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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05860686
Other study ID # NL81366.075.22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date May 1, 2024

Study information

Verified date May 2023
Source Isala
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date May 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Monoject syringe
monoject syringe is used to clean the wound

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Isala

Outcome

Type Measure Description Time frame Safety issue
Primary NRS pain pain score 7 days after treatment
See also
  Status Clinical Trial Phase
Completed NCT04143373 - Effect of Warm Saline Irrigation on Bleeding in Mandibular Third Molar Surgery N/A
Completed NCT03501225 - Effects of Ozonated Water on Pain, Swelling, Trismus and Quality of Life in Third Molar Surgery N/A
Completed NCT04641533 - Effect of Dental Pulp Stem Cells and L-PRF After Impacted Third Molar Extraction N/A
Completed NCT05744882 - The Need Of Root Canal Treatment After Coronectomy In Mandibular Third Molars N/A
Completed NCT05044481 - "Impact of the Third Molars in Oral Health-related Quality of Life"
Completed NCT02696369 - Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars Phase 4
Completed NCT03130933 - Complications After Lower Third Molar Surgery Phase 1/Phase 2
Active, not recruiting NCT03398382 - Effect of Oral Magnesium on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars. Phase 1/Phase 2