Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine

Phase 4

Active, not recruiting

• Conditions: Impacted Third Molar Tooth
• Interventions: Drug: Saline Solution; Drug: Rifamycine

• Registration Number: NCT04349579
• Lead Sponsor: Yuzuncu Yıl University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2020-04-12
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-20
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Saline	Saline Solution	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.
Rifamycine	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Trismus	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 Pain	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).
Postoperative Swelling	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.

Trial Locations

Locations (1)

Van Yuzuncu Yil University, Faculty of Dentistry; 🇹🇷 Van, Tuşba, Turkey