Implant ComplicationPhase 1NCT07636265
The Effect Of Photobiomodulation On Dental Implant Survival
A Phase 1 study testing photobiomodulation in people with Implant Complication and Periimplant Infection, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Dental implants offer a high success rate as the most up-to-date treatment method for replacing lost teeth. However, whilst implants have emerged as the ideal treatment for tooth loss, the incidence of postoperative complications-including postoperative oedema, wound infection, and early dehiscence or perforation of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Complication, Periimplant Infection, Periimplant Bone Loss
- What is being tested?
- photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 15 Apr 2026
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Male and female patients aged between 18 and 55
- Patients who are mentally and physically healthy
- Patients with missing teeth of the same number on both sides of the maxilla or mandible, and who are suitable candidates for dental implants
- Patients who volunteer for the study, sign the consent form and attend follow-up appointments
- Patients who smoke five or fewer cigarettes per day
Who cannot join
- • Patients who smoke
- Patients taking medication that affects bone quality or who have a systemic disease
- Patients with psychiatric disorders
- Pregnant or breastfeeding women
- Patients with parafunctional habits such as bruxism
- Patients with suspected cysts or tumours in the implant site, or those requiring grafting
- Unilateral implant cases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nigde Omer Halisdemir University
Niğde, Niğde Province
About this study
Official title: The Effect of Photobiomodulation on Inflammation Levels and Stability Following Dental Implantation: A Randomised, Single-Blind, Controlled Study
Dental implants offer a high success rate as the most up-to-date treatment method for replacing lost teeth. However, whilst implants have emerged as the ideal treatment for tooth loss, the incidence of postoperative complications-including postoperative oedema, wound infection, and early dehiscence or perforation of the soft tissue flap-has also increased. The soft tissue surrounding the implant forms a strong barrier to prevent bacteria and metabolic by-products from entering deeper tissues and colonising the implant surface. Complications related to soft tissue can negatively affect implant success by leading to bacterial invasion in the early stages. Therefore, the rapid establishment of effective soft tissue sealing is crucial for establishing and maintaining the health of peri-implant tissues. Consequently, the search for a method capable of supporting the healing of soft tissues around the implant is a significant area of research in modern dental implantology. The primary stability of dental implants is defined by the biomechanical stability achieved during implant placement. The quantity and quality of the residual bone are key determinants of primary stability. The process continues with secondary stability, during which osseointegration is expected. As osseointegration requires complete structural and functional bonding between the living tissue and the implant surface, it is influenced by numerous factors. Low-level laser therapy or photobiomodulation (PBM) has been proposed as a method that may support osseointegration by reducing healing time in preclinical and clinical studies.
PBM involves the use of light across a broad wavelength range from red to infrared to produce analgesic, anti-inflammatory and biological stimulation effects. Different wavelengths are selected depending on the desired effect. The 660 nm wavelength (red light) increases adenozin tri phosphate (ATP) production, which provides energy for cellular repair and regeneration, and alters mitochondrial membrane potential. It also aids tissue healing by promoting collagen synthesis. The 808 nm wavelength (near-infrared light) penetrates deeper into tissues, reducing inflammatory responses by regulating reactive oxygen species and cytokine levels. There is no specific guideline regarding which wavelength of PBM should be applied for osseointegration and soft tissue healing. In this study, drawing on similar studies, two different wavelengths were examined to demonstrate the described effects. Resonance frequency analysis (RFA) is recognised as a commonly used and reliable method for measuring the stability of dental implants. RFA analysis is performed using specialised devices containing a 'smart pin' placed in the implant or abutment to quantify stability numerically. The implant stability quotient (ISQ) is presented using a numerical scale ranging from 0 to 100, and a higher ISQ value indicates better overall stability.
Read more
Following dental implant surgery, patients exhibit varying degrees of inflammatory signs. Among these signs, pain typically peaks 24 to 72 hours after surgery and then gradually subsides in a physiological manner. Pain is a significant parameter affecting the patient's quality of life and is a finding that must be considered when monitoring the process. For this reason, our study includes measurements of the Healing Index (HI), Modified Sulcus Bleeding Index (mSBI), and Gingival Index (GI), as well as Visual Analogue Scale (VAS) scores.
The aim of this clinical, prospective, comparative study is to evaluate the effect of 808 nm diode laser PBM on implant stability using RFA measurements, and the effect of 660 nm diode laser PBM on inflammation, pain, and postoperative healing.
Read the detailed description
No reference to a name or number is given in the 'brief summary'.
- Being tested
- photobiomodulation
- Keywords
- dental implants, RFA,, low level laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationDevice
Photobiomodulation will be applied to the implant located on one side of the mouth in 50 participants
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | In 50 participants, non-irradiating light of the same colour as the implant will be applied to one side of the mouth using photobiomodulation |
| intervention group | Experimental | In 50 participants, photobiomodulation will be applied to the other side of the mouth Receives: Device: photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
One of the primary outcomes of this study is to investigate the effects of low-level laser therapy on the periodontal healing of dental implants using clinical scales.
The effect of low-level laser therapy on periodontal healing following dental implant placement will be assessed 7 days after the procedure using the Healing Index (HI). This index indicates a final HI score ranging from 0 for poor healing to 5 for excellent healing. In addition, the modified sulcus bleeding index (mSBI) will be used on the same day (7 days after the procedure) to assess bleeding. Scores from 4 surfaces will be recorded to calculate the average score. The scoring criteria will be as follows: 0 = no bleeding at the gingival margin; 1 = isolated punctate bleeding; 2 = linear swelling in the gingival sulcus; 3 = severe or spontaneous bleeding. As both scores indicate periodontal healing, these scores have been combined into a single outcome measure.
Measured: 2 weeks
The effect of low-level laser therapy on the level of inflammation following dental implant placement
The effect of low-level laser therapy on the level of inflammation following dental implant surgery will be assessed 7 days after the procedure using the Visual Analogue Scale (VAS). On this scale, patients will be asked to rate their pain numerically on a scale of 1 (no pain) to 10 (severe pain).
Measured: 2 weeks
An investigation into the effect of low-level laser therapy on the stability of dental implants using resonance frequency analysis.
The effect of low-level laser therapy on the stability of dental implants will be measured using resonance frequency analysis. This measurement will be taken immediately after surgery and at the 3-month follow-up. The measuring device measures metal vibration via a conductive interface and provides a numerical value between 0 and 90. Numerical values of 70 or above will indicate sufficient stability.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start15 Oct 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nida GEÇGİL, Nigde Omer Halisdemir University
- Investigators
- NİDA GEÇKİL, assoc.prof., Study director, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636265
- Sponsor's protocol ID
- NigdeOHUDentistry
- Status last verified
- Jun 2026
- First submitted
- 16 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Photobiomodulation on Inflammation Levels and Stability Following Dental Implantation: A Randomised, Single-Blind, Controlled Study
- ClinicalTrials.gov ID
- NCT07636265
- Acronym / sponsor ID
- NigdeOHUDentistry
- Keywords
- dental implants, RFA,, low level laser therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 9 Jun 2026 (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.
Dental implants offer a high success rate as the most up-to-date treatment method for replacing lost teeth. However, whilst implants have emerged as the ideal treatment for tooth loss, the incidence of postoperative complications-including postoperative oedema, wound infection, and early dehiscence or perforation of the soft tissue flap-has also increased. The soft tissue surrounding the implant forms a strong barrier to prevent bacteria and metabolic by-products from entering deeper tissues and colonising the implant surface. Complications related to soft tissue can negatively affect implant success by leading to bacterial invasion in the early stages. Therefore, the rapid establishment of effective soft tissue sealing is crucial for establishing and maintaining the health of peri-implant tissues. Consequently, the search for a method capable of supporting the healing of soft tissues around the implant is a significant area of research in modern dental implantology. The primary stability of dental implants is defined by the biomechanical stability achieved during implant placement. The quantity and quality of the residual bone are key determinants of primary stability. The process continues with secondary stability, during which osseointegration is expected. As osseointegration requires complete structural and functional bonding between the living tissue and the implant surface, it is influenced by numerous factors. Low-level laser therapy or photobiomodulation (PBM) has been proposed as a method that may support osseointegration by reducing healing time in preclinical and clinical studies.
PBM involves the use of light across a broad wavelength range from red to infrared to produce analgesic, anti-inflammatory and biological stimulation effects. Different wavelengths are selected depending on the desired effect. The 660 nm wavelength (red light) increases adenozin tri phosphate (ATP) production, which provides energy for cellular repair and regeneration, and alters mitochondrial membrane potential. It also aids tissue healing by promoting collagen synthesis. The 808 nm wavelength (near-infrared light) penetrates deeper into tissues, reducing inflammatory responses by regulating reactive oxygen species and cytokine levels. There is no specific guideline regarding which wavelength of PBM should be applied for osseointegration and soft tissue healing. In this study, drawing on similar studies, two different wavelengths were examined to demonstrate the described effects. Resonance frequency analysis (RFA) is recognised as a commonly used and reliable method for measuring the stability of dental implants. RFA analysis is performed using specialised devices containing a 'smart pin' placed in the implant or abutment to quantify stability numerically. The implant stability quotient (ISQ) is presented using a numerical scale ranging from 0 to 100, and a higher ISQ value indicates better overall stability.
Following dental implant surgery, patients exhibit varying degrees of inflammatory signs. Among these signs, pain typically peaks 24 to 72 hours after surgery and then gradually subsides in a physiological manner. Pain is a significant parameter affecting the patient's quality of life and is a finding that must be considered when monitoring the process. For this reason, our study includes measurements of the Healing Index (HI), Modified Sulcus Bleeding Index (mSBI), and Gingival Index (GI), as well as Visual Analogue Scale (VAS) scores.
The aim of this clinical, prospective, comparative study is to evaluate the effect of 808 nm diode laser PBM on implant stability using RFA measurements, and the effect of 660 nm diode laser PBM on inflammation, pain, and postoperative healing.
Detailed description
No reference to a name or number is given in the 'brief summary'.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –In 50 participants, non-irradiating light of the same colour as the implant will be applied to one side of the mouth using photobiomodulation |
| intervention group | Experimental | Device: photobiomodulationIn 50 participants, photobiomodulation will be applied to the other side of the mouth |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Male and female patients aged between 18 and 55
Key exclusion criteria (7 listed)
- • Patients who smoke
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 |
|---|---|---|
| photobiomodulationPhotobiomodulation will be applied to the implant located on one side of the mouth in 50 participants | Device | intervention group |
Primary outcome
One of the primary outcomes of this study is to investigate the effects of low-level laser therapy on the periodontal healing of dental implants using clinical scales.
Time frame: 2 weeks
The effect of low-level laser therapy on periodontal healing following dental implant placement will be assessed 7 days after the procedure using the Healing Index (HI). This index indicates a final HI score ranging from 0 for poor healing to 5 for excellent healing. In addition, the modified sulcus bleeding index (mSBI) will be used on the same day (7 days after the procedure) to assess bleeding. Scores from 4 surfaces will be recorded to calculate the average score. The scoring criteria will be as follows: 0 = no bleeding at the gingival margin; 1 = isolated punctate bleeding; 2 = linear swelling in the gingival sulcus; 3 = severe or spontaneous bleeding. As both scores indicate periodontal healing, these scores have been combined into a single outcome measure.
The effect of low-level laser therapy on the level of inflammation following dental implant placement
Time frame: 2 weeks
The effect of low-level laser therapy on the level of inflammation following dental implant surgery will be assessed 7 days after the procedure using the Visual Analogue Scale (VAS). On this scale, patients will be asked to rate their pain numerically on a scale of 1 (no pain) to 10 (severe pain).
An investigation into the effect of low-level laser therapy on the stability of dental implants using resonance frequency analysis.
Time frame: 12 weeks
The effect of low-level laser therapy on the stability of dental implants will be measured using resonance frequency analysis. This measurement will be taken immediately after surgery and at the 3-month follow-up. The measuring device measures metal vibration via a conductive interface and provides a numerical value between 0 and 90. Numerical values of 70 or above will indicate sufficient stability.
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 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
NİDA GEÇKİL, assoc.prof. study director
Nigde Omer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing photobiomodulation in people with Implant Complication and Periimplant Infection, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 9 Jun 2026. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
One of the primary outcomes of this study is to investigate the effects of low-level laser therapy on the periodontal healing of dental implants using clinical scales. (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 9 Jun 2026.