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NCT Number: NCT04812171

Healing of Apical periodontitis-the Effect of Diabetes Mellitus and Tobacco Smoking

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rijeka Faculty of Dental Medicine

Rijeka, 51000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment
  • 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
  • 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

  • Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment
  • 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
  • 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

Treatment and study plan

non-surgical endodontic treatment

Procedure

standard non-surgical endodontic treatment performed by endodontic specialist

Primary outcomes

  1. Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment

    Time frame: one year

    Comparison of apical periodontitis healing in smoker and non-smoker participants

  2. Influence of diabetes mellitus on apical periodontitis healing after non-surgical endodontic treatment

    Time frame: one year

    Comparison of apical periodontitis healing in diabetic and non-diabetic participants

Secondary outcomes

  1. Association of smoking intensity and duration with apical periodontitis healing

    Time frame: one year

    Calculation of association of smoking intensity and duration with apical periodontitis healing rate

  2. Association of glycated hemoglobin level (HbA1C) with apical periodontitis healing

    Time frame: one year

    Calculation of association of glycated hemoglobin level (HbA1C) with apical periodontitis healing rate

Sponsors and collaborators

Lead sponsor

Romana Peršić Bukmir

Other

Collaborators

  • University of Rijeka

Registry information

Official study title

Healing of Apical Periodontitis After Nonsurgical Endodontic Treatment- the Effect of Diabetes Mellitus and Tobacco Smoking

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2021
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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