Health-related Quality of LifeNCT05044481
"Impact of the Third Molars in Oral Health-related Quality of Life"
An observational study of Health-related Quality of Life and Third Molar, run by Hospital Carlos Van Buren at 1 site in Chile.
Trial summary
The aim of this study is to evaluate the impact of the third molars in oral health-related quality of life, before and after surgical removal using a validated and frequently used in international investigations instrument (OHIP-14). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health-related Quality of Life, Third Molar
- What is being tested?
- third molar surgical removal
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteChile
- Study dates
- 5 Feb 2019to 14 Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 18 years old submmited to third molars surgical removal
Who may be able to join
- Adults patients over 18 years old
Who cannot join
- Patients with chronic diseases and acute pericoronitis
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the impact of the third molars in oral health-related quality of life, before and after surgical removal using a validated and frequently used in international investigations instrument (OHIP-14).
Read the detailed description
This is a prospective study that evaluates the oral health-related quality of life through the application of the self-administered OHIP-14 before and after the surgical removal of third molars. The inclusion criteria were adults' patients older than 18 years, referred for oral surgery. Patients with chronic diseases and acute pericoronitis were excluded. The assessment was performed at three times: pre-surgical planning 1 day before surgery (T0), 10 days (T1) and 2 - 3 months after surgery (T2)
- Conditions
- Health-related Quality of Life, Third Molar
- Being tested
- third molar surgical removal
- Keywords
- Health-related quality of life, third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
third molar surgical removalProcedure or surgery
ambulatory surgical intervention of the maxilla and / or mandible for third molar removal
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)
Short form Oral Health Impact Profile (OHIP-14) was applied at 3 times: baseline, one week before surgery (T1), 10 days after surgery (T2) and 2 - 3 months after surgery (T3).
A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM).
The Short Form Oral Health Impact Profile (OHIP-14) is an instrument for assessment oral health-related quality of life.
14 ítems values: min = 0 / max = 56 higher scores mean a worse outcome
Measured: baseline to 10 days and 2 - 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start5 Feb 2019
- Primary completion3 Mar 2020
- Study completion14 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-related Quality of LifeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Carlos Van Buren
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de La Frontera
- Responsible party
- Sponsor
- Investigators
- Valentina Duarte, Principal investigator, Hospital Carlos Van Buren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044481
- Sponsor's protocol ID
- ORD 1809 / 12-08-2019
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of the Third Molars in Oral Health-related Quality of Life"
- ClinicalTrials.gov ID
- NCT05044481
- Acronym / sponsor ID
- ORD 1809 / 12-08-2019
- Conditions
- Health-related Quality of Life, Third Molar
- Keywords
- Health-related quality of life, third molar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospital Carlos Van BurenUniversity, hospital or other
- Collaborators
- Universidad de La Frontera
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 14 Jun 2020 (actual)
- First posted
- 14 Sep 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.
The aim of this study is to evaluate the impact of the third molars in oral health-related quality of life, before and after surgical removal using a validated and frequently used in international investigations instrument (OHIP-14).
Detailed description
This is a prospective study that evaluates the oral health-related quality of life through the application of the self-administered OHIP-14 before and after the surgical removal of third molars. The inclusion criteria were adults' patients older than 18 years, referred for oral surgery. Patients with chronic diseases and acute pericoronitis were excluded. The assessment was performed at three times: pre-surgical planning 1 day before surgery (T0), 10 days (T1) and 2 - 3 months after surgery (T2)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old submmited to third molars surgical removal
Key inclusion criteria (1 listed)
- Adults patients over 18 years old
Key exclusion criteria (1 listed)
- Patients with chronic diseases and acute pericoronitis
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 |
|---|---|---|
| third molar surgical removalambulatory surgical intervention of the maxilla and / or mandible for third molar removal | Procedure or surgery | – |
Primary outcome
changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)
Time frame: baseline to 10 days and 2 - 3 months after surgery
Short form Oral Health Impact Profile (OHIP-14) was applied at 3 times: baseline, one week before surgery (T1), 10 days after surgery (T2) and 2 - 3 months after surgery (T3). A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM). The Short Form Oral Health Impact Profile (OHIP-14) is an instrument for assessment oral health-related quality of life. 14 ítems values: min = 0 / max = 56 higher scores mean a worse outcome
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 Sep 2021.
- 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.
Valentina Duarte principal investigator
Hospital Carlos Van Buren
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 Health-related Quality of Life and Third Molar, run by Hospital Carlos Van Buren at 1 site in Chile.
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 1 inclusion and 1 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 Sep 2021. 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 Chile. 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?
changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14) (time frame: baseline to 10 days and 2 - 3 months after surgery). 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 Sep 2021.