Immediate Implant PlacementNCT07044245
Effect of Low Level Diode Laser Biostimulation on Implant Stability
A study testing immediate maxillary premolar implant placement with no subsequent laser Biostimulation and immediate maxillary premolar implant placement with subsequent laser Biostimulation in people with Immediate Implant Placement and Laser, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immediate Implant Placement, Laser, Biostimulation
- What is being tested?
- immediate maxillary premolar implant placement with no subsequent laser Biostimulation and immediate maxillary premolar implant placement with subsequent laser Biostimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
About this study
Official title: 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.
Read the 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.
- Conditions
- Immediate Implant Placement, Laser, Biostimulation
- Being tested
- immediate maxillary premolar implant placement with no subsequent laser Biostimulation, immediate maxillary premolar implant placement with subsequent laser Biostimulation
- Keywords
- immediate implant, ISQ, LLLT, clinical stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate maxillary premolar implant placement with no subsequent laser BiostimulationProcedure or surgery
Sham laser application
immediate maxillary premolar implant placement with subsequent laser BiostimulationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: immediate maxillary premolar implant placement with no subsequent laser Biostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 month
Secondary outcomes (1)
Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.
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:
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Nov 2023
- Primary completion1 Aug 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant PlacementStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with immediate implant placement in the of maxillary premolars with low laser Biostimulation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yehia El-Mahallawy, Phd, Principal investigator, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044245
- Sponsor's protocol ID
- LLLT-premolars
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Low Level Diode Laser Biostimulation on Implant Stability in Immediate Implant in The Maxillary Premolars. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07044245
- Acronym / sponsor ID
- LLLT-premolars
- Conditions
- Immediate Implant Placement, Laser, Biostimulation
- Keywords
- immediate implant, ISQ, LLLT, clinical stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with immediate implant placement in the of maxillary premolars with low laser Biostimulation
| Arm | Type | Receives |
|---|---|---|
| Patients with immediate implant placement in maxillary premolars receiving low laser Biostimulation | Active comparator | Procedure: immediate maxillary premolar implant placement with subsequent laser BiostimulationPatients with immediate implant placement in maxillary premolars receiving low laser Biostimulation after placement on two sessions |
| Patients with immediate implant placement in maxillary premolars receiving sham laser | Sham comparator | Procedure: immediate maxillary premolar implant placement with no subsequent laser BiostimulationPatients with immediate implant placement in maxillary premolars receiving sham laser as a control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immediate maxillary premolar implant placement with no subsequent laser BiostimulationSham laser application | Procedure or surgery | Patients with immediate implant placement in maxillary premolars receiving sham laser |
| immediate maxillary premolar implant placement with subsequent laser Biostimulationlow 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 | Procedure or surgery | Patients with immediate implant placement in maxillary premolars receiving low laser Biostimulation |
Primary outcome
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
1 secondary outcome
Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Yes. 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
Related trials for Immediate Implant Placement
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Active, not recruiting
Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments
Implant
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yehia El-Mahallawy, Phd principal investigator
Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate maxillary premolar implant placement with no subsequent laser Biostimulation and immediate maxillary premolar implant placement with subsequent laser Biostimulation in people with Immediate Implant Placement and Laser, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability Assessment using Radio frequency analysis (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.