NCT07297043

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 9, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

Third Molar SurgeryEr:YAG LaserLaser-Assisted SurgeryOral Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Postoperative Swelling

    Immediate postoperative, 24 hours, 3 days, and 7 days

  • Postoperative Trismus

    Immediate postoperative, 24 hours, 3 days, and 7 days

  • Bone Density

    Immediate postoperative, 1 month, and 3 months

Study Arms (2)

Er:YAG Laser Group

EXPERIMENTAL

Participants in this group will undergo impacted mandibular third molar surgery using the Er:YAG laser for bone removal.

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.

Procedure: Conventional Rotary Instruments Surgery

Interventions

Er:YAG laser (2940 nm) used for bone cutting during impacted mandibular third molar surgery.

Er:YAG Laser Group

Conventional rotary instruments used for bone removal during surgical extraction of impacted mandibular third molars.

Conventional Rotary Instrument Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Karim Elhaw, MSc (Oral Laser Applications)

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was performed because both the surgeon and the participants were aware of the intervention type.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned into two parallel groups: Er:YAG laser-assisted surgery and conventional rotary instrument surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Researcher, Oral Laser Applications

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

September 25, 2024

Primary Completion

January 15, 2025

Study Completion

January 29, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations