Periapical PeriodontitisNCT04812171
Healing of Apical periodontitis-the Effect of Diabetes Mellitus and Tobacco Smoking
An observational study of Periapical Periodontitis, run by Romana Peršić Bukmir at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- non-surgical endodontic treatment
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2021to 3 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periapical Periodontitis
- Being tested
- non-surgical endodontic treatment
- Keywords
- Diabetes mellitus, Periapical periodontitis, Smoking
- Medical subject headings
- Periapical Periodontitis, Diabetes Mellitus, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical endodontic treatmentProcedure or surgery
standard non-surgical endodontic treatment performed by endodontic specialist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: non-surgical endodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment
Comparison of apical periodontitis healing in smoker and non-smoker participants
Measured: 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
Measured: one year
Secondary outcomes (2)
Association of smoking intensity and duration with apical periodontitis healing
Calculation of association of smoking intensity and duration with apical periodontitis healing rate
Measured: one year
Association of glycated hemoglobin level (HbA1C) with apical periodontitis healing
Calculation of association of glycated hemoglobin level (HbA1C) with apical periodontitis healing rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Apr 2021
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romana Peršić Bukmir
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Sponsor-investigator, Romana Peršić Bukmir, University Hospital Rijeka
- Investigators
- Sonja Pezelj-Ribarić, PhD,DMD, Study director, Faculty of Dental Medicine, University of Rijeka, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812171
- Sponsor's protocol ID
- Uniri-biomed-18-53 1183
- Status last verified
- Jul 2023
- First submitted
- 19 Mar 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing of Apical Periodontitis After Nonsurgical Endodontic Treatment- the Effect of Diabetes Mellitus and Tobacco Smoking
- ClinicalTrials.gov ID
- NCT04812171
- Acronym / sponsor ID
- Uniri-biomed-18-53 1183
- Conditions
- Periapical Periodontitis
- Keywords
- Diabetes mellitus, Periapical periodontitis, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Romana Peršić BukmirUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| smoker participants | – | Procedure: non-surgical endodontic treatmentCurrent 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-smoker participants | – | Procedure: non-surgical endodontic treatmentHealthy 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. |
| diabetic participants | – | Procedure: non-surgical endodontic treatmentParticipants 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-diabetic participants | – | Procedure: non-surgical endodontic treatmentHealthy 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment
- Influence of diabetes mellitus on apical periodontitis healing after non-surgical endodontic treatment
Key exclusion criteria (4 listed)
- Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-surgical endodontic treatmentstandard non-surgical endodontic treatment performed by endodontic specialist | Procedure or surgery | diabetic participants, non-diabetic participants, non-smoker participants, smoker participants |
Primary outcome
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
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
2 secondary outcomes
Association of smoking intensity and duration with apical periodontitis healing
Time frame: one year
Association of glycated hemoglobin level (HbA1C) with apical periodontitis healing
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja Pezelj-Ribarić, PhD,DMD study director
Faculty of Dental Medicine, University of Rijeka, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periapical Periodontitis, run by Romana Peršić Bukmir at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.