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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Participants having dental surgery |
| |
| Intravenous sedation | Participants having dental surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Sedatives with or Without Analgesia | Drug | Participants having dental surgery with conscious intravenous sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure (systolic) | Systolic blood pressure will be recorded throughout the surgical procedure | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. |
| Change in blood pressure (diastolic) | Diastolic blood pressure will be recorded throughout the surgical procedure | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. |
| Change in heart rate | Heart rate will be recorded throughout the surgical procedure | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. |
| Change in oxygen saturation | Oxygen saturation will be recorded throughout the surgical procedure | At the start of surgery and every 15 minutes until the surgery is over, up to 4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Dental Anxiety Scale | Evaluation of dental anxiety using Corah's Dental Anxiety Scale. Minimum score 4, maximum score 20 with higher scores indicating greater dental anxiety. | Baseline |
| Patient Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects scheduled for dental surgery with or without intravenous sedation.
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| Name | Affiliation | Role |
|---|---|---|
| Hom-Lay Wang, DDS MSD PhD | Department of Periodontics and Oral Medicine University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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| No IV sedation | Drug | Participants having dental surgery without conscious intravenous sedation |
|
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Patient satisfaction with surgery. Minimum score 6, maximum score 30 with higher scores indicating greater satisfaction.
| 2 weeks after surgery |