Efficacy of Er:YAG Laser in Removing Impacted Mandibular Third Molars (ERYAG-M3)

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.

Study Overview

• Status: Completed
• Conditions: Impacted Mandibular Third Molar
• Intervention / Treatment: Device: Er:YAG laser; Procedure: Conventional Rotary Instruments 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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt
      • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Er:YAG Laser Group; Participants in this group will undergo impacted mandibular third molar surgery using the Er:YAG laser for bone removal.	Device: Er:YAG laser; Er:YAG laser (2940 nm) used for bone cutting during impacted mandibular third molar surgery.
Active Comparator: Conventional Rotary Instrument Group; Participants in this group will undergo impacted mandibular third molar surgery using conventional rotary instruments (bur and handpiece) for bone cutting.	Procedure: Conventional Rotary Instruments Surgery; Conventional rotary instruments used for bone removal during surgical extraction of impacted mandibular third molars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediate postoperative, 24 hours, 3 days, and 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Swelling	Facial swelling will be measured using linear facial measurements (tragus-pogonion and gonion-pogonion distances) preoperatively and at postoperative intervals.	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.	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.	Immediate postoperative, 1 month, and 3 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Karim Elhaw, MSc (Oral Laser Applications), Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 29, 2025

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Estimated): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Oral Surgery; Er:YAG Laser; Third Molar Surgery; Laser-Assisted Surgery
• Additional Relevant MeSH Terms: Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Lasers, Solid-State
• Other Study ID Numbers: ALEXDEN-KA-IMP_M3-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No