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

NCT07462598 | Completed

• 1 other identifier: 123456
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parodontopathy

Outcome Measures

Primary Outcomes (3)

• Patient Reported postoperative pain andswelling

  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

  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

  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 Outcomes (1)

• Patient experience with analgosedation

  "From enrollment to the end of treatment at 3 days"

Study Arms (1)

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

Procedure: Full arch rehabilitation with four dental implants

Interventions

Full arch rehabilitation with four dental implants PROCEDURE

The elective full-arch rehabilitation using the All-on-Four protocol under analgosedation

Analgosedation

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Emergency dental or surgical intervention
• Pregnancy
• Patients with cognitive impairment or psychiatric conditions affecting reliable outcome reporting
• Patients with contraindications to analgo-sedation

Sponsors & Collaborators

• University of Zagreb: lead
• St. Catherine Specialty Hospital: collaborator

Study Sites (1)

Dental Center, St.Caherine Hospital

Zagreb, Croatia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sinior assistant at Department of Oral Surgery

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 10, 2026
• Study Start: January 1, 2026
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1.1.2027 till 31.12.2027

Locations

CR (1)