- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462598
Patient Satisfaction and Postoperative Outcomes Following All-on-Four Implant Surgery Under Analgosedation
Patient Satisfaction and Postoperative Outcomes Following All-on-Four Implant Surgery Under Analgosedation: A Prospective Study
Objective: To evaluate patient satisfaction, postoperative pain, inflammatory re-sponse, and analgesic consumption following All-on-Four implant surgery performed under analgosedation.
Methods: This prospective clinical study will include 30 adult patients classified as ASA physical status I-II who were scheduled for elective full-arch rehabilitation using the All-on-Four protocol under analgosedation. Patients with contraindications to sedation, cognitive impairment, or emergency indications will be excluded. Postoperative pain and swelling will be assessed using a visual analogue scale (VAS) up to 72 hours. Real analgesic consumption will be recorded during the first three postoperative days. Systemic inflammatory response will be evaluated by serum C-reactive protein (CRP) levels measured preoperatively and on postoperative day 3. Patient experience with anesthetic management will be assessed using a structured questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zagreb, Croatia
- Dental Center, St.Caherine Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients scheduled for elective full-arch implant rehabilitation
- ASA physical status I or II
- Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Emergency dental or surgical intervention
- Pregnancy
- Patients with cognitive impairment or psychiatric conditions affecting reliable outcome reporting
- Patients with contraindications to analgo-sedation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Analgosedation
Adult patients classified as ASA physical status I-II who were scheduled for elective full-arch rehabilitation using the All-on-Four protocol under analgosedation
|
The elective full-arch rehabilitation using the All-on-Four protocol under analgosedation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Reported postoperative pain andswelling
Time Frame: "From enrollment to the end of treatment at 3 days"
|
The primary outcome measures included patient-reported postoperative pain and swelling, analgesic use and systemic inflammatory response. Postoperative pain intensity and swelling were assessed using a 10-point Visual Analogue Scale (VAS), where 0 indicated the absence of symptoms and 10 indicated the maximum perceived severity. Assessments were performed preoperatively and at 2, 6, 12, 24, 48, and 72 hours postoperatively. |
"From enrollment to the end of treatment at 3 days"
|
|
Rescue analgesic consumption
Time Frame: From surgery up to 3rd postoperative day
|
Rescue analgesic consumption was recorded for each patient during the first three postoperative days and quantified based on the total number of tablets consumed and daily dose.
Analgesic intake was used as an indirect indicator of postoperative discomfort.
|
From surgery up to 3rd postoperative day
|
|
The systemic inflammatory response
Time Frame: "From enrollment to the end of treatment at 3 days"
|
To evaluate the systemic inflammatory response, serum C-reactive protein (CRP) levels were measured preoperatively and on postoperative day 3 using standard laboratory procedures.
|
"From enrollment to the end of treatment at 3 days"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient experience with analgosedation
Time Frame: "From enrollment to the end of treatment at 3 days"
|
All patients were asked to complete a structured questionnaire assessing their experience with anesthetic management.
The questionnaire collected demographic data and medical history, and included items related to previous exposure to analgosedation, attitudes toward different anesthesia modalities, perioperative anxiety, adequacy of preoperative information, patient involvement in anesthesia decision-making, and overall satisfaction with the anesthetic care.
In addition, patients were asked to report intraoperative and early postoperative discomfort, adverse sensations following emergence from analgosedation, and their willingness to undergo the same anesthesia protocol in the future
|
"From enrollment to the end of treatment at 3 days"
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 123456 (Innovate UK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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