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NCT Number: NCT06900907

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

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.

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Key information

Conditions

Tooth Impaction | {Tooth} | Dental Corticosteroid Hyaluronic Acid Laser Therapy Ozone Stomatognathic Diseases Tooth Diseases Tooth, Impacted

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dicle University

Diyarbakır, Sur, 21280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diode laser

Device

A single session was applied to three points of the tooth extraction site.

Other names: Epic X, Biolase, USA

Hyaluronic Acid

Combination Product

1 cc of hyaluronic acid gel was placed into the extraction socket, followed by suturing.

Other names: Aftamed ®

Ozone

Combination Product

Topical ozone was applied to the extraction socket, followed by suturing.

Other names: W&H Prozone Ozone Generator

methylprednisolone

Drug

In addition to the standard prescribed medication, 4 mg of oral methylprednisolone was prescribed postoperatively.

Other names: Precort 4 mg Tablet

Control

Procedure

Only the standard prescribed medication was provided.

Primary outcomes

  1. Trismus

    Time frame: 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 outcomes

  1. Edema

    Time frame: 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

Other outcomes

  1. Pain Level

    Time frame: All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.

    Pain levels were assessed using a visual analog scale (VAS) form, numbered from 1 to 10. For each follow-up period, patients were instructed to mark a value where 0 indicated no pain, 10 represented unbearable pain, and intermediate values reflected varying pain intensities.

Sponsors and collaborators

Lead sponsor

Batman University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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