PericoronitisNCT03027622
The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patients With Mild Pericoronitis
An observational study of Pericoronitis, run by Ankara University.
Trial summary
The complications that could occur during or after the extraction of the mandibular third molar teeth with pericoronitis affect patient's life quality considerably. Various scales are used to reveal how much the life quality of patients is affected this treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pericoronitis
- What is being tested?
- quality of life in the patients with mild pericoronitis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 55 patients diagnosed with pericoronitis affecting third molars
Who may be able to join
- having the first episode of mild pericoronitis, having a good periodontal health, having an age between 18 and 25 years
- having a diagnosis of pericoronitis of a vertically erupted or semi erupted lower third molar, having no systemic discomfort and being in the ASA I and ASAII
Who cannot join
- having no lower third molar with a vertical position
- having a systemic discomfort
- having moderate to severe pericoronitis
- having a history antibiotics or NSAIID
About this study
Official title: The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patints With Mild Pericoronitis
The complications that could occur during or after the extraction of the mandibular third molar teeth with pericoronitis affect patient's life quality considerably. Various scales are used to reveal how much the life quality of patients is affected this treatment. The aim of this study is to identify the long term life quality of patients through the OHIP-14 TR scale without removing the mandibular third molar teeth with mild pericoronitis.
Read the detailed description
Increasing the lenght stay in the mouth at a maximum rate and following the patient up after the necessary treatment and information procedures are completed. As a result of clinical and radiographical examinations fifty-five voluntary patients whose average age was 24 and who have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild pericoronitis were included in the study.After the patients in the study filled out the form including their contact and demographic data and dental symptomsand completed OHIP-14 TR scale which last about 5 minutes, their curretage and operculectomy treatments were done under local anesthesia. The patients were invited for reexamination on seventh day after the treatment. Also, an active patient follow up about life quality was performed by phone at 1,3,6 month after the treatment using the self -assessment question form and the OHIP-14 TR scale.
- Conditions
- Pericoronitis
- Being tested
- quality of life in the patients with mild pericoronitis
- Keywords
- quality of life, pericoronitis, third molar
- Medical subject headings
- Pericoronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life in the patients with mild pericoronitisBehavioural
active surviallence by OHIP-14 TR after treatment
| Study group | Role | What they receive |
|---|---|---|
| long term quality of life | to evaluate conservatively managed third molars with mild pericoronitis at first, third and sixth months by using OHIP-14 TR Receives: Behavioral: quality of life in the patients with mild pericoronitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of OHIP-14 TR at the begining of experiment
numeric values of OHIP-14 TR
Measured: first month
Secondary outcomes (2)
Total score of OHIP-14 TR at third months
numeric values of OHIP-14 TR
Measured: third months
Total score of OHIP-14 TR at sixth months
numeric values of OHIP-14 TR
Measured: sixth months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PericoronitisStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cahit UCOK, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027622
- Sponsor's protocol ID
- 3/5-2015
- Status last verified
- Feb 2017
- First submitted
- 13 Jan 2017
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patints With Mild Pericoronitis
- ClinicalTrials.gov ID
- NCT03027622
- Acronym / sponsor ID
- 3/5-2015
- Conditions
- Pericoronitis
- Keywords
- quality of life, pericoronitis, third molar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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.
The complications that could occur during or after the extraction of the mandibular third molar teeth with pericoronitis affect patient's life quality considerably. Various scales are used to reveal how much the life quality of patients is affected this treatment. The aim of this study is to identify the long term life quality of patients through the OHIP-14 TR scale without removing the mandibular third molar teeth with mild pericoronitis.
Detailed description
Increasing the lenght stay in the mouth at a maximum rate and following the patient up after the necessary treatment and information procedures are completed. As a result of clinical and radiographical examinations fifty-five voluntary patients whose average age was 24 and who have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild pericoronitis were included in the study.After the patients in the study filled out the form including their contact and demographic data and dental symptomsand completed OHIP-14 TR scale which last about 5 minutes, their curretage and operculectomy treatments were done under local anesthesia. The patients were invited for reexamination on seventh day after the treatment. Also, an active patient follow up about life quality was performed by phone at 1,3,6 month after the treatment using the self -assessment question form and the OHIP-14 TR scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| long term quality of life | – | Behavioral: quality of life in the patients with mild pericoronitisto evaluate conservatively managed third molars with mild pericoronitis at first, third and sixth months by using OHIP-14 TR |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 55 patients diagnosed with pericoronitis affecting third molars
Key inclusion criteria (2 listed)
- having the first episode of mild pericoronitis, having a good periodontal health, having an age between 18 and 25 years
- having a diagnosis of pericoronitis of a vertically erupted or semi erupted lower third molar, having no systemic discomfort and being in the ASA I and ASAII
Key exclusion criteria (4 listed)
- having no lower third molar with a vertical position
- having a systemic discomfort
- having moderate to severe pericoronitis
- having a history antibiotics or NSAIID
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 |
|---|---|---|
| quality of life in the patients with mild pericoronitisactive surviallence by OHIP-14 TR after treatment | Behavioural | long term quality of life |
Primary outcome
Total score of OHIP-14 TR at the begining of experiment
Time frame: first month
numeric values of OHIP-14 TR
2 secondary outcomes
Total score of OHIP-14 TR at third months
Time frame: third months
Total score of OHIP-14 TR at sixth months
Time frame: sixth months
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 14 Feb 2017.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pericoronitis, run by Ankara University.
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 2 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 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Total score of OHIP-14 TR at the begining of experiment (time frame: first month). 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 14 Feb 2017.