Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation

NCT ID: NCT05756439

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-03

Study Completion Date

2022-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during periodontal/implant surgery compared to receiving local anesthesia during periodontal/implant surgery

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Monitoring is the global method of observation and data recording in relation to body organ and system function that afford constant information to ensure continuous evaluation of the patient's physical condition. The aim of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during dental surgery.

Secondary, patient related outcome will be evaluated by a questionnaire to determine the patients' perception, acceptance and comfort during intravenous sedation after assessing the influence of patients' preoperative anxiety.

50 subjects who need implant/periodontal surgery at the University of Michigan School of Dentistry will be recruited for this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Dental Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Participants having dental surgery

No IV sedation

Intervention Type DRUG

Participants having dental surgery without conscious intravenous sedation

Intravenous sedation

Participants having dental surgery

Intravenous Sedatives with or Without Analgesia

Intervention Type DRUG

Participants having dental surgery with conscious intravenous sedation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous Sedatives with or Without Analgesia

Participants having dental surgery with conscious intravenous sedation

Intervention Type DRUG

No IV sedation

Participants having dental surgery without conscious intravenous sedation

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

conscious iv sedation no conscious iv sedation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be ≥ 18 years of age
* Need dental implant/periodontal surgery with or without IV sedation (up to a maximum of 4 implants)

Exclusion Criteria

* You have any reason you cannot comply with the study protocol
* You take any medication that may influence hemodynamic changes including anxiolytic medication (last intake \<48 hours before intervention) as well as pain medication (last intake \<48 hours before intervention)
* Pregnant or unsure of pregnancy (self-reported)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hom-Lay Wang, DDS, MSD, Ph D

Collegiate Professor of Periodontics and Professor of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hom-Lay Wang, DDS MSD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontics and Oral Medicine University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUM00172521

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.