How low-level laser therapy helps dental implants stay stable in different bone types
| ISRCTN | ISRCTN12123964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12123964 |
| Secondary identifying numbers | Research ID (702), College of Dentistry/ University of Sulaimani |
- Submission date
- 17/03/2025
- Registration date
- 19/03/2025
- Last edited
- 17/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The purpose of this study is to evaluate the effectiveness of laser biomodulation in enhancing the osseointegration and stability of dental implants. This research aims to improve the outcomes of dental implant procedures, potentially offering better long term success rates for patients and shortening the loading time.
Who can participate?
Patients aged 18-60 years old who are medically fit with sufficient bone volume and require bilateral maxillary dental implants.
What does the study involve?
Participants in this study will undergo the standard dental implant procedure with the application of laser every 2 weeks for 2 months. The procedure will be performed by a qualified dental professional, and follow-up visits will be scheduled to monitor the osseointegration and stability of the implant. During these visits, they may undergo radiographic
imaging and other assessments as required.
What are the possible benefits and risks of participating?
Participants may benefit from improved implant outcomes. However, these benefits are not guaranteed. The risks involved in this study are similar to those associated with standard dental implant procedures, including but not limited to infection, implant failure, and discomfort. In addition, the use of laser is expected to enhance implant stability and osseointegration, potentially reducing the risk of implant failure.
Where is the study run from?
The study will be conducted at the postgraduate clinics of the College of Dentistry, University of Sulaimani.
When is the study starting and how long is it expected to run for?
December 2024 to November 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Omer Ali Hama, Omer.hama@univsul.edu.iq
Contact information
Public, Scientific, Principal Investigator
Madame Mitterrand
As Sulaymaniyah
46001
Iraq
 ORCID ID |
0000-0001-5023-1550 |
|---|---|
| Phone | +9647703601168 |
| omer.hama@univsul.edu.iq |
Study information
| Study design | Split-mouth randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic, University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | 47017_PIS Informed Consent Form.pdf |
| Scientific title | Effect of low-level laser therapy on stability of dental implants in D3 and D4 bone quality: a split-mouth randomized controlled clinical trial |
| Study objectives | Regarding secondary implant stability after 2 months, there is no significant difference between using laser therapy on the implant area and following standard procedures for dental implants in D3 and D4 bone quality in the upper jaw. |
| Ethics approval(s) |
Approved 16/12/2024, The Ethics Committee of the College of Dentistry (University of Sulaimani, As Sulaymaniyah, 46001, Iraq; +964 770 452 2890; dentistry.ethics@univsul.edu.iq), ref: COD-EC-24 -0057 |
| Health condition(s) or problem(s) studied | Effect of low-level laser therapy on stability of dental implants in D3 and D4 bone quality |
| Intervention | Sample and sample size Forty implants in patients aged 18-60 years old, requesting dental implants with bilateral D3 and D4 maxillary bone after taking informed consent for participation in this study will be included in this study. Then patients will be randomly recruited and the maxillary arches will be randomly assigned to two groups (20 implants for each group). For the randomization when a patient is recruited before any radiographic or clinical assessment randomly we assign one side of the Jaw to be study group and the other side as the control. This commenced with the upper right side being the control in the first case, the left side being the control in the next case and so on. First group: Standard implant site preparation. (Control group one side of the maxilla for each test group). Second group: Standard implant site preparation and Laser photobiomodulation. Exclusion Criteria: Patients with systemic disease that affects bone metabolism and healing, smokers and bone height less than 10 mm will be excluded. - Cone-beam computed tomography (CBCT) radiological assessment is going to be done for each patient to determine the volume of bone and density using the Hounsfield unit (HU). - Surgical guide and flapless approach will be used for placement of the implants and for the precise localization of the implant for the next visits. - PSK line two piece Oxy dental implants, diameter of 4.0 mm and 4.5 mm and length of 10.0 mm and 11.5 mm will be placed in at least 10 patients. - Delayed implant placement and delayed loading protocols will be employed in this study. - Low Level Diode laser will be used for laser group and the first session will be applied on the first day of implant placement and will continue over 2 months at intervals of every 2 weeks. - Lasing Parameters: Wavelength (940nm) at a 2mm distance, continuous wave with 0.3 W output power at four different locations (Buccal, Palatal, Mesial and Distal) for 20 seconds each at minimum 10 J/cm2. - Resonance Frequency Analysis (RFA) using Osstell® device will be used to record the ISQ at time of implant placement and after 2 months. The Osstell ISQ Scale will be used to define the stability of the implant. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Implant stability quotient (ISQ) value measured using Resonance Frequency Analysis with an Osstell® device at time of implant placement and after 2 months |
| Secondary outcome measures | Marginal bone loss measured using cone-beam computed tomography (CBCT) radiological assessment in the initial healing period |
| Overall study start date | 01/12/2024 |
| Completion date | 01/11/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | Medically fit patients requesting bilateral dental implants with D3 and D4 maxillary bone |
| Key exclusion criteria | 1. Patients with systemic diseases and/or on medications that affect bone metabolism and healing 2. Smokers 3. Bone height less than 10 mm |
| Date of first enrolment | 01/12/2024 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- Iraq
Study participating centre
As sulaymaniyah
46001
Iraq
Sponsor information
University/education
City campus, Eskan, Zanko Street, Sulaimania
Sulaymaniyah
46001
Iraq
| Phone | +9647725447528 |
|---|---|
| pg.dent@univsul.edu.iq | |
| Website | https://univsul.edu.iq |
"ROR" |
https://ror.org/00saanr69 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/03/2025 | No | Yes |
Additional files
Editorial Notes
17/06/2025: The overall study end date was changed from 01/08/2025 to 01/11/2025.
03/06/2025: The recruitment end date was changed from 01/06/2025 to 01/09/2025.
17/03/2025: Study's existence confirmed by the Ethics Committee of the College of Dentistry, University of Sulaimani. Note that informal ethical approval was given to start recruitment before formal approval because of a governmental delay.
