ParodontopathyNCT07462598
Patient Satisfaction and Postoperative Outcomes Following All-on-Four Implant Surgery Under Analgosedation
An observational study of Parodontopathy, run by University of Zagreb at 1 site in Croatia.
Trial summary
Objective: To evaluate patient satisfaction, postoperative pain, inflammatory re-sponse, and analgesic consumption following All-on-Four implant surgery performed under analgosedation. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parodontopathy
- What is being tested?
- Full arch rehabilitation with four dental implants
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2026to 1 Apr 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Emergency dental or surgical intervention
- Pregnancy
- Patients with cognitive impairment or psychiatric conditions affecting reliable outcome reporting
- Patients with contraindications to analgo-sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parodontopathy
- Being tested
- Full arch rehabilitation with four dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full arch rehabilitation with four dental implantsProcedure or surgery
The elective full-arch rehabilitation using the All-on-Four protocol under analgosedation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Full arch rehabilitation with four dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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.
Measured: 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.
Measured: "From enrollment to the end of treatment at 3 days"
Secondary outcomes (1)
Patient experience with analgosedation
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
Measured: "From enrollment to the end of treatment at 3 days"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Jan 2026
- Primary completion31 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParodontopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- St. Catherine Specialty Hospital
- Responsible party
- Principal investigator, Igor Smojver, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462598
- Sponsor's protocol ID
- 123456
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data if needed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Postoperative Outcomes Following All-on-Four Implant Surgery Under Analgosedation: A Prospective Study
- ClinicalTrials.gov ID
- NCT07462598
- Acronym / sponsor ID
- 123456
- Conditions
- Parodontopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- St. Catherine Specialty Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Analgosedation | – | Procedure: Full arch rehabilitation with four dental implantsAdult patients classified as ASA physical status I-II who were scheduled for elective full-arch rehabilitation using the All-on-Four protocol under analgosedation |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Emergency dental or surgical intervention
- Pregnancy
- Patients with cognitive impairment or psychiatric conditions affecting reliable outcome reporting
- Patients with contraindications to analgo-sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full arch rehabilitation with four dental implantsThe elective full-arch rehabilitation using the All-on-Four protocol under analgosedation | Procedure or surgery | Analgosedation |
Primary outcome
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.
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.
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.
1 secondary outcome
Patient experience with analgosedation
Time frame: "From enrollment to the end of treatment at 3 days"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. All data if needed.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parodontopathy, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported postoperative pain andswelling (time frame: "From enrollment to the end of treatment at 3 days"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.