Impacted Mandibular Third MolarNCT07297043
Efficacy of Er:YAG Laser in Removing Impacted Mandibular Third Molars
A study testing Er:YAG laser and Conventional Rotary Instruments Surgery in people with Impacted Mandibular Third Molar, run by Alexandria University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate the efficacy of the Er:YAG laser in the removal of impacted mandibular third molars compared to the conventional surgical technique. The study assesses surgical efficiency, postoperative pain, swelling, trismus, and overall patient recovery. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Impacted Mandibular Third Molar
- What is being tested?
- Er:YAG laser and Conventional Rotary Instruments Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2024to 29 Jan 2025
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Adults aged 20-30 years requiring surgical extraction of a mesioangular impacted mandibular third molar.
- Healthy individuals with no systemic diseases that may influence bone metabolism or wound healing.
- Good oral hygiene and absence of local infection at the surgical site.
- No contraindications to local anesthesia, surgical extraction, or use of the Er:YAG laser.
- Radiographic evidence confirming normal bone structure without cysts or pathological lesions.
- Willingness to participate and ability to provide informed consent.
Who cannot join
- • Systemic medical conditions affecting bone healing or postoperative response (e.g., uncontrolled diabetes, immunodeficiency, metabolic bone disorders).
- Current or recent use of medications influencing bone remodeling (e.g., bisphosphonates, corticosteroids, immunosuppressants).
- Heavy smoking (>10 cigarettes/day).
- Pregnant or breastfeeding females.
- Poor oral hygiene, active infection, or pericoronitis at the surgical site.
- Previous surgery, trauma, or pathology in the mandibular third molar region.
- Known allergies or contraindications to any material or procedure used in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate
About this study
Official title: Efficacy of Er:YAG Laser in Removal of Impacted Mandibular Third Molars (A Randomized Controlled Clinical Trial)
This randomized controlled clinical trial aims to evaluate the efficacy of the Er:YAG laser in the removal of impacted mandibular third molars compared to the conventional surgical technique. The study assesses surgical efficiency, postoperative pain, swelling, trismus, and overall patient recovery. The goal is to determine whether the Er:YAG laser provides a safer and less traumatic alternative to traditional bone-cutting methods during third molar surgery.
Read the detailed description
Impacted mandibular third molars are among the most commonly extracted teeth, and conventional surgical removal often involves bone cutting using rotary instruments, which may increase postoperative morbidity. Laser-assisted surgery, particularly using the Er:YAG laser, has been proposed as a minimally invasive alternative with potential benefits such as reduced thermal damage, improved healing, and less postoperative discomfort.
This study compares Er:YAG laser-assisted bone removal with the conventional bur technique in terms of operative time, intraoperative ease, and postoperative outcomes including pain, edema, and trismus. Patients meeting the eligibility criteria are randomly allocated into two groups: a laser-assisted surgery group and a conventional surgery group. Standardized measurements and follow-up assessments are conducted to evaluate clinical outcomes and determine the effectiveness and safety of the Er:YAG laser in third molar surgery.
- Conditions
- Impacted Mandibular Third Molar
- Being tested
- Er:YAG laser, Conventional Rotary Instruments Surgery
- Keywords
- Third Molar Surgery, Er:YAG Laser, Laser-Assisted Surgery, Oral Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG laserDevice
Er:YAG laser (2940 nm) used for bone cutting during impacted mandibular third molar surgery.
Conventional Rotary Instruments SurgeryProcedure or surgery
Conventional rotary instruments used for bone removal during surgical extraction of impacted mandibular third molars.
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG Laser Group | Experimental | Participants in this group will undergo impacted mandibular third molar surgery using the Er:YAG laser for bone removal. Receives: Device: Er:YAG laser |
| Conventional Rotary Instrument Group | Active comparator | Participants in this group will undergo impacted mandibular third molar surgery using conventional rotary instruments (bur and handpiece) for bone cutting. Receives: Procedure: Conventional Rotary Instruments Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain) at postoperative intervals.
Measured: Immediate postoperative, 24 hours, 3 days, and 7 days
Secondary outcomes (3)
Postoperative Swelling
Facial swelling will be measured using linear facial measurements (tragus-pogonion and gonion-pogonion distances) preoperatively and at postoperative intervals.
Measured: Immediate postoperative, 24 hours, 3 days, and 7 days
Postoperative Trismus
Maximum interincisal mouth opening will be measured in millimeters preoperatively and at postoperative intervals to assess trismus.
Measured: Immediate postoperative, 24 hours, 3 days, and 7 days
Bone Density
Bone density at the extraction site will be assessed using standardized digital radiographs. Gray-scale values will be measured at predetermined reference points to compare bone healing between groups.
Measured: Immediate postoperative, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start25 Sep 2024
- Primary completion15 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Mandibular Third MolarStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants are randomly assigned into two parallel groups: Er:YAG laser-assisted surgery and conventional rotary instrument surgery.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Anwer Ahmed Nazmy, Alexandria University
- Investigators
- Karim Elhaw, MSc (Oral Laser Applications), Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297043
- Sponsor's protocol ID
- ALEXDEN-KA-IMP_M3-2025
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been determined. Decisions regarding IPD sharing will depend on institutional policies, ethical approvals, and future publication requirements.
Publications
Elhaw KA, Abdelhakim AA, Dominguez J A, Eldibany RM, Tost A E. Efficacy of Er:YAG laser in removal of impacted mandibular third molars (a randomized controlled clinical trial). BMC Oral Health. 2026 Jun 5;26(1):1060. doi: 10.1186/s12903-026-08790-w.
PubMed 42243813
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Er:YAG Laser in Removal of Impacted Mandibular Third Molars (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07297043
- Acronym / sponsor ID
- ALEXDEN-KA-IMP_M3-2025
- Conditions
- Impacted Mandibular Third Molar
- Keywords
- Third Molar Surgery, Er:YAG Laser, Laser-Assisted Surgery, Oral Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 22 Dec 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.
This randomized controlled clinical trial aims to evaluate the efficacy of the Er:YAG laser in the removal of impacted mandibular third molars compared to the conventional surgical technique. The study assesses surgical efficiency, postoperative pain, swelling, trismus, and overall patient recovery. The goal is to determine whether the Er:YAG laser provides a safer and less traumatic alternative to traditional bone-cutting methods during third molar surgery.
Detailed description
Impacted mandibular third molars are among the most commonly extracted teeth, and conventional surgical removal often involves bone cutting using rotary instruments, which may increase postoperative morbidity. Laser-assisted surgery, particularly using the Er:YAG laser, has been proposed as a minimally invasive alternative with potential benefits such as reduced thermal damage, improved healing, and less postoperative discomfort.
This study compares Er:YAG laser-assisted bone removal with the conventional bur technique in terms of operative time, intraoperative ease, and postoperative outcomes including pain, edema, and trismus. Patients meeting the eligibility criteria are randomly allocated into two groups: a laser-assisted surgery group and a conventional surgery group. Standardized measurements and follow-up assessments are conducted to evaluate clinical outcomes and determine the effectiveness and safety of the Er:YAG laser in third molar surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned into two parallel groups: Er:YAG laser-assisted surgery and conventional rotary instrument surgery.
| Arm | Type | Receives |
|---|---|---|
| Er:YAG Laser Group | Experimental | Device: Er:YAG laserParticipants in this group will undergo impacted mandibular third molar surgery using the Er:YAG laser for bone removal. |
| Conventional Rotary Instrument Group | Active comparator | Procedure: Conventional Rotary Instruments SurgeryParticipants in this group will undergo impacted mandibular third molar surgery using conventional rotary instruments (bur and handpiece) for bone cutting. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Adults aged 20-30 years requiring surgical extraction of a mesioangular impacted mandibular third molar.
Key exclusion criteria (7 listed)
- • Systemic medical conditions affecting bone healing or postoperative response (e.g., uncontrolled diabetes, immunodeficiency, metabolic bone disorders).
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 |
|---|---|---|
| Er:YAG laserEr:YAG laser (2940 nm) used for bone cutting during impacted mandibular third molar surgery. | Device | Er:YAG Laser Group |
| Conventional Rotary Instruments SurgeryConventional rotary instruments used for bone removal during surgical extraction of impacted mandibular third molars. | Procedure or surgery | Conventional Rotary Instrument Group |
Primary outcome
Postoperative Pain Score
Time frame: Immediate postoperative, 24 hours, 3 days, and 7 days
Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain) at postoperative intervals.
3 secondary outcomes
Postoperative Swelling
Time frame: Immediate postoperative, 24 hours, 3 days, and 7 days
Postoperative Trismus
Time frame: Immediate postoperative, 24 hours, 3 days, and 7 days
Bone Density
Time frame: Immediate postoperative, 1 month, and 3 months
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 29 Dec 2025.
- Derived from this study: PubMed 42243813Elhaw KA, Abdelhakim AA, Dominguez J A, Eldibany RM, Tost A E. Efficacy of Er:YAG laser in removal of impacted mandibular third molars (a randomized controlled clinical trial). BMC Oral Health. 2026 Jun 5;26(1):1060. doi: 10.1186/s12903-026-08790-w.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been determined. Decisions regarding IPD sharing will depend on institutional policies, ethical approvals, and future publication requirements.
Related trials for Impacted Mandibular Third Molar
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
Active, not recruiting
Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
Facial Swelling, Tooth Position Anomalies
Recruiting
Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
Alveolar Bone Loss
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.
Karim Elhaw, MSc (Oral Laser Applications) principal investigator
Alexandria 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 Er:YAG laser and Conventional Rotary Instruments Surgery in people with Impacted Mandibular Third Molar, run by Alexandria University at 1 site in Egypt.
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 6 inclusion and 7 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 29 Dec 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 Egypt. 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?
Postoperative Pain Score (time frame: Immediate postoperative, 24 hours, 3 days, and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07297043, which also lists 1 linked publication.
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 29 Dec 2025.