Dental AnxietyNCT04338854
Dental Anxiety in Children and Salivary Cortisol Levels
A study testing Restorative Treatment in people with Dental Anxiety, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aimed to assess whether pediatric dental anxiety is due to the day of dental appointment, to the dental chair, or to the dental treatment procedure during the course of the first dental treatment in children. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Restorative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2017to 25 Jul 2018
- 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 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- They were apparently healthy and had no previous experience of dental treatment
- In terms of the standardization of the groups, only the children who were compatible with Frankl-3 or 4 classes were included in the study.
- The patients were divided into groups taking into consideration the requirements of having no pain, abscess, fistula and no need for dental treatment requiring urgent intervention.
Who cannot join
- Patients, who did not meet the inclusion criteria for the study, who did not want to participate voluntarily, who ate and drank something 1 hour before the appointment, who used medication in the last 7 days, who used medication that may affect the salivary flow in the last 60 days or who left the dental treatment incomplete, were not included in the study.
- Children with Farnkl-1 and -2 classes had negative compliance to treatment and therefore they were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University
Malatya, 44280
About this study
Official title: The Evaluation of The Effect of Routine Treatments Administrated in Pedodontics Clinics on Dental Anxiety in Children and Salivary Cortisol Levels
Objective: This study aimed to assess whether pediatric dental anxiety is due to the day of dental appointment, to the dental chair, or to the dental treatment procedure during the course of the first dental treatment in children.
Study Design: Salivary cortisol samples were taken on three sequential days (pre-treatment, treatment and post-treatment days) and during the beginning and at ~15th minute of treatment, and at 15th minute post-treatment in children. They received (n=135; 15/group) root-canal treatment, pulpotomy, two- and one-surface restoration with and without local anesthesia; fluoride (with arch tray or cotton roll) or fissure sealant applications. Heart rate and SpO2 (peripheral oxygen saturation ) were monitored and The Facial Image Scale (FIS) and Children's Fear Survey Schedule-Dental subscales (CFSS-DS) were filled.
Read the detailed description
The study was carried out following the approval by the local ethics committee (Malatya Clinical Studies Ethics Committee, 2017/76), and informed consent was signed by the parents. A total of 135 children (69 females 51.1%, 66 males 49.9%), aged 7-8 years (7.37±0.48 years), were admitted to Inonu University Faculty of Dentistry Department of Pediatric Dentistry. The study was planned with 135 children with 15 children in each group. For that purpose 9 groups were formed as 6 restorative and 3 protective applications. The restorative treatment groups included procedures with- and without-local anesthesia (LA). Procedures with LA included the groups as root canal treatment, pulpotomy, two-surface restoration and one-surface restoration. Procedures without LA included the groups as two-surface restoration and one-surface restoration. The protective application groups included the groups as fluoride application (by disposable arch tray or by cotton roll) and fissure sealant. The diagnosis and treatments were carried out by the same dentist (BA).Frankl's Behaviours Rating Scale (FBRS) is a method that is frequently used in studies based on the rating of behaviours. Children's attitudes during the dental examination were evaluated using FBRS. Behaviours of the child are examined in four groups in FBRS: definitely negative (Frankl-1), negative (Frankl-2), positive (Frankl-3), and definitely positive (Frankl-4).In terms of the standardization of the groups, only the children who were compatible with Frankl-3 or 4 classes were included in the study. Children with Farnkl-1 and -2 classes had negative compliance to treatment and therefore they were not included in the study. The patients were grouped according to treatment needs. Each patient who participated in the study was informed about the treatment to be applied to him/her and the measurements to be performed by using the tell-show-apply behavior method. Furthermore, the child informed the dentist about any discomforting stimuli by "raising his/her left hand up" and the dentist stopped when he/she received this warning. In the groups treated with local anesthesia, banana or strawberry flavored topical anesthetic gel (Vision Dental Pat Gel, WP Dental, Germany) that children might like was applied first. Then, the local anesthetic solution [Ultracain D-S ampoule (40 mg articain + 0.012 mg epinephrine) Aventis Pharma, Istanbul, Turkey] was injected by the traditional method with the help of a 2 cc set inject plastic dental injector (Tıbset Sterile Medical Equipment Industry Istanbul, Turkey). Only conventional root canal treatment and extirpation were planned for the children included in the root canal treatment group in the measurement session. In the groups to be treated with pulpotomy, it was noted that at least one of the approximal surfaces of the teeth had decay and iron sulfate (ViscoStat®, UltraDent, South Jordan, USA) was used as pulpotomy material. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity. 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application.
An aerator and micromotor were used as cavity preparation in the restorative treatment groups. Only the micromotor was used for polishing purposes in the protective treatment groups. FIS (Facial Image Scale) was assessed at three stages: at the moment they sat in the dental chair, 15 minutes after the start of the treatment, and 15 minutes after the end of the treatment. From the moment the patient sat in the dental chair, the probe of the bed-side monitor was attached to the patient's left index finger, and his/her heart rate and SpO2 (peripheral oxygen saturation ) of were monitored during the treatment period and the data were recorded. After the treatment of the patients was completed in that appointment, the CFSS-DS (Children's Fear Survey Schedule-Dental Subscales) was filled in by the patients under the supervision of their parents. In the mornings, 3 salivary samples were taken from the patients by their parents in the home environment, i.e. one day before the treatment, on the day of treatment and one day after the treatment. The non-stimulated total saliva was collected from the patients. The parents were warned about the fact that all of the three salivary samples should be taken at the 30th minute after awakening, between 07:00 and 07:30 am. Eating, drinking, brushing the teeth and using dental care products were not allowed. During the treatment period in the clinic, salivary samples were taken between 09.00 and 11.00 am. Saliva samples were taken in 3 stages, i.e. at the beginning of the treatment, at the 15th minute of the treatment, and 15 minutes after the end of the treatment. Sampling at 15th minute of the treatment process was standardized to correspond to the cavity with an aerator (at the enamel level) in restorative treatment groups and to the stage of polishing procedure with a micro motor in protective treatment groups. These measures were taken to prevent the saliva from contaminating the cavity.
- Conditions
- Dental Anxiety
- Being tested
- Restorative Treatment
- Keywords
- dental anxiety, cortisol, procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorative TreatmentProcedure or surgery
Also called Protective Application
9 groups were formed as 6 restorative and 3 protective applications. The restorative treatment groups included procedures with- and without-local anesthesia (LA). Procedures with LA included the groups as root canal treatment, pulpotomy, two-surface restoration and one-surface restoration. Procedures without LA included the groups as two-surface restoration and one-surface restoration. The protective application groups included the groups as fluoride application (by disposable arch tray or by cotton roll) and fissure sealant.
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment | Experimental | It's one of the restorative groups with LA (Local Anesthesia). An aerator and micromotor were used as cavity preparation in this group. Only conventional root canal treatment and extirpation were planned for the children included in the root canal treatment group in the measurement session. Receives: Procedure: Restorative Treatment |
| Pulpotomy treatment | Experimental | It's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group. it was noted that at least one of the approximal surfaces of the teeth had decay and iron sulfate (ViscoStat®, UltraDent, South Jordan, USA) was used as pulpotomy material Receives: Procedure: Restorative Treatment |
| two-surface restoration with Local Anesthesia | Experimental | It's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity. Receives: Procedure: Restorative Treatment |
| one surface restoration with Local Anesthesia | Experimental | It's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group. Receives: Procedure: Restorative Treatment |
| two-surface restoration without Local Anesthesia | Experimental | An aerator and micromotor were used as cavity preparation in this group. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity. Receives: Procedure: Restorative Treatment |
| one surface restoration without Local Anesthesia | Experimental | An aerator and micromotor were used as cavity preparation in this group. Receives: Procedure: Restorative Treatment |
| fluoride application by disposable arch tray | Experimental | It's one of the protective groups.Only the micromotor was used for polishing purposes in the protective treatment groups. 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application. Receives: Procedure: Restorative Treatment |
| fluoride application by cotton roll | Experimental | It's one of the protective groups. Only the micromotor was used for polishing purposes in the protective treatment groups 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application. Receives: Procedure: Restorative Treatment |
| Fissure Sealant group | Experimental | It's one of the protective groups. Only the micromotor was used for polishing purposes in the protective treatment groups. Receives: Procedure: Restorative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol levels at home
the day before treatment
Measured: 30th minute after awakening, between 07:00 and 07:30 am.
Salivary cortisol levels at home
the treatment day
Measured: 30th minute after awakening, between 07:00 and 07:30 am.
Salivary cortisol levels at home
the day after treatment
Measured: 30th minute after awakening, between 07:00 and 07:30 am.
Salivary cortisol levels at clinic
the treatment day
Measured: beginning of the treatment, between 09:00 and 11:00 am.
Salivary cortisol levels in clinic
the treatment day
Measured: 15th minute of the treatment, between 09:00 and 11:00 am.
Salivary cortisol levels in clinic
the treatment day
Measured: 15th minute post treatment, between 09:00 and 11:00 am.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start15 Dec 2017
- Primary completion20 Apr 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Acar, Inonu University
- Investigators
- Burçin Acar, Dr, Principal investigator, Inonu UniversityGulsum Duruk, Dr, Study director, Inonu UniversitySedat Yildiz, Prof., Study chair, Inonu UniversityCihat Uçar, Dr, Study chair, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338854
- Sponsor's protocol ID
- 2017-840
- Status last verified
- Apr 2020
- First submitted
- 10 Feb 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yfanti K, Kitraki E, Emmanouil D, Pandis N, Papagiannoulis L. Psychometric and biohormonal indices of dental anxiety in children. A prospective cohort study. Stress. 2014 Jul;17(4):296-304. doi: 10.3109/10253890.2014.918602. Epub 2014 May 27.
PubMed 24766350
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of The Effect of Routine Treatments Administrated in Pedodontics Clinics on Dental Anxiety in Children and Salivary Cortisol Levels
- ClinicalTrials.gov ID
- NCT04338854
- Acronym / sponsor ID
- 2017-840
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, cortisol, procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 8 Apr 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.
Objective: This study aimed to assess whether pediatric dental anxiety is due to the day of dental appointment, to the dental chair, or to the dental treatment procedure during the course of the first dental treatment in children.
Study Design: Salivary cortisol samples were taken on three sequential days (pre-treatment, treatment and post-treatment days) and during the beginning and at ~15th minute of treatment, and at 15th minute post-treatment in children. They received (n=135; 15/group) root-canal treatment, pulpotomy, two- and one-surface restoration with and without local anesthesia; fluoride (with arch tray or cotton roll) or fissure sealant applications. Heart rate and SpO2 (peripheral oxygen saturation ) were monitored and The Facial Image Scale (FIS) and Children's Fear Survey Schedule-Dental subscales (CFSS-DS) were filled.
