Cardiovascular Response in Implant Surgery | NCT04037930

Studies
Cardiovascular Response in Implant Surgery

NCT04037930

Sponsor

Erzincan University

Status

Unknown status

Last Update Posted

Jul 30, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Dental Anxiety
Cardiovascular Abnormalities

Interventions

multiple implant surgery

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2019Actual

Primary Completion Date

Oct 15, 2019Estimated

Completion Date

Nov 15, 2019Estimated

First Submitted Date

Jul 28, 2019

First Submission Date that Met QC Criteria

Jul 29, 2019

First Posted Date

Jul 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2019

Last Update Posted Date

Jul 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multiple implant surgery	Behavioral	Patients older than 30 years who will undergo elective dental implant surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate	cardiovascular changes in implant surgery	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ilke kupeli	Erzincan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erzincan University		Erzincan		24100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation
5256508	Background	Corah NL. Development of a dental anxiety scale. J Dent Res. 1969 Jul-Aug;48(4):596. doi: 10.1177/00220345690480041801. No abstract available.
	Result	CANDIDO, Milene Cardoso, et al. Clinical setting influences physiological responses in dental implant patients. Brazilian Journal of Oral Sciences, 2014, 13.2: 109-113.
11042984

ID	Term
D002318	Cardiovascular Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities