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OpenTrials
Completed

NCT Number: NCT07462598

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

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.

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Key information

Conditions

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental Center, St.Caherine Hospital

Zagreb, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full arch rehabilitation with four dental implants

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Collaborators

  • St. Catherine Specialty Hospital

Registry information

Official study title

Patient Satisfaction and Postoperative Outcomes Following All-on-Four Implant Surgery Under Analgosedation: A Prospective Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.