Effect of Low Level Diode Laser Biostimulation on Implant Stability

NCT07044245 | Completed

• 1 other identifier: LLLT-premolars
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immediate Implant Placement; Laser; Biostimulation

Keywords

immediate implant; ISQ; LLLT; clinical stability

Outcome Measures

Primary Outcomes (1)

• Implant Stability Assessment using Radio frequency analysis

  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 Outcomes (1)

• Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.

  4 months

Study Arms (2)

Patients with immediate implant placement in maxillary premolars receiving low laser Biostimulation

ACTIVE COMPARATOR

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

Patients with immediate implant placement in maxillary premolars receiving sham laser

SHAM COMPARATOR

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

Interventions

immediate maxillary premolar implant placement with no subsequent laser Biostimulation PROCEDURE

Sham laser application

Patients with immediate implant placement in maxillary premolars receiving sham laser

immediate maxillary premolar implant placement with subsequent laser Biostimulation PROCEDURE

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

Patients with immediate implant placement in maxillary premolars receiving low laser Biostimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location

Study Officials

• yehia El-Mahallawy, Phd

  Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator Furthermore, outcome assessor was blinded from the group enrollment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with immediate implant placement in the of maxillary premolars with low laser Biostimulation

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 29, 2025
• Study Start: November 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: March 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Access Criteria: to any one who required them after deidentification

Locations

EG (1)