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

NCT ID: NCT06900907

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-09-22

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Diode laser

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type EXPERIMENTAL

Ozone

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

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

Group 5 Control

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

Only the standard prescribed medication was provided.

Interventions

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Diode laser

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

Intervention Type DEVICE

Hyaluronic acid

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

Intervention Type COMBINATION_PRODUCT

Ozone

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

Intervention Type COMBINATION_PRODUCT

Methylprednisolone

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

Intervention Type DRUG

Control

Only the standard prescribed medication was provided.

Intervention Type PROCEDURE

Other Intervention Names

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Epic X, Biolase, USA Aftamed ® W&H Prozone Ozone Generator Precort 4 mg Tablet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Batman University

OTHER

Sponsor Role lead

Responsible Party

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Rojdan Ferman GÜNEŞ UYSAL

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nedim GÜNEŞ, Ass.Prof.

Role: STUDY_CHAIR

Dicle University

Locations

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Dicle University

Diyarbakır, Sur, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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DİŞ.15.023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BatmanU-DF-RFGU-03

Identifier Type: -

Identifier Source: org_study_id

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