Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812171
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2021-03-19
Brief Title:
Healing of Apical periodontitis-the Effect of Diabetes Mellitus and Tobacco Smoking
Sponsor:
Romana Peršić Bukmir
Organization:
University Hospital Rijeka
Study Overview
Official Title:
Healing of Apical Periodontitis After Nonsurgical Endodontic Treatment- the Effect of Diabetes Mellitus and Tobacco Smoking
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Apical periodontitis is an inflammatory process located around the apex of the root It is mainly caused by a microbial infection of the pulp space Diabetes mellitus and tobacco smoking are modulating factors that may influence the healing of apical periodontitis Present studies have disclosed an association between smoking and apical periodontitis and diabetes mellitus and apical periodontitis The aim of this study is to compare the healing of periapical bone in smokers and non-smokers and patients with diabetes mellitus type 2 and healthy participants The hypothesis of this study is that smokers and patients diagnosed with diabetes mellitus will experience slower healing with a lower success rate in comparison to control groups Apical periodontitis will be diagnosed through means of clinical examination and radiological analysis Healing of apical periodontitis will be determined using periapical radiographs utilizing periapical index This prospective study will contribute to the development of clinical guidelines concerning smokers and patients with diabetes mellitus type 2
Detailed Description:
Apical periodontitis is an inflammatory process located around the apex of the root It is mainly caused by a microbial infection of the pulp space Diabetes mellitus and tobacco smoking are modulating factors that may influence the healing of apical periodontitis Present studies have disclosed an association between smoking and apical periodontitis and diabetes mellitus and apical periodontitis The aim of this study is to compare the healing of periapical bone in smokers and non-smokers and patients with diabetes mellitus type 2 and healthy participants The hypothesis of this study is that smokers and patients diagnosed with diabetes mellitus will experience slower healing with a lower success rate in comparison to control groups Apical periodontitis will be diagnosed through means of clinical examination and radiological analysis Healing of apical periodontitis will be determined using periapical radiographs utilizing periapical index PAI One observer will be calibrated by evaluation of periapical status in 100 reference radiographs according to periapical index scoring system
In each participant only one tooth will be included in the study This will be first tooth submitted to endodontic treatment according to diagnostic priority The survey will include only teeth with adequate endodontic treatment according to following criteria post-operative periapical radiograph demonstrating adequate length and homogeneity of root canal filling no visible voids one millimeter shorter than radiologic apex and clinically and radiologically adequate permanent crown restoration Participants will attend clinical and radiological follow-up in six months and one year following root-canal treatment to assess healing rate In diabetic participants glycemic control will be determined according to the level of glycated hemoglobin which is routine procedure in these patients In smokers intensity and duration of smoking habit will be recorded This prospective study will contribute to the development of clinical guidelines concerning smokers and patients with diabetes mellitus type 2
In each participant only one tooth will be included in the study This will be first tooth submitted to endodontic treatment according to diagnostic priority The survey will include only teeth with adequate endodontic treatment according to following criteria post-operative periapical radiograph demonstrating adequate length and homogeneity of root canal filling no visible voids one millimeter shorter than radiologic apex and clinically and radiologically adequate permanent crown restoration Participants will attend clinical and radiological follow-up in six months and one year following root-canal treatment to assess healing rate In diabetic participants glycemic control will be determined according to the level of glycated hemoglobin which is routine procedure in these patients In smokers intensity and duration of smoking habit will be recorded This prospective study will contribute to the development of clinical guidelines concerning smokers and patients with diabetes mellitus type 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None