Comparison of the Effects of Protocols Applied After Surgical Extraction of Impacted Mandibular Third Molars

Not Applicable

Completed

• Conditions: Tooth Impaction | {Tooth} | Dental; Corticosteroid; Hyaluronic Acid; Ozone; Laser Therapy
• Interventions: Device: Diode laser; Combination Product: Hyaluronic acid; Combination Product: Ozone; Drug: Methylprednisolone; Procedure: Control

• Registration Number: NCT06900907
• Lead Sponsor: Batman University

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-08-30
• Study Completion: 2017-09-22
• Status Verified: 2025-03
• Study First Submitted: 2025-03-22
• Study First Submitted QC: 2025-03-22
• Last Update Submitted: 2025-03-22
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 Laser	Diode laser	In Group 1, after the extraction of the impacted third molar, a diode laser (Epic X, Biolase, USA) with a wavelength of 940 nm and power of 0.2 W was applied in non-contact mode for 25 seconds at an energy density of 10 J/cm² to the occlusal, buccal, and lingual surfaces of the extraction site.
Group 2 Hyaluronic acid	Hyaluronic acid	In Group 2, after the extraction of the impacted third molar, 1 cc of high-molecular-weight hyaluronic acid gel (240 mg/100 g) (Bioplax, London, UK) was placed into the extraction socket.
Group 3 Ozone	Ozone	In Group 3, after the extraction of the impacted third molar, topical ozone therapy (W\&H Prozone Ozone Generator) was applied to the extraction socket for 15 seconds.
Group 4 Methylprednisolone	Methylprednisolone	In Group 4, in addition to the standard prescribed medication, patients received 4 mg oral methylprednisolone (Koçak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul) starting immediately after surgery. It was administered three times on the first day, twice on the second day, and once on the third day.
Group 5 Control	Control	In Group 5 (control group), only the standard prescribed medication was provided.

Primary Outcome Measures

Name	Time	Method
Trismus	All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.	Preoperative maximum mouth opening for trismus (measured as the distance between the upper right and lower right central incisors) was recorded using a Vernier caliper (Mayerbach M003, Germany)

Secondary Outcome Measures

Name	Time	Method
Edema	All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.	For edema assessment, a widely used method in the literature was applied, measuring the linear distances between the lateral canthus-gonion, tragus-pogonion, and tragus-labial commissure points using a flexible measuring tape in direct contact with the skin

Trial Locations

Locations (1)

Dicle University; 🇹🇷 Diyarbakır, Sur, Turkey