Detailed description
The study was carried out following the approval by the local ethics committee (Malatya Clinical Studies Ethics Committee, 2017/76), and informed consent was signed by the parents. A total of 135 children (69 females 51.1%, 66 males 49.9%), aged 7-8 years (7.37±0.48 years), were admitted to Inonu University Faculty of Dentistry Department of Pediatric Dentistry. The study was planned with 135 children with 15 children in each group. For that purpose 9 groups were formed as 6 restorative and 3 protective applications. The restorative treatment groups included procedures with- and without-local anesthesia (LA). Procedures with LA included the groups as root canal treatment, pulpotomy, two-surface restoration and one-surface restoration. Procedures without LA included the groups as two-surface restoration and one-surface restoration. The protective application groups included the groups as fluoride application (by disposable arch tray or by cotton roll) and fissure sealant. The diagnosis and treatments were carried out by the same dentist (BA).Frankl's Behaviours Rating Scale (FBRS) is a method that is frequently used in studies based on the rating of behaviours. Children's attitudes during the dental examination were evaluated using FBRS. Behaviours of the child are examined in four groups in FBRS: definitely negative (Frankl-1), negative (Frankl-2), positive (Frankl-3), and definitely positive (Frankl-4).In terms of the standardization of the groups, only the children who were compatible with Frankl-3 or 4 classes were included in the study. Children with Farnkl-1 and -2 classes had negative compliance to treatment and therefore they were not included in the study. The patients were grouped according to treatment needs. Each patient who participated in the study was informed about the treatment to be applied to him/her and the measurements to be performed by using the tell-show-apply behavior method. Furthermore, the child informed the dentist about any discomforting stimuli by "raising his/her left hand up" and the dentist stopped when he/she received this warning. In the groups treated with local anesthesia, banana or strawberry flavored topical anesthetic gel (Vision Dental Pat Gel, WP Dental, Germany) that children might like was applied first. Then, the local anesthetic solution [Ultracain D-S ampoule (40 mg articain + 0.012 mg epinephrine) Aventis Pharma, Istanbul, Turkey] was injected by the traditional method with the help of a 2 cc set inject plastic dental injector (Tıbset Sterile Medical Equipment Industry Istanbul, Turkey). Only conventional root canal treatment and extirpation were planned for the children included in the root canal treatment group in the measurement session. In the groups to be treated with pulpotomy, it was noted that at least one of the approximal surfaces of the teeth had decay and iron sulfate (ViscoStat®, UltraDent, South Jordan, USA) was used as pulpotomy material. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity. 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application.
An aerator and micromotor were used as cavity preparation in the restorative treatment groups. Only the micromotor was used for polishing purposes in the protective treatment groups. FIS (Facial Image Scale) was assessed at three stages: at the moment they sat in the dental chair, 15 minutes after the start of the treatment, and 15 minutes after the end of the treatment. From the moment the patient sat in the dental chair, the probe of the bed-side monitor was attached to the patient's left index finger, and his/her heart rate and SpO2 (peripheral oxygen saturation ) of were monitored during the treatment period and the data were recorded. After the treatment of the patients was completed in that appointment, the CFSS-DS (Children's Fear Survey Schedule-Dental Subscales) was filled in by the patients under the supervision of their parents. In the mornings, 3 salivary samples were taken from the patients by their parents in the home environment, i.e. one day before the treatment, on the day of treatment and one day after the treatment. The non-stimulated total saliva was collected from the patients. The parents were warned about the fact that all of the three salivary samples should be taken at the 30th minute after awakening, between 07:00 and 07:30 am. Eating, drinking, brushing the teeth and using dental care products were not allowed. During the treatment period in the clinic, salivary samples were taken between 09.00 and 11.00 am. Saliva samples were taken in 3 stages, i.e. at the beginning of the treatment, at the 15th minute of the treatment, and 15 minutes after the end of the treatment. Sampling at 15th minute of the treatment process was standardized to correspond to the cavity with an aerator (at the enamel level) in restorative treatment groups and to the stage of polishing procedure with a micro motor in protective treatment groups. These measures were taken to prevent the saliva from contaminating the cavity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment | Experimental | Procedure: Restorative TreatmentIt's one of the restorative groups with LA (Local Anesthesia). An aerator and micromotor were used as cavity preparation in this group. Only conventional root canal treatment and extirpation were planned for the children included in the root canal treatment group in the measurement session. |
| Pulpotomy treatment | Experimental | Procedure: Restorative TreatmentIt's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group. it was noted that at least one of the approximal surfaces of the teeth had decay and iron sulfate (ViscoStat®, UltraDent, South Jordan, USA) was used as pulpotomy material |
| two-surface restoration with Local Anesthesia | Experimental | Procedure: Restorative TreatmentIt's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity. |
| one surface restoration with Local Anesthesia | Experimental | Procedure: Restorative TreatmentIt's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group. |
| two-surface restoration without Local Anesthesia | Experimental | Procedure: Restorative TreatmentAn aerator and micromotor were used as cavity preparation in this group. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity. |
| one surface restoration without Local Anesthesia | Experimental | Procedure: Restorative TreatmentAn aerator and micromotor were used as cavity preparation in this group. |
| fluoride application by disposable arch tray | Experimental | Procedure: Restorative TreatmentIt's one of the protective groups.Only the micromotor was used for polishing purposes in the protective treatment groups. 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application. |
| fluoride application by cotton roll | Experimental | Procedure: Restorative TreatmentIt's one of the protective groups. Only the micromotor was used for polishing purposes in the protective treatment groups 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application. |
| Fissure Sealant group | Experimental | Procedure: Restorative TreatmentIt's one of the protective groups. Only the micromotor was used for polishing purposes in the protective treatment groups. |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- They were apparently healthy and had no previous experience of dental treatment
- In terms of the standardization of the groups, only the children who were compatible with Frankl-3 or 4 classes were included in the study.
