Back to resultsEvaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine
Primary Purpose
Impacted Third Molar Tooth
Status
Active
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Rifamycine
Saline Solution
Sponsored by
About this trial
This is an interventional prevention trial for Impacted Third Molar Tooth focused on measuring rifamycine, pain, edema, trismus
Eligibility Criteria
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
Sites / Locations
- Van Yuzuncu Yil University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rifamycine
Saline
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Postoperative Pain
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).
Postoperative Pain
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).
Postoperative Swelling
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 Trismus
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 Pain
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).
Postoperative Pain
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).
Postoperative Pain
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).
Postoperative Pain
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).
Postoperative Pain
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).
Postoperative Swelling
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 Trismus
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04349579
Brief Title
Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine
Official Title
Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine on Postoperative Pain, Edema and Trismus in Impacted Lower Third Molar Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
rifamycine, pain, edema, trismus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rifamycine
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rifamycine
Other Intervention Name(s)
RIF 250 MG IM Ampul
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Other Intervention Name(s)
KANFLEKS % 0,9 IZOTONIK SODYUM KLORUR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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).
Time Frame
Postoperatif 1st day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperatif 2nd day
Title
Postoperative Swelling
Description
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.
Time Frame
Postoperative 2nd day
Title
Postoperative Trismus
Description
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.
Time Frame
Postoperative 2nd day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperatif 3th day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperatif 4th day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperatif 5th day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperatif 6th day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperatif 7th day
Title
Postoperative Swelling
Description
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.
Time Frame
Postoperative 7th day
Title
Postoperative Trismus
Description
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.
Time Frame
Postoperative 7th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap KESKIN TUNC, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Van Yuzuncu Yil University, Faculty of Dentistry
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine
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