NCT04812171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

March 19, 2021

Last Update Submit

July 3, 2023

Conditions

Periapical Periodontitis

Keywords

Diabetes mellitusPeriapical periodontitisSmoking

Outcome Measures

Primary Outcomes (2)

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

    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

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

    one year

Secondary Outcomes (2)

  • Association of smoking intensity and duration with apical periodontitis healing

    one year

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

    one year

Study Arms (4)

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

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

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

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

Interventions

non-surgical endodontic treatmentPROCEDURE

standard non-surgical endodontic treatment performed by endodontic specialist

diabetic participantsnon-diabetic participantsnon-smoker participantssmoker participants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rijeka Faculty of Dental Medicine

Rijeka, 51000, Croatia

Location

MeSH Terms

Conditions

Periapical PeriodontitisDiabetes MellitusSmoking

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Sonja Pezelj-Ribarić, PhD,DMD

    Faculty of Dental Medicine, University of Rijeka, Croatia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 23, 2021

Study Start

April 1, 2021

Primary Completion

July 3, 2023

Study Completion

July 3, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

CR(1)