NCT04037930

Brief Summary

The aim of this study was to observe the level of anxiety and its relationship with cardiovascular changes in each implant.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

July 28, 2019

Last Update Submit

July 29, 2019

Conditions

Dental AnxietyCardiovascular Abnormalities

Outcome Measures

Primary Outcomes (1)

  • Heart rate

    cardiovascular changes in implant surgery

    4 months

Interventions

multiple implant surgeryBEHAVIORAL

Patients older than 30 years who will undergo elective dental implant surgery.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 patients over the age of 30 undergoing elective dental implant surgery

You may qualify if:

  • Over 30
  • years and older implant in the same session

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan University

Erzincan, 24100, Turkey (Türkiye)

Location

Related Publications (4)

  • Corah NL. Development of a dental anxiety scale. J Dent Res. 1969 Jul-Aug;48(4):596. doi: 10.1177/00220345690480041801. No abstract available.

    PMID: 5256508BACKGROUND

  • CANDIDO, Milene Cardoso, et al. Clinical setting influences physiological responses in dental implant patients. Brazilian Journal of Oral Sciences, 2014, 13.2: 109-113.

    RESULT

  • 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.

    PMID: 11042984RESULT

  • 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.

    PMID: 11968835RESULT

MeSH Terms

Conditions

Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • ilke kupeli

    Erzincan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 28, 2019

First Posted

July 30, 2019

Study Start

July 15, 2019

Primary Completion

October 15, 2019

Study Completion

November 15, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

TU(1)