Third MolarRITORNCT05860686
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
A study testing Monoject syringe in people with Third Molar, run by Isala.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Third Molar
- What is being tested?
- Monoject syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 May 2024
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
About this 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.
Read the 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
- Conditions
- Third Molar
- Being tested
- Monoject syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoject syringeOther
monoject syringe is used to clean the wound
| Study group | Role | What they receive |
|---|---|---|
| No rinsing | Active comparator | Not described Receives: Other: Monoject syringe |
| Monoject rinsing | Experimental | Not described Receives: Other: Monoject syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain
pain score
Measured: 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third MolarStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen van der Sleen, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860686
- Sponsor's protocol ID
- NL81366.075.22
- Acronym
- RITOR
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05860686
- Acronym / sponsor ID
- RITOR / NL81366.075.22
- Conditions
- Third Molar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 16 May 2023 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| No rinsing | Active comparator | Other: Monoject syringe |
| Monoject rinsing | Experimental | Other: Monoject syringe |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Monoject syringemonoject syringe is used to clean the wound | Other | Monoject rinsing, No rinsing |
Primary outcome
NRS pain
Time frame: 7 days after treatment
pain score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Monoject syringe in people with Third Molar, run by Isala.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
NRS pain (time frame: 7 days after treatment). 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 16 May 2023.