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

March 22, 2025 updated by: Rojdan Ferman GÜNEŞ UYSAL, Batman University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sur
      • Diyarbakır, Sur, Turkey, 21280
        • Dicle University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 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.
Device: Diode laser
A single session was applied to three points of the tooth extraction site.
Other Names:
  • Epic X, Biolase, USA
Experimental: Group 2 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.
Combination product: Hyaluronic acid
1 cc of hyaluronic acid gel was placed into the extraction socket, followed by suturing.
Other Names:
  • Aftamed ®
Experimental: Group 3 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.
Combination product: Ozone
Topical ozone was applied to the extraction socket, followed by suturing.
Other Names:
  • W&H Prozone Ozone Generator
Experimental: Group 4 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.
Drug: Methylprednisolone
In addition to the standard prescribed medication, 4 mg of oral methylprednisolone was prescribed postoperatively.
Other Names:
  • Precort 4 mg Tablet
Active Comparator: Group 5 Control
In Group 5 (control group), only the standard prescribed medication was provided.
Procedure: Control
Only the standard prescribed medication was provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Batman University

Investigators

  • Study Chair: Nedim GÜNEŞ, Ass.Prof., Dicle University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

September 22, 2017

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

March 22, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BatmanU-DF-RFGU-03
  • DİŞ.15.023 (Other Grant/Funding Number: Dicle University Scientific Research Projects Coordination)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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