NCT06873152

Brief Summary

This study aims to assess and compare the implementation of this comprehensive program in patients undergoing bilateral third molar extraction on OR and hospital efficiency and patient experience. The investigators hypothesize that this comprehensive program will be superior in terms of OR efficiency compared to "business as usual".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

March 5, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

operation room efficiencythird molar surgery

Outcome Measures

Primary Outcomes (1)

  • Evaluation of total operation room stay time

    Evaluation of the Total Operation room (OR) stay time defined as departure time from the OR minus arrival time in the OR

    on day of surgery, day 0

Secondary Outcomes (9)

  • Evaluation of the surgical time

    on day of surgery, day 0

  • Evaluation of Anesthesia induction time

    on day of surgery, day 0

  • Evaluation of emergence time

    on day of surgery, day 0

  • evaluation of turnover time

    on day of surgery, day 0

  • Evaluation of non operative time

    on day of surgery, day 0

  • +4 more secondary outcomes

Study Arms (2)

Control group

SHAM COMPARATOR

The operation room team will consist of a randomly planned team which may also comprise nurse trainees and/or anesthesiology residents. At arrival in the operating theatre, all patients will be placed in the supine position and receive full standard monitoring (non-invasive blood pressure monitoring, electrocardiographic monitoring, and peripheral O2 saturation monitoring). Furthermore, they will receive an intravenous access with 0.9% sodium chloride infusion and will be administered clindamycine 900mg IV.

Procedure: Control preoperative program

Experimental group

EXPERIMENTAL

All patients planned on an experimental stomatology program day will receive an intravenous access with 0.9% sodium chloride infusion at the ambulatory ward and will be administered clindamycine 900mg IV 30 minutes before the start of surgery. During an experimental stomatology program day, the OR team will consist of 2 very well-trained OR nurses who are exclusively dedicated to the maxillofacial surgery department and a highly experienced anesthesiologist who also has frequent exposure to surgical maxillofacial interventions programs. Nurse trainees and/or anesthesiology residents will not be planned in the stomatology OR on experimental days.

Procedure: Advanced preoperative program

Interventions

Patients will undergo a control preoperative program with no enhances preparation when undergoing bilateral third molar extraction

Control group

Patients will undergo an comprehensive program including enhanced preoperative preparation and a dedicated operating room team when undergoing bilateral third molar extraction

Experimental group

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: 16-60 years
  • ASA I- III
  • BMI ≤ 40 kg/m2
  • Patient is willing to give informed consent
  • Patient is scheduled for wisdom teeth surgery

You may not qualify if:

  • The inability to understand to the study design
  • Refusal to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 12, 2025

Study Start

March 10, 2025

Primary Completion

May 27, 2025

Study Completion

May 27, 2025

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations