Clinical trial NCT04812171: Healing of Apical periodontitis-the Effect of Diabetes Mellitus and Tobacco Smoking
Official title: Healing of Apical Periodontitis After Nonsurgical Endodontic Treatment- the Effect of Diabetes Mellitus and Tobacco Smoking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periapical Periodontitis
Keywords: Diabetes mellitus
Periapical periodontitis
Smoking
Lead sponsor: University Hospital Rijeka
Sponsor class: OTHER
Collaborators: name: University of Rijeka
First posted: 2021-03-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of patients attending Dental Clinic of the Rijeka Clinical Hospital Centre requiring root canal treatment of at least one tooth with radiological diagnosis of apical periodontitis.

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.

Eligibility criteria: Inclusion Criteria

1. 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
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:

1. 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
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

Primary outcomes:
measure: Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment
timeFrame: one year
measure: Influence of diabetes mellitus on apical periodontitis healing after non-surgical endodontic treatment
timeFrame: one year
Secondary outcomes:
measure: Association of smoking intensity and duration with apical periodontitis healing
timeFrame: one year
measure: Association of glycated hemoglobin level (HbA1C) with apical periodontitis healing
timeFrame: one year
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: University of Rijeka Faculty of Dental Medicine
Study officials:
affiliation: Faculty of Dental Medicine, University of Rijeka, Croatia
name: Sonja Pezelj-Ribarić, PhD,DMD
role: STUDY_DIRECTOR
References: