Clinical trial NCT06900907: Comparison of the Effects of Protocols Applied After Surgical Extraction of Impacted Mandibular Third Molars
Official title: Comparison of the Effects of Ozone Therapy, Hyaluronic Acid, Methylprednisolone, and Low-Level Laser Therapy on Pain, Edema, and Trismus Following Surgical Extraction of Impacted Lower Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Impaction &#X7C; {Tooth} &#X7C; Dental
Corticosteroid
Hyaluronic Acid
Ozone
Laser Therapy
Lead sponsor: Batman University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following the surgical extraction of the most commonly impacted mandibular third molars, the first group was planned to receive methylprednisolone, the second group hyaluronic acid, the third group ozone therapy, the fourth group laser application, and the fifth group only the routine treatment protocol. The study comparatively evaluated the effectiveness of these five groups in preventing complications such as pain, edema, and trismus that may develop after impacted third molar surgery.

Detailed description: The mandibular third molars are the most commonly impacted teeth in the jaws, and their surgical extraction is a frequently performed procedure in oral and maxillofacial surgery clinics. Postoperative pain, trismus, and edema, particularly within the first 48 hours after surgery, significantly impair patients' quality of life. In addition to routinely prescribed medications, various postoperative treatment methods have been explored to minimize or control these complications. Some of the methods reported in the literature include corticosteroid administration, low-level laser therapy, hyaluronic acid application at the extraction site, and ozone therapy.

Corticosteroids exert their anti-inflammatory effects by inhibiting both the function and production of certain inflammatory cells. Therefore, they have been widely used for many years to reduce complications following impacted third molar surgery. Low-level laser therapy (LLLT) has anti-inflammatory and analgesic properties, as well as a biostimulatory effect that promotes wound healing. Ozone therapy, due to its antibacterial and anti-inflammatory properties, as well as its ability to accelerate epithelial healing, has been recognized in the literature as a modern, drug-free alternative for managing postoperative complications.

Hyaluronic acid (HA) is a member of the glycosaminoglycan family found in various body tissues. Due to its numerous advantages, including the promotion of wound healing, anti-inflammatory, bacteriostatic, and osteoinductive effects, it plays a crucial role in tissue healing and the prevention of postoperative sequelae.

This study comparatively evaluates the efficacy of low-level laser therapy, hyaluronic acid, ozone therapy, and methylprednisolone in preventing complications such as pain, edema, and trismus following impacted mandibular third molar surgery, with the aim of improving patients' quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients classified as American Society of Anesthesiologists (ASA) Class I or II
* Age range of 18-35 years
* Individuals of both genders
* Horizontally impacted teeth with the same angulation according to Winter's classification

Exclusion Criteria:

* Patients with any pathological condition around the impacted tooth
* Pregnant or breastfeeding women
* Smokers
* Individuals with allergic reactions to the adjuvants or prescribed medications used in the study
* Surgical extraction procedures exceeding 30 minutes

Primary outcomes:
measure: Trismus
timeFrame: All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.
Secondary outcomes:
measure: Edema
timeFrame: All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.
Other outcomes:
measure: Pain Level
timeFrame: All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.
Locations:
city: Diyarbakır
country: Turkey
facility: Dicle University
state: Sur
Study officials:
affiliation: Dicle University
name: Nedim GÜNEŞ, Ass.Prof.
role: STUDY_CHAIR
References: