Quality of LifeOHIP-14NCT04409028
The Effect of Coronal Restoration Type on Satisfaction Patients.
A study testing Coronal restoration in people with Quality of Life, run by Melek ÇAM at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the impacts of coronal restorations of endodontic treated posterior teeth (ETPT) on the satisfaction and quality of patient's life. The patients who were chosen for this purpose were asked to fill in 3 questionnaires.Electronic charts and files of patients who received endodontic treatment… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Coronal restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2018to 10 Jan 2020
- Phase
- Interventional
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- (1) patients who received only one nonsurgical, single visit primary root canal therapy to one posterior tooth (premolar/molar) which has no periapical lesion and Class I/II coronal restoration, (2) patient's restoration had occlusal function for a minimum of 1 year, (3) patients who were ≥18 years old and no pregnancy or breastfeeding status (4) patients who had good oral hygiene and full dentition (5) patients who were on the American Society of Anesthesiology I and II.
Who cannot join
- Patients with physical disabilities and communication difficulties, periapical abscess, sinus tract, dental caries were excluded from the study. Patients who had other dental treatments such prosthetic crowns, implants, dental bleaching, filling were not included in the study. Those with open apex teeth were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Coronal Restoration Type of Endodontic Treated Posterior Teeth on Quality of Life and Satisfaction Patients.
This study aimed to evaluate the impacts of coronal restorations of endodontic treated posterior teeth (ETPT) on the satisfaction and quality of patient's life. The patients who were chosen for this purpose were asked to fill in 3 questionnaires.Electronic charts and files of patients who received endodontic treatment in our faculty between 2018 and 2020 were reviewed and chosen. The patients included in the study had been treated by the same endodontist and restorative dental specialist. The coronal restoration of the ETPT had to be either direct composite restoration (DCR) or indirect ceramic restoration (ICR). When the data of patient files and database systems were combined, 76 patients were deemed fit for this study. The patients were contacted by phone to request participation in the study. A rendezvous was created for the patients who agreed to get involved in the study, and those who came to the appointment filled in the questionnaires. Demographics, the semantic differential scale, and the OHIP-14 scores provided data that were entered into Minitab 18 software.
Read the detailed description
This cross-sectional clinical study was approved by the Ethics Committee of the Istanbul Okan University and conducted both at its Endodontics and Restorative Departments of Dentistry Faculty. A query of the Nucleus database (a patient management software) was performed to identify dental charts of patients who received endodontic treatment between December 2018 and January 2020. We searched only for primary endodontic treatment of vital tooth codes, and then selected the same endodontic specialists' patients. A total of 400 teeth were identified for screening. Next, a specified restorative dentistry specialist's patient searched within these patients, and 150 patients were obtained. The study was completed with 68 participants (n=34 each). Then data and radiographs of patients were checked out for the eligibility criteria.
- Conditions
- Quality of Life
- Being tested
- Coronal restoration
- Keywords
- OHIP-14, Quality of life, Endodontically treated teeth, Composite resin
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronal restorationProcedure or surgery
A restorative material like composite resin is condensed into the cavity of teeth.
| Study group | Role | What they receive |
|---|---|---|
| indirect restoration | Active comparator | Not described Receives: Procedure: Coronal restoration |
| direct restoration | Active comparator | Not described Receives: Procedure: Coronal restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality life of patients
the scores given by participants to OHIP-14 survey
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 posted1 Jun 2020
- Study start20 Dec 2018
- Primary completion20 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melek ÇAM
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Sponsor-investigator, Melek ÇAM, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409028
- Sponsor's protocol ID
- 12122018/100
- Acronym
- OHIP-14
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 1 Jun 2020
- 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 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coronal Restoration Type of Endodontic Treated Posterior Teeth on Quality of Life and Satisfaction Patients.
- ClinicalTrials.gov ID
- NCT04409028
- Acronym / sponsor ID
- OHIP-14 / 12122018/100
- Conditions
- Quality of Life
- Keywords
- OHIP-14, Quality of life, Endodontically treated teeth, Composite resin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Melek ÇAMUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 1 Jun 2020 (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 evaluate the impacts of coronal restorations of endodontic treated posterior teeth (ETPT) on the satisfaction and quality of patient's life. The patients who were chosen for this purpose were asked to fill in 3 questionnaires.Electronic charts and files of patients who received endodontic treatment in our faculty between 2018 and 2020 were reviewed and chosen. The patients included in the study had been treated by the same endodontist and restorative dental specialist. The coronal restoration of the ETPT had to be either direct composite restoration (DCR) or indirect ceramic restoration (ICR). When the data of patient files and database systems were combined, 76 patients were deemed fit for this study. The patients were contacted by phone to request participation in the study. A rendezvous was created for the patients who agreed to get involved in the study, and those who came to the appointment filled in the questionnaires. Demographics, the semantic differential scale, and the OHIP-14 scores provided data that were entered into Minitab 18 software.
Detailed description
This cross-sectional clinical study was approved by the Ethics Committee of the Istanbul Okan University and conducted both at its Endodontics and Restorative Departments of Dentistry Faculty. A query of the Nucleus database (a patient management software) was performed to identify dental charts of patients who received endodontic treatment between December 2018 and January 2020. We searched only for primary endodontic treatment of vital tooth codes, and then selected the same endodontic specialists' patients. A total of 400 teeth were identified for screening. Next, a specified restorative dentistry specialist's patient searched within these patients, and 150 patients were obtained. The study was completed with 68 participants (n=34 each). Then data and radiographs of patients were checked out for the eligibility criteria.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indirect restoration | Active comparator | Procedure: Coronal restoration |
| direct restoration | Active comparator | Procedure: Coronal restoration |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) patients who received only one nonsurgical, single visit primary root canal therapy to one posterior tooth (premolar/molar) which has no periapical lesion and Class I/II coronal restoration, (2) patient's restoration had occlusal function for a minimum of 1 year, (3) patients who were ≥18 years old and no pregnancy or breastfeeding status (4) patients who had good oral hygiene and full dentition (5) patients who were on the American Society of Anesthesiology I and II.
Key exclusion criteria (1 listed)
- Patients with physical disabilities and communication difficulties, periapical abscess, sinus tract, dental caries were excluded from the study. Patients who had other dental treatments such prosthetic crowns, implants, dental bleaching, filling were not included in the study. Those with open apex teeth were also excluded from the study.
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 |
|---|---|---|
| Coronal restorationA restorative material like composite resin is condensed into the cavity of teeth. | Procedure or surgery | direct restoration, indirect restoration |
Primary outcome
Quality life of patients
Time frame: one year
the scores given by participants to OHIP-14 survey
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 1 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronal restoration in people with Quality of Life, run by Melek ÇAM 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 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 1 Jun 2020. 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?
Quality life of patients (time frame: 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 1 Jun 2020.