CariesNCT04024644
Third Molar: Caries, Periodontal Disease and Quality of Life
An observational study of Caries and Periodontal Diseases, run by University of Sao Paulo.
Trial summary
Caries and periodontal disease are chronic diseases of the oral cavity. The incidence of caries and periodontal disease can vary depending on the position of the third molar, The aim of this study was to verify possible associations between oral health-related quality of life (QoL), periodontal disease, caries lesions… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Caries, Periodontal Diseases
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 1 May 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All participants with at least one third molar erupted or partially erupted. , regardless of age, gender, cultural level or socioeconomic status could participate in the study.
Who may be able to join
- American society of anesthesiology (ASA) I patients (negative medical history)
- with at least one third molar erupted or partially erupted
Who cannot join
- systemically compromised
- allergic
- pregnants
- patients who had the four third molars included
- patients who have already undergone the extraction of one of the third molars
About this study
Official title: Third Molar: Evaluation of Caries, Periodontal Disease and Quality of Life and Its Variation Concerning to Dental Position
Caries and periodontal disease are chronic diseases of the oral cavity. The incidence of caries and periodontal disease can vary depending on the position of the third molar, The aim of this study was to verify possible associations between oral health-related quality of life (QoL), periodontal disease, caries lesions and the position of the lower third molar.
Read the detailed description
Caries and periodontal disease are chronic diseases of the oral cavity. The presence of third molar teeth can lead to periodontal disease in the region, and often can lead to injuries and damage to the oral health, having a significant impact on the quality of life. The incidence of caries and periodontal disease can vary depending on the position of the third molar. Purpose: The aim of this study was to verify possible associations between oral health-related quality of life (QoL), periodontal disease, caries lesions and the position of the lower third molar. Materials and Methods: The investigators performed a clinical, observational cross-sectional study within 116 patients that were screened attending to evaluate the need for extraction of third molars at of the specialization course of Oral and Maxillofacial Surgery of Dental School Foundation of University of São Paulo (FFO-USP). Caries, periodontal disease and quality of life are the outcomes that were evaluated by the main researcher. Caries lesions were assessed by visual tactile examination and periodontal disease through two probing sites around third molar, considering the presence of periodontal pathology when at least one periodontal probing depth was greater than 4 mm, and both were evaluated by radiograph diagnostic methods. The assessment of oral health related quality of life by Oral Health impact Profile questionary (OHIP-14), applied as an interview. The evaluation of the position of the third molars was made by clinical and panoramic radiographs according to the classification of Pell and Gregory and Winter. Data was treated and analyzed according to STATA 13.0, software with descriptive and inferential statistics. The level of significance used was 95%. The study had the approval of ethics committee from University of Sao Paulo Dental School (number 280084).
- Conditions
- Caries, Periodontal Diseases
- Keywords
- third molar, dental caries, periodontal disease, quality of life
- Medical subject headings
- Periodontal Diseases, Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries
Caries were assessed by visual tactile examination, only on occlusal surface in erupted or partially erupted third molars (visual tactile examination) and evaluation of the presence of the image on the panoramic radiograph.
Measured: throughout study completion on average of one year
Secondary outcomes (3)
periodontal disease
Periodontal disease was assessed by gingival sulcus probing in the third molars at two points: mesiobuccal and distobuccal regions. We considered the presence of Dp when the pocket was bigger than or equal to 4 mm.
Measured: throughout study completion on average of one year
Position of the lower third molars
Position of the lower third molars were assessed by panoramic radiography, according to the classification of Pell and Gregory and Winter, performed by only one evaluator, following the criteria of imaginary lines as proposed by Almendros-Marques, et al.
