COMBINED ESSENTIAL-OIL SUPPLEMENT AND ANTIBIOTIC THERAPY FOR ODONTOGENIC SOFT-TISSUE INFECTIONS: A PILOT RANDOMIZED CONTROLLED TRIAL – STUDY PROTOCOL

Authors: Ramona-Alexandra CIAUŞU, Tudor ILIE, Ovidiu MUREŞAN, Alin Stelian CIOBICA

Abstract:

Odontogenic soft-tissue infections are common and can spread rapidly if not treated properly. Systemic antibiotics and dental focus control are standard management practices. In the face of rising antimicrobial resistance, complementary techniques that could improve antibiotic efficacy are gaining popularity. Essential oils have antibacterial and anti-inflammatory effects, but clinical evidence for their oral use as adjuvant therapy is minimal.
The objective of this pilot study is to evaluate the feasibility, safety, and preliminary clinical impact of an essential-oilbased supplement given as an addition to routine antibiotic therapy in patients with odontogenic soft-tissue infections. This unicentric, randomized, open-label pilot study will enroll 40-60 adult patients with clinically established
odontogenic soft-tissue infections. Participants will be randomly assigned to receive standard antibiotic therapy, alone or in combination with an essential oil supplement, for 14 days. Clinical results, feasibility, and safety data will be evaluated at baseline, Day 7, Day 14, and Day 30. The primary outcomes are feasibility indicators (recruitment, adherence, retention) and safety. Secondary exploratory outcomes include reduced pain, inflammation management, antibiotic therapy duration, and need of additional therapies. Ethical approval will be acquired before the study begins.
Keywords: odontogenic soft-tissue infections, essential oils, antibiotic therapy.