- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04037930
Cardiovascular Response in Implant Surgery
July 29, 2019 updated by: ILKE KUPELI, Erzincan University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzincan, Turkey, 24100
- Erzincan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
100 patients over the age of 30 undergoing elective dental implant surgery
Description
Inclusion Criteria:
- Over 30
- 4 years and older implant in the same session
Exclusion Criteria:
- 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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: 4 months
|
cardiovascular changes in implant surgery
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- CANDIDO, 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.
- Nagao 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2019
Primary Completion (Anticipated)
October 15, 2019
Study Completion (Anticipated)
November 15, 2019
Study Registration Dates
First Submitted
July 28, 2019
First Submitted That Met QC Criteria
July 29, 2019
First Posted (Actual)
July 30, 2019
Study Record Updates
Last Update Posted (Actual)
July 30, 2019
Last Update Submitted That Met QC Criteria
July 29, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- erzincan binali yıldırım ç
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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