Patient Satisfaction and Postoperative Outcomes Following All-on-Four Implant Surgery Under Analgosedation

April 7, 2026 updated by: Igor Smojver, University of Zagreb

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zagreb, Croatia
        • Dental Center, St.Caherine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This prospective clinical study will include 30 patients classified as ASA physical status I-II who need to underwent full-arch rehabilitation using the All-on-Four implant concept

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

January 1, 2026

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)?

YES

IPD Plan Description

All data if needed.

IPD Sharing Time Frame

1.1.2027 till 31.12.2027

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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