Dental AnxietyNCT04037930
Cardiovascular Response in Implant Surgery
An observational study of Dental Anxiety and Cardiovascular Abnormalities, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to observe the level of anxiety and its relationship with cardiovascular changes in each implant. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Cardiovascular Abnormalities
- What is being tested?
- multiple implant surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2019to 15 Nov 2019
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 patients over the age of 30 undergoing elective dental implant surgery
Who may be able to join
- Over 30
- 4 years and older implant in the same session
Who cannot join
- patients with syndrome,
- having systemic disease,
- having heart problems,
- undergo another oral or maxillofacial procedure in the last 6 months,
- using medications that may cause changes in medical conditions and heart rate,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Cardiovascular Response and Dental Anxiety in Multiple Implant Surgery
The aim of this study was to observe the level of anxiety and its relationship with cardiovascular changes in each implant.
- Conditions
- Dental Anxiety, Cardiovascular Abnormalities
- Being tested
- multiple implant surgery
- Medical subject headings
- Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple implant surgeryBehavioural
Patients older than 30 years who will undergo elective dental implant surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
cardiovascular changes in implant surgery
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start15 Jul 2019
- Primary completion15 Oct 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
- Investigators
- ilke kupeli, Principal investigator, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037930
- Sponsor's protocol ID
- erzincan binali yıldırım ç
- Status last verified
- Jul 2019
- First submitted
- 28 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Corah NL. Development of a dental anxiety scale. J Dent Res. 1969 Jul-Aug;48(4):596. doi: 10.1177/00220345690480041801. No abstract available.
PubMed 5256508CANDIDO, Milene Cardoso, et al. Clinical setting influences physiological responses in dental implant patients. Brazilian Journal of Oral Sciences, 2014, 13.2: 109-113.
Newton JT, Buck DJ. Anxiety and pain measures in dentistry: a guide to their quality and application. J Am Dent Assoc. 2000 Oct;131(10):1449-57. doi: 10.14219/jada.archive.2000.0056.
PubMed 11042984Nagao H, Munakata M, Tachikawa N, Shiota M, Kasugai S. [Clinical study of risk management for dental implant treatment--changes of blood pressure and pulse rate during implant surgery under local anesthesia]. Kokubyo Gakkai Zasshi. 2002 Mar;69(1):27-33. doi: 10.5357/koubyou.69.27. Japanese.
PubMed 11968835
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cardiovascular Response and Dental Anxiety in Multiple Implant Surgery
- ClinicalTrials.gov ID
- NCT04037930
- Acronym / sponsor ID
- erzincan binali yıldırım ç
- Conditions
- Dental Anxiety, Cardiovascular Abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 30 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.
The aim of this study was to observe the level of anxiety and its relationship with cardiovascular changes in each implant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients over the age of 30 undergoing elective dental implant surgery
Key inclusion criteria (2 listed)
- Over 30
- 4 years and older implant in the same session
Key exclusion criteria (5 listed)
- patients with syndrome,
- having systemic disease,
- having heart problems,
- undergo another oral or maxillofacial procedure in the last 6 months,
- using medications that may cause changes in medical conditions and heart rate,
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 |
|---|---|---|
| multiple implant surgeryPatients older than 30 years who will undergo elective dental implant surgery. | Behavioural | – |
Primary outcome
Heart rate
Time frame: 4 months
cardiovascular changes in implant surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Background: PubMed 5256508Corah NL. Development of a dental anxiety scale. J Dent Res. 1969 Jul-Aug;48(4):596. doi: 10.1177/00220345690480041801. No abstract available.
- Results publicationCANDIDO, Milene Cardoso, et al. Clinical setting influences physiological responses in dental implant patients. Brazilian Journal of Oral Sciences, 2014, 13.2: 109-113.
- Results publication: PubMed 11042984Newton JT, Buck DJ. Anxiety and pain measures in dentistry: a guide to their quality and application. J Am Dent Assoc. 2000 Oct;131(10):1449-57. doi: 10.14219/jada.archive.2000.0056.
- Results publication: PubMed 11968835Nagao H, Munakata M, Tachikawa N, Shiota M, Kasugai S. [Clinical study of risk management for dental implant treatment--changes of blood pressure and pulse rate during implant surgery under local anesthesia]. Kokubyo Gakkai Zasshi. 2002 Mar;69(1):27-33. doi: 10.5357/koubyou.69.27. Japanese.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Anxiety
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
Not yet recruiting
Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children
Dental Anxiety in Children
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
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.
ilke kupeli principal investigator
Erzincan 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 Dental Anxiety and Cardiovascular Abnormalities, run by Erzincan 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 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: status not confirmed, as of the sponsor's last update on 30 Jul 2019. 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?
Results are not available in the source record.
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?
Heart rate (time frame: 4 months). 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 NCT04037930, which also lists 4 linked publications.
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 30 Jul 2019.