Tooth Impaction | {Tooth} | DentalNCT06900907
Comparison of the Effects of Protocols Applied After Surgical Extraction of Impacted Mandibular Third Molars
A study testing Diode laser, Hyaluronic acid and Ozone in people with Tooth Impaction | {Tooth} | Dental and Corticosteroid, run by Batman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Impaction | {Tooth} | Dental, Corticosteroid, Hyaluronic Acid
- What is being tested?
- Diode laser, Hyaluronic acid and Ozone
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 22 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Tooth Impaction | {Tooth} | Dental, Corticosteroid, Hyaluronic Acid, Ozone, Laser Therapy
- Being tested
- Diode laser, Hyaluronic acid, Ozone, Methylprednisolone, Control
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
Also called Epic X, Biolase, USA
A single session was applied to three points of the tooth extraction site.
Hyaluronic acidCombination product
Also called Aftamed ®
1 cc of hyaluronic acid gel was placed into the extraction socket, followed by suturing.
OzoneCombination product
Also called W&H Prozone Ozone Generator
Topical ozone was applied to the extraction socket, followed by suturing.
Also called Precort 4 mg Tablet
In addition to the standard prescribed medication, 4 mg of oral methylprednisolone was prescribed postoperatively.
ControlProcedure or surgery
Only the standard prescribed medication was provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Methylprednisolone |
| Group 5 Control | Active comparator | In Group 5 (control group), only the standard prescribed medication was provided. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Mar 2017
- Primary completion30 Aug 2017
- Study completion22 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Impaction | {Tooth} | DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rojdan Ferman GÜNEŞ UYSAL, Batman University
- Investigators
- Nedim GÜNEŞ, Ass.Prof., Study chair, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900907
- Sponsor's protocol ID
- BatmanU-DF-RFGU-03
- Other IDs
- DİŞ.15.023
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06900907
- Acronym / sponsor ID
- BatmanU-DF-RFGU-03
- Conditions
- Tooth Impaction | {Tooth} | Dental, Corticosteroid, Hyaluronic Acid, Ozone, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 22 Sep 2017 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 Laser | Experimental | Device: Diode laserIn 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 2 Hyaluronic acid | Experimental | Combination Product: Hyaluronic acidIn 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 3 Ozone | Experimental | Combination Product: OzoneIn 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 4 Methylprednisolone | Experimental | Drug: MethylprednisoloneIn 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 5 Control | Active comparator | Procedure: ControlIn Group 5 (control group), only the standard prescribed medication was provided. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode laserAlso: Epic X, Biolase, USAA single session was applied to three points of the tooth extraction site. | Device | Group 1 Laser |
| Hyaluronic acidAlso: Aftamed ®1 cc of hyaluronic acid gel was placed into the extraction socket, followed by suturing. | Combination product | Group 2 Hyaluronic acid |
| OzoneAlso: W&H Prozone Ozone GeneratorTopical ozone was applied to the extraction socket, followed by suturing. | Combination product | Group 3 Ozone |
| MethylprednisoloneAlso: Precort 4 mg TabletIn addition to the standard prescribed medication, 4 mg of oral methylprednisolone was prescribed postoperatively. | Drug | Group 4 Methylprednisolone |
| ControlOnly the standard prescribed medication was provided. | Procedure or surgery | Group 5 Control |
Primary outcome
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)
1 secondary outcome
Edema
Time frame: All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nedim GÜNEŞ, Ass.Prof. study chair
Dicle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser, Hyaluronic acid and Ozone in people with Tooth Impaction | {Tooth} | Dental and Corticosteroid, run by Batman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trismus (time frame: All patient data were collected on the 3rd and 7th postoperative days by a researcher blinded to the study groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.