- The patients were divided into groups taking into consideration the requirements of having no pain, abscess, fistula and no need for dental treatment requiring urgent intervention.
Key exclusion criteria (2 listed)
- Patients, who did not meet the inclusion criteria for the study, who did not want to participate voluntarily, who ate and drank something 1 hour before the appointment, who used medication in the last 7 days, who used medication that may affect the salivary flow in the last 60 days or who left the dental treatment incomplete, were not included in the study.
- Children with Farnkl-1 and -2 classes had negative compliance to treatment and therefore they were not included in 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 |
|---|---|---|
| Restorative TreatmentAlso: Protective Application9 groups were formed as 6 restorative and 3 protective applications. The restorative treatment groups included procedures with- and without-local anesthesia (LA). Procedures with LA included the groups as root canal treatment, pulpotomy, two-surface restoration and one-surface restoration. Procedures without LA included the groups as two-surface restoration and one-surface restoration. The protective application groups included the groups as fluoride application (by disposable arch tray or by cotton roll) and fissure sealant. | Procedure or surgery | Fissure Sealant group, Pulpotomy treatment, Root canal treatment, fluoride application by cotton roll, fluoride application by disposable arch tray, one surface restoration with Local Anesthesia, one surface restoration without Local Anesthesia, two-surface restoration with Local Anesthesia, two-surface restoration without Local Anesthesia |
Primary outcome
Salivary cortisol levels at home
Time frame: 30th minute after awakening, between 07:00 and 07:30 am.
the day before treatment
Salivary cortisol levels at home
Time frame: 30th minute after awakening, between 07:00 and 07:30 am.
the treatment day
Salivary cortisol levels at home
Time frame: 30th minute after awakening, between 07:00 and 07:30 am.
the day after treatment
Salivary cortisol levels at clinic
Time frame: beginning of the treatment, between 09:00 and 11:00 am.
the treatment day
Salivary cortisol levels in clinic
Time frame: 15th minute of the treatment, between 09:00 and 11:00 am.
the treatment day
Salivary cortisol levels in clinic
Time frame: 15th minute post treatment, between 09:00 and 11:00 am.
the treatment day
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 8 Apr 2020.
- Results publication: PubMed 24766350Yfanti K, Kitraki E, Emmanouil D, Pandis N, Papagiannoulis L. Psychometric and biohormonal indices of dental anxiety in children. A prospective cohort study. Stress. 2014 Jul;17(4):296-304. doi: 10.3109/10253890.2014.918602. Epub 2014 May 27.
- 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.
Burçin Acar, Dr principal investigator
Inonu University
Gulsum Duruk, Dr study director
Inonu University
Sedat Yildiz, Prof. study chair
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restorative Treatment in people with Dental Anxiety, run by Inonu 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 3 inclusion and 2 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 8 Apr 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?
Salivary cortisol levels at home (time frame: 30th minute after awakening, between 07:00 and 07:30 am.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338854, which also lists 1 linked publication.
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 8 Apr 2020.