Oral Health Related Quality of LifeNCT06117189
Turkish Validity and Reliability of Oral Health Impact on Daily Life Questionnaire
An observational study of Oral Health Related Quality of Life, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to test Turkish validity and reliability of the Oral Health Impact on Daily Life Questionnaire (OHIDL) in adult endodontic patients.The questionnaire was translated and adapted into Turkish. Then, it was applied to two hundred twenty-two participants aged 18 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health Related Quality of Life
- What is being tested?
- Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 222 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 15 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 years and older who applied to the Department of Endodontics
Who may be able to join
- Patients aged 18 years and older who applied to the Department of Endodontics
Who cannot join
- Patients who did not speak Turkish,
- Patients having cognitive impairment,
- Patients having communication difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Validity and Reliability of Oral Health Impact on Daily Life Questionnaire in Endodontic Patients
This study aimed to test Turkish validity and reliability of the Oral Health Impact on Daily Life Questionnaire (OHIDL) in adult endodontic patients.The questionnaire was translated and adapted into Turkish. Then, it was applied to two hundred twenty-two participants aged 18 years.
Read the detailed description
This study aimed to test Turkish validity and reliability of the Oral Health Impact on Daily Life Questionnaire (OHIDL) in adult endodontic patients.
The questionnaire was translated and adapted into Turkish. Two hundred twenty-two participants aged 18 years and over without systemic disease were included. The reliability was examined by internal consistency and test-retest reliability. The construct and criterion validity were examined by evaluating the correlation of each question with the domains, the correlation of the domains with the global questions, and the correlation of Turkish-OHIDL with the Turkish version of the Oral Health Impact Scale (OHIP-14-TR). Statistical analysis was performed with SPSS 21.0 (IBM Corp, Armonk, NY, USA). P <0.05 was considered statistically significant.
- Conditions
- Oral Health Related Quality of Life
- Being tested
- Questionnaire
- Keywords
- oral health, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Oral Health Impact Daily Life questionnaire including 7 domains (eating, speaking, appearance, social, psychological, health, and finance) and 16 questions regarding perceived intensity
| Study group | Role | What they receive |
|---|---|---|
| Adult endodontic patients | Turkish version of Oral Health Impact on Daily Life questionnaire was applied to adult endodontic patients Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses Turkish validity and reliability of Oral Health Impact on Daily Life questionnaire
The reliability was examined by internal consistency and test-retest reliability. The construct and criterion validity were examined by evaluating the correlation of each question with the domains, the correlation of the domains with the global questions, and the correlation of Turkish-OHIDL with the Turkish version of the Oral Health Impact Scale (OHIP-14-TR).
Measured: One month from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 May 2023
- Primary completion30 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral 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
- Cross-sectional
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahter Sanal Cikman, Recep Tayyip Erdogan University
- Investigators
- Ahter Şanal Çıkman, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117189
- Sponsor's protocol ID
- 2023/118
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- 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 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of Oral Health Impact on Daily Life Questionnaire in Endodontic Patients
- ClinicalTrials.gov ID
- NCT06117189
- Acronym / sponsor ID
- 2023/118
- Conditions
- Oral Health Related Quality of Life
- Keywords
- oral health, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 3 Nov 2023 (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.
This study aimed to test Turkish validity and reliability of the Oral Health Impact on Daily Life Questionnaire (OHIDL) in adult endodontic patients.The questionnaire was translated and adapted into Turkish. Then, it was applied to two hundred twenty-two participants aged 18 years.
Detailed description
This study aimed to test Turkish validity and reliability of the Oral Health Impact on Daily Life Questionnaire (OHIDL) in adult endodontic patients.
The questionnaire was translated and adapted into Turkish. Two hundred twenty-two participants aged 18 years and over without systemic disease were included. The reliability was examined by internal consistency and test-retest reliability. The construct and criterion validity were examined by evaluating the correlation of each question with the domains, the correlation of the domains with the global questions, and the correlation of Turkish-OHIDL with the Turkish version of the Oral Health Impact Scale (OHIP-14-TR). Statistical analysis was performed with SPSS 21.0 (IBM Corp, Armonk, NY, USA). P <0.05 was considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult endodontic patients | – | Other: QuestionnaireTurkish version of Oral Health Impact on Daily Life questionnaire was applied to adult endodontic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older who applied to the Department of Endodontics
Key inclusion criteria (1 listed)
- Patients aged 18 years and older who applied to the Department of Endodontics
Key exclusion criteria (3 listed)
- Patients who did not speak Turkish,
- Patients having cognitive impairment,
- Patients having communication difficulties
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 |
|---|---|---|
| QuestionnaireOral Health Impact Daily Life questionnaire including 7 domains (eating, speaking, appearance, social, psychological, health, and finance) and 16 questions regarding perceived intensity | Other | Adult endodontic patients |
Primary outcome
To asses Turkish validity and reliability of Oral Health Impact on Daily Life questionnaire
Time frame: One month from the beginning of the study
The reliability was examined by internal consistency and test-retest reliability. The construct and criterion validity were examined by evaluating the correlation of each question with the domains, the correlation of the domains with the global questions, and the correlation of Turkish-OHIDL with the Turkish version of the Oral Health Impact Scale (OHIP-14-TR).
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 3 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Oral Health Related Quality of Life
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Not yet recruiting
MEBO Bio-Dressing on Patient-Reported Outcomes and Tissue Healing Following Rotary Gingival Depigmentation
Gingival Hyperpigmentation, Oral Health-Related Quality of Life
Recruiting
Evaluation of Ceramic Dental Crown Clinical Performance After Conventional Hydrofluoric Acid Etching or Gaseous Plasma Pretreatment
Prosthodontics, Dental Adhesives/Restorations Performance
Not yet recruitingObservational study
Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis.
Periodontitis, Adult, Periodontitis
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.
Ahter Şanal Çıkman principal investigator
Recep Tayyip Erdogan University
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 Oral Health Related Quality of Life, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 3 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 3 Nov 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 Turkey (Türkiye). 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?
To asses Turkish validity and reliability of Oral Health Impact on Daily Life questionnaire (time frame: One month from the beginning of the study). 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 3 Nov 2023.