- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04349579
Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine
August 20, 2023 updated by: levent Cigerim, Yuzuncu Yıl University
Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine on Postoperative Pain, Edema and Trismus in Impacted Lower Third Molar Surgery
Removal of impacted lower third molar teeth is one of the most common oral surgical procedures, and these operations often lead to various complications in patients.
Antibiotics, analgesics and mouthwashes are prescribed for the treatment of complications encountered.
When using postoperative antibiotics in surgery of impacted third molar teeth, lower surgical area infection, pain, swelling and trismus are seen.
Based on this information, in this study, it is aimed to evaluate the effects of rifamycine intraoperatively on the postoperative pain, swelling and trismus.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tuşba
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Van, Tuşba, Turkey, 65080
- Van Yuzuncu Yil University, Faculty of Dentistry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- absence of any systemic disease
- having bilateral impacted mandibular third molar teeth in a similar position
- absence of allergy to any of the drugs used in the study,
- absence of pregnancy/lactating state,
- no history of any medication use during at least 2 week before the operation.
Exclusion Criteria:
- not regularly coming to the controls,
- not using their medicines regularly
- using any additional medication that may affect the outcome of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rifamycine
Rifamycine is a broad spectrum semi-synthetic antibiotic that acts on gram-positive and gram-negative microorganisms.
As a local application, it has areas of use in dentistry such as washing fistula mouths, maxillary sinus and abscess wounds and treating osteomyelitis.
|
Local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml .
The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised.
In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation.
Following the extraction, granulation tissues were removed, and bleeding was controlled.
Finally, extraction socket was irrigated with the solution which contains 250 mg rifamycine and the mucoperiosteal flap was repositioned by 3.0 silk sutures.
Other Names:
|
Active Comparator: Saline
Saline, also known as saline solution, is a mixture of sodium chloride in water and has a number of uses in medicine.
Applied to the affected area it is used to clean wounds.
It is also used to dilute other drugs to be injected and to wash the operation site in dental surgery operations.
It is most commonly used as a sterile 9 g of salt per litre (0.9%) solution, known as normal saline.
|
Local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml .
The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised.
In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation.
Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with saline solution.
After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Pain
Time Frame: Postoperatif 1st day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperatif 1st day
|
Postoperative Pain
Time Frame: Postoperatif 2nd day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperatif 2nd day
|
Postoperative Swelling
Time Frame: Postoperative 2nd day
|
Postoperative swelling was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.
|
Postoperative 2nd day
|
Postoperative Trismus
Time Frame: Postoperative 2nd day
|
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
|
Postoperative 2nd day
|
Postoperative Pain
Time Frame: Postoperatif 3th day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperatif 3th day
|
Postoperative Pain
Time Frame: Postoperatif 4th day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperatif 4th day
|
Postoperative Pain
Time Frame: Postoperatif 5th day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperatif 5th day
|
Postoperative Pain
Time Frame: Postoperatif 6th day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperatif 6th day
|
Postoperative Pain
Time Frame: Postoperatif 7th day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperatif 7th day
|
Postoperative Swelling
Time Frame: Postoperative 7th day
|
Postoperative swelling was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.
|
Postoperative 7th day
|
Postoperative Trismus
Time Frame: Postoperative 7th day
|
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
|
Postoperative 7th day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Serap KESKIN TUNC, PhD, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2018
Primary Completion (Estimated)
December 15, 2023
Study Completion (Estimated)
December 15, 2023
Study Registration Dates
First Submitted
April 12, 2020
First Submitted That Met QC Criteria
April 14, 2020
First Posted (Actual)
April 16, 2020
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 20, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19.07.2017/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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