Healing of Apical periodontitis-the Effect of Diabetes Mellitus and Tobacco Smoking
NCT ID: NCT04812171
Last Updated: 2023-07-05
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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COMPLETED
200 participants
OBSERVATIONAL
2021-04-01
2023-07-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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smoker participants
Current cigarette smokers older than 18 years, without previously reported systemic disease, not taking medications influencing imunological system or bone metabolism.
Received adequate endodontic treatment of at least one tooth and attending follow-up at six months and one year following root-canal treatment.
non-surgical endodontic treatment
standard non-surgical endodontic treatment performed by endodontic specialist
non-smoker participants
Healthy non-smokers paired with smoker group according to age and gender. Received adequate endodontic treatment of at least one tooth and attending follow-up at six months and one year following root-canal treatment.
non-surgical endodontic treatment
standard non-surgical endodontic treatment performed by endodontic specialist
diabetic participants
Participants reporting diabetes melitus type II, having gycated hemoglobin test, not taking medications influencing imunological system or bone metabolism, non-smokers Received adequate endodontic treatment of at least one tooth and attending follow-up at six months and one year following root-canal treatment.
non-surgical endodontic treatment
standard non-surgical endodontic treatment performed by endodontic specialist
non-diabetic participants
Healthy non-smokers paired with diabetic group according to age and gender. Received adequate endodontic treatment of at least one tooth and attending follow-up at six months and one year following root-canal treatment.
non-surgical endodontic treatment
standard non-surgical endodontic treatment performed by endodontic specialist
Interventions
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non-surgical endodontic treatment
standard non-surgical endodontic treatment performed by endodontic specialist
Eligibility Criteria
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Inclusion Criteria
* Smoker group- everyday cigarette smoking habit, older than 18 years
* Control group-healthy non-smoker patients, older than 18 years, paired with smoker group according to age and sex
2. Influence of diabetes mellitus on apical periodontitis healing after non-surgical endodontic treatment
* Diabetic group-patients having type 2 diabetes mellitus, older than 18 years, non-smokers
* Control group-healthy patients, non-smokers, older than 18 years, paired with diabetic group according to age and sex
Exclusion Criteria
* Smoker group-systemic disease, pregnancy, taking medications that interfere with bone metabolism and immunologic response, former and occasional smokers
* Control group-former, occasional and present smokers,systemic disease, pregnancy, taking medications that interfere with bone metabolism and immunologic response
2. Influence of diabetes mellitus on apical periodontitis healing after non-surgical endodontic treatment Diabetic group-pregnancy, taking medications that interfere with bone metabolism and immunologic response, smokers Control group-patients having diabetes mellitus, pregnancy, taking medications that interfere with bone metabolism and immunologic response, smokers
18 Years
75 Years
ALL
Yes
Sponsors
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University of Rijeka
OTHER
Romana Peršić Bukmir
OTHER
Responsible Party
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Romana Peršić Bukmir
Ph.D.
Principal Investigators
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Sonja Pezelj-Ribarić, PhD,DMD
Role: STUDY_DIRECTOR
Faculty of Dental Medicine, University of Rijeka, Croatia
Locations
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University of Rijeka Faculty of Dental Medicine
Rijeka, , Croatia
Countries
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Other Identifiers
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Uniri-biomed-18-53 1183
Identifier Type: -
Identifier Source: org_study_id
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