Measured: throughout study completion on average of one year
Oral health related quality of life: Brazilian version of OHIP-14 questionnaire
Oral health related quality of life (OHRQoL) were assessed by Brazilian version of OHIP-14 questionnaire. This instrument consists of 14 items arranged in 7 factors: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The answers were given corresponding to a total of 5 points on a Likert-type scale. The scale included the following responses: never (coded 0), hardly ever (coded 1), occasionally (coded 2), fairly often (coded 3), and very often (coded 4). The OHIP-14 scale ranged from 0 to 56, with higher scores indicating poorer QoL
Measured: throughout study completion on average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 May 2013
- Primary completion1 Oct 2013
- Study completion1 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Other
- Time perspective
- Other
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waldyr Antônio Jorge, University of Sao Paulo
- Investigators
- Waldyr A. Jorge, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024644
- Sponsor's protocol ID
- Third molar Re
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Molar: Evaluation of Caries, Periodontal Disease and Quality of Life and Its Variation Concerning to Dental Position
- ClinicalTrials.gov ID
- NCT04024644
- Acronym / sponsor ID
- Third molar Re
- Conditions
- Caries, Periodontal Diseases
- Keywords
- third molar, dental caries, periodontal disease, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Oct 2013 (actual)
- Study completion
- 1 May 2014 (actual)
- First posted
- 18 Jul 2019 (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.
Caries and periodontal disease are chronic diseases of the oral cavity. The incidence of caries and periodontal disease can vary depending on the position of the third molar, The aim of this study was to verify possible associations between oral health-related quality of life (QoL), periodontal disease, caries lesions and the position of the lower third molar.
Detailed description
Caries and periodontal disease are chronic diseases of the oral cavity. The presence of third molar teeth can lead to periodontal disease in the region, and often can lead to injuries and damage to the oral health, having a significant impact on the quality of life. The incidence of caries and periodontal disease can vary depending on the position of the third molar. Purpose: The aim of this study was to verify possible associations between oral health-related quality of life (QoL), periodontal disease, caries lesions and the position of the lower third molar. Materials and Methods: The investigators performed a clinical, observational cross-sectional study within 116 patients that were screened attending to evaluate the need for extraction of third molars at of the specialization course of Oral and Maxillofacial Surgery of Dental School Foundation of University of São Paulo (FFO-USP). Caries, periodontal disease and quality of life are the outcomes that were evaluated by the main researcher. Caries lesions were assessed by visual tactile examination and periodontal disease through two probing sites around third molar, considering the presence of periodontal pathology when at least one periodontal probing depth was greater than 4 mm, and both were evaluated by radiograph diagnostic methods. The assessment of oral health related quality of life by Oral Health impact Profile questionary (OHIP-14), applied as an interview. The evaluation of the position of the third molars was made by clinical and panoramic radiographs according to the classification of Pell and Gregory and Winter. Data was treated and analyzed according to STATA 13.0, software with descriptive and inferential statistics. The level of significance used was 95%. The study had the approval of ethics committee from University of Sao Paulo Dental School (number 280084).
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants with at least one third molar erupted or partially erupted. , regardless of age, gender, cultural level or socioeconomic status could participate in the study.
Key inclusion criteria (2 listed)
- American society of anesthesiology (ASA) I patients (negative medical history)
- with at least one third molar erupted or partially erupted
Key exclusion criteria (5 listed)
- systemically compromised
- allergic
- pregnants
- patients who had the four third molars included
- patients who have already undergone the extraction of one of the third molars
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caries
Time frame: throughout study completion on average of one year
Caries were assessed by visual tactile examination, only on occlusal surface in erupted or partially erupted third molars (visual tactile examination) and evaluation of the presence of the image on the panoramic radiograph.
3 secondary outcomes
periodontal disease
Time frame: throughout study completion on average of one year
Position of the lower third molars
Time frame: throughout study completion on average of one year
Oral health related quality of life: Brazilian version of OHIP-14 questionnaire
Time frame: throughout study completion on average of 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 18 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Waldyr A. Jorge principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Caries and Periodontal Diseases, run by University of Sao Paulo.
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 5 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 18 Jul 2019. 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?
Caries (time frame: throughout study completion on average of one year). 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 18 Jul 2019.