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

July 3, 2023 updated by: Romana Peršić Bukmir

Healing of Apical Periodontitis After Nonsurgical Endodontic Treatment- 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Rijeka, Croatia, 51000
        • University of Rijeka Faculty of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: 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.
Procedure: 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.
Procedure: 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.
Procedure: non-surgical endodontic treatment
standard non-surgical endodontic treatment performed by endodontic specialist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romana Peršić Bukmir

Collaborators

University of Rijeka

Investigators

  • Study Director: Sonja Pezelj-Ribarić, PhD,DMD, Faculty of Dental Medicine, University of Rijeka, Croatia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

July 3, 2023

Study Completion (Actual)

July 3, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uniri-biomed-18-53 1183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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