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

NCT06900907 | Completed

• 2 other identifiers: BatmanU-DF-RFGU-03DİŞ.15.023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Impaction | {Tooth} | Dental; Corticosteroid; Hyaluronic Acid; Ozone; Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Trismus

  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 Outcomes (1)

• Edema

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

Other Outcomes (1)

• Pain Level

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

Study Arms (5)

Group 1 Laser

EXPERIMENTAL

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

Group 2 Hyaluronic acid

EXPERIMENTAL

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

Group 3 Ozone

EXPERIMENTAL

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

Group 4 Methylprednisolone

EXPERIMENTAL

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

Group 5 Control

ACTIVE COMPARATOR

In Group 5 (control group), only the standard prescribed medication was provided.

Procedure: Control

Interventions

Diode laser DEVICE

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

Also known as: Epic X, Biolase, USA

Group 1 Laser

Hyaluronic acid COMBINATION_PRODUCT

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

Also known as: Aftamed ®

Group 2 Hyaluronic acid

Ozone COMBINATION_PRODUCT

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

Also known as: W&H Prozone Ozone Generator

Group 3 Ozone

Methylprednisolone DRUG

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

Also known as: Precort 4 mg Tablet

Group 4 Methylprednisolone

Control PROCEDURE

Only the standard prescribed medication was provided.

Group 5 Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Batman University: lead

Study Sites (1)

Dicle University

Diyarbakır, Sur, 21280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, Impacted

Interventions

Lasers, Semiconductor; Hyaluronic Acid; Ozone; Methylprednisolone; Tablets

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Glycosaminoglycans; Polysaccharides; Carbohydrates; Oxygen; Gases; Inorganic Chemicals; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Nedim GÜNEŞ, Ass.Prof.

  Dicle University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 28, 2025
• Study Start: March 1, 2017
• Primary Completion: August 30, 2017
• Study Completion: September 22, 2017
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)