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

Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine on Postoperative Pain, Edema and Trismus in Impacted Lower Third Molar Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04349579
Enrollment
35
Registered
2020-04-16
Start date
2018-11-15
Completion date
2023-12-15
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth

Keywords

rifamycine, pain, edema, trismus

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.

Interventions

DRUGRifamycine

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.

DRUGSaline Solution

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.

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative PainPostoperatif 1st dayPatients 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 SwellingPostoperative 2nd dayPostoperative 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 TrismusPostoperative 2nd dayPostoperative 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026