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

NCT05860686 | Unknown DMC

• 1 other identifier: NL81366.075.22
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Third Molar

Outcome Measures

Primary Outcomes (1)

• NRS pain

  pain score

  7 days after treatment

Study Arms (2)

No rinsing

ACTIVE COMPARATOR

Other: Monoject syringe

Monoject rinsing

EXPERIMENTAL

Other: Monoject syringe

Interventions

Monoject syringe OTHER

monoject syringe is used to clean the wound

Monoject rinsing; No rinsing

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral an Maxillo facial surgeon

Model Details: Double blind randomized clinical trial

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 16, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05