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CompletedNCT06900907Updated Mar 28, 2025

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

An interventional study of Diode laser and Hyaluronic acid in Tooth Impaction | {Tooth} | Dental, Corticosteroid and Hyaluronic Acid, sponsored by Batman University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by Batman University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years after the study started (first participant enrolled Mar 2017, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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03

In context

Tooth, Impacted

122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.

This study's enrollment of 75 is close to the median of 70 across 88 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Batman University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients classified as (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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • Active comparator
    Group 5 Control

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

    Procedure: Control

Interventions

  • DeviceDiode laser

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

    Also known as: Epic X, Biolase, USA

  • Combination productHyaluronic acid

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

    Also known as: Aftamed ®

  • Combination productOzone

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

    Also known as: W&H Prozone Ozone Generator

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

    Also known as: Precort 4 mg Tablet

  • ProcedureControl

    Only the standard prescribed medication was provided.

06

What researchers measure

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)

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

Secondary outcomes

  1. Edema

    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

    Time frame: 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

    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.

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

07

Study locations

1 site
  • Dicle University
    Diyarbakır, Sur 21280, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06900907
Lead sponsor
Batman University
Responsible party
Rojdan Ferman GÜNEŞ UYSAL (Assistant professor, Batman University) — Principal investigator
First posted
Mar 28, 2025
Start date
Mar 1, 2017
Primary completion
Aug 30, 2017
Completion
Sep 22, 2017
Last update
Mar 28, 2025

Study contacts

Nedim GÜNEŞ, Ass.Prof.
study chair · Dicle University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Hyaluronic Acid · Ozone · Methylprednisolone

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