpotomy in type 2 diabetes mellitus patients is as effective as complete pulpotomy in healthy patients in mature permanent teeth presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis PICO

P Population - Diabetic patients with mature permanent teeth with clinical and radiographic signs of irreversible pulpitis
I Intervention - Complete pulpotomy in diabetic patients
C Comparison - Complete pulpotomy in healthy patients
O Outcome - Assessment of clinical and radiographic success at 3 6 and 12 months follow-up

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None