Rosebengal Assisted Antimicrobial Photodynamic Therapy as an Adjunct To Mechanical Debridement In Non Surgical Management Of Periimplantitis- A Randomised Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Pocket Probing Depth (PPD).
研究概览
简要总结
Peri-implantitis refers to a localized infection that triggers inflammation in soft tissues and leads to bone deterioration around a surgically integrated implant in use. The causes of this implant-related infection are influenced by factors such as the condition of the tissue surrounding the implant, the design of the implant itself, its surface roughness, external shape, and excessive mechanical stress. The primary cause behind implant failure are typically spiral-shaped bacteria and mobile variants of Gram-negative anaerobic bacteria, unless the issue stems solely from mechanical strain. Over the years, lasers have been utilized in the field of periodontology to disinfect the periodontal pockets since they possess exceptionally good bactericidal capabilities. By causing heat denaturation, direct ablation, or destruction of bacterial cells, the lasers possess a bactericidal effect. An unintentional discovery made in the early 20th century, antimicrobial photodynamic therapy (a-PDT) is used in medicine to inactivate cells using light. The three main components of antimicrobial photodynamic treatment are oxygen, nontoxic photosensitizers, and a source of visible light. The principle behind its use is when a suitable light of a specific wavelength when irradiated can activate the photosensitizes by producing high reactive state of oxygen called as singlet oxygen which reacts with the surrounding cells. The reactive oxygen species damage the cell wall of the microorganisms. This happens in a limited space leading to localized response. There are various photosensitizing agents like toluidine blue, methylene blue, erythrosine, hematoporphyrin, chlorine and xanthene dyes. Rose bengal (RB) dye, a xanthene derivate is a potent photosensitizing agent, that once activated transfer this energy directly to oxygen, resulting in the formation of singlet oxygen. It has beendemonstrated as a potent photosensitizer used to eliminate Candida albicans, Streptococcus sanguis and Streptococcus mutans. It has also been proved in an in vitro study, to be effective against periodontopathogens like Porphyromonas gingivalis. However, there are no clinical studies assessing the efficiency of rose bengal mediated photodynamic therapy in treating peri implantitis . In this context, the present randomized controlled clinical trial has been carried out to ascertain the efficiency of rose bengal mediated photodynamic therapy as an adjunct to non-surgical management of peri implantitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1 patients above or equal to 20years of age.
- •2 Absence of relevant medical conditions.
- •3 Initial peri-implantitis a pocket probing depth (PPD) of 4–6 mm with concomitant bleeding on probing (BoP) at 1 peri-implant site and radiographic marginal bone loss ranging from 0.5 to 2 mm between delivery of the suprastructure and pre-screening appointment.
- •4 Implant in function for at least 1 year.
- •5 Solid screw bone level titanium implants with sandblasted and acid etched surface (Straumann dental implant system).
排除标准
- •(1) Uncontrolled medical conditions.
- •(2) Pregnant or lactating females.
- •(3) Tobacco smoking.
- •(4) Untreated periodontal conditions.
- •(5) Use of antibiotics in the past 3 months.
- •(6) Subjects treated for more than 2 weeks with any medication known to affect soft tissue conditions (e.g. phenytoin, calcium antag- onists, cyclosporin, coumadin and non- steroidal anti-inflammatory drugs) within 1 month of the baseline examination.
- •(7) Peri-implant mucositis defined as the absence of radiographic marginal bone loss between delivery of the suprastructure and