Effect of Low Level Diode Laser Biostimulation on Implant Stability

NCT ID: NCT07044245

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Immediate Implant Placement Laser Biostimulation

Keywords

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immediate implant ISQ LLLT clinical stability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with immediate implant placement in the of maxillary premolars with low laser Biostimulation
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

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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

Group Type ACTIVE_COMPARATOR

immediate maxillary premolar implant placement with subsequent laser Biostimulation

Intervention Type 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 sham laser

Patients with immediate implant placement in maxillary premolars receiving sham laser as a control

Group Type SHAM_COMPARATOR

immediate maxillary premolar implant placement with no subsequent laser Biostimulation

Intervention Type PROCEDURE

Sham laser application

Interventions

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immediate maxillary premolar implant placement with no subsequent laser Biostimulation

Sham laser application

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yehia El-Mahallawy, Phd

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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LLLT-premolars

Identifier Type: -

Identifier Source: org_study_id