Effect of Low Level Diode Laser Biostimulation on Implant Stability

June 27, 2025 updated by: Alexandria University

Evaluation of the Effect of Low Level Diode Laser Biostimulation on Implant Stability in Immediate Implant in The Maxillary Premolars. A Randomized Clinical Trial.

Tooth loss is accompanied by bone loss in all dimensions, so preservation of the bone is mandatory for placement of dental implant, as bone quantity and quality are predictive factors in achieving proper primary stability. Low level bio stimulation has stimulatory effect on bone cells so it can be used in immediate implants to increase bone formation around the implant.

the Aim of this study is to evaluate the effect of low-level diode laser Biostimulation on immediate implants in maxillary premolars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

20 patients with unrestorable maxillary premolars were included in the study treated with immediate implants. Patients were divided into two groups (n=10). Group 1 Received immediate implant with low level diode laser application (study), and group 2 received immediate implant without laser application (control). Preoperative clinical and radiographic evaluation, immediate post operative and after 4 months radiographic evaluation to assess stability and bone density around the implant.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21523
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with unrestorable maxillary premolars with sufficient bone quantity to receive the dental implant.
  2. Age ranging from 25-45.
  3. Patients with no local or systemic pathology that can interfere with normal wound healing.
  4. Non- smokers.
  5. Patients that are properly motivated to complete follow up visits.
  6. Patients with adequate oral hygiene or willing to improve their oral hygiene to ensure uncompromised wound healing.

Exclusion Criteria:

  1. Patients with uncontrolled medical condition that can affect surgical outcome or bone and wound healing. (ex: diabetes mellitus)
  2. Patients with periapical pathology that may contraindicate immediate implant placement.
  3. History of receiving irradiation in head and neck region

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with immediate implant placement in maxillary premolars receiving low laser Biostimulation
Patients with immediate implant placement in maxillary premolars receiving low laser Biostimulation after placement on two sessions
Procedure: immediate maxillary premolar implant placement with subsequent laser Biostimulation
low lever biostimulation was performed on two consecutive sessions each of 100 s. First session was carried out immediately on surgery time after implant placement, using a diode laser Photo-biomodulation tip in a continuous wave and non-contact mode
Sham Comparator: Patients with immediate implant placement in maxillary premolars receiving sham laser
Patients with immediate implant placement in maxillary premolars receiving sham laser as a control
Procedure: immediate maxillary premolar implant placement with no subsequent laser Biostimulation
Sham laser application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability Assessment using Radio frequency analysis
Time Frame: 4 month
Secondary implant stability analysis was performed 4-months after implant placement. Radio frequency analysis (RFA) was performed using Osstell device (Integration diagnostic Ltd. Company, Sävedalen, Sweden). Primary and secondary implant stability were analyzed and compared. The use of the Osstell and ISQ values were obtained by a blinded operator
4 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.
Time Frame: 4 months
A postoperative CBCT will be taken within 24 hours of implant placement followed by a 6-months scan, and values will be compared with the preoperative record. The assessment will be conducted using the tools on the "On Demand 3D App." Software*. The following criteria will be assessed:
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: yehia El-Mahallawy, Phd, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

June 19, 2025

First Submitted That Met QC Criteria

June 27, 2025

First Posted (Actual)

June 29, 2025

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LLLT-premolars

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study

IPD Sharing Access Criteria

to any one who required them after deidentification

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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