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临床试验/NCT07636265
NCT07636265已完成1 期

The Effect of Photobiomodulation on Inflammation Levels and Stability Following Dental Implantation: A Randomised, Single-Blind, Controlled Study

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
50
试验地点
1

研究概览

简要总结

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.

详细描述

No reference to a name or number is given in the 'brief summary'.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • 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

排除标准

  • • 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

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nida GEÇGİL

associate professor

Nigde Omer Halisdemir University

研究点 (1)

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