Does Post-operative Rinsing With a Monoject Syringe Result in as Much Post-operative Pain After Surgical Removal of Lower Impact Third Molars as no Post-operative Rinsing: a Randomized Controlled Equivalence Trial (RITOR)

Many authors have advocated different methods of treating alveolar osteitis. Despite many years of research, however, little progress has been made and so a study with large enough sample and standard outcome measures is warranted.

Goal of this study is assess the effect of postoperative use of a monoject syringe on postoperative complaints after surgical removal of a lower third molar.

Study Overview

• Status: Not yet recruiting
• Conditions: Third Molar
• Intervention / Treatment: Other: Monoject syringe

Detailed Description

One of the most common postoperative complications after the removal of a third molar is a condition known as dry socket. This term has been in use since 1896. Since then several other terms have been used, including alveolar osteitis, postoperative alveolitis, alveolitis, sicca dolorosa and fibriniolytic alveolitis. Bim labelled the complication fibrinolytic alveolitis which is the most accurate of the terms, but also the least used. The condition has generally been characterised by delayed healing associated with degradadtion of clot, and is usually accompanied by persistent, radiating, pain postoperativively in and around the extraction site that is not easily relieved by analgesics. Because of the pain, swelling and trismus, patients also tend to have a greater need for painkillers. If it is possible to reduce the amount and severity of postoperative pain felt by patients the postoperative period would be more endurable, the quality of life will be less affected, and in addition to this it is possible that the amount of analgesics taken by patients after surgery could be lowered7. It can be a burden for both patients an surgeons and my result in a loss of productivity because at least 45% of patients require multiple visits to the surgeon.

Objective of the study:

Many authors have advocated different methods of treating alveolar osteitis. Despite many years of research, however, little progress has been made and so a study with large enough sample and standard outcome measures is warranted.

Goal of this study is assess the effect of postoperative use of a monoject syringe on postoperative complaints after surgical removal of a lower third molar

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria: patients over 18 years of age (non-smoking) referred for removal of a wisdom tooth in the mandible. Patient has ASA I.

Exclusion Criteria:

• Patient is younger than 18 years

Patient has an ASA of II,III en IV

Patient has only one maxillary third molar that needs to be extracted/removed

Patient has an active pericoronitis

In case of planned coronectomy

Patient has trismus

Patient has chronic pain

Patient is pregnant

Patient has a known allergy for ibuprofen of other NSAID's

Patient has a known allergy for articaine of epinefrine

Intra-operative compilations for example excessive bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No rinsing	Other: Monoject syringe; monoject syringe is used to clean the wound
Experimental: Monoject rinsing	Other: Monoject syringe; monoject syringe is used to clean the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS pain	pain score	7 days after treatment

Collaborators and Investigators

• Sponsor: Isala

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: NL81366.075.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No