The Effect Of Photobiomodulation On Dental Implant Survival

NCT07636265 | Completed Phase 1 DMC

• 1 other identifier: NigdeOHUDentistry
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Implant Complication; Periimplant Infection; Periimplant Bone Loss

Keywords

dental implants, RFA,; low level laser therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  12 weeks

Study Arms (2)

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

Device: photobiomodulation

Interventions

photobiomodulation DEVICE

Photobiomodulation will be applied to the implant located on one side of the mouth in 50 participants

intervention group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Niğde Province, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• NİDA GEÇKİL, assoc.prof.

  Nigde Omer Halisdemir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: June 9, 2026
• Study Start: October 15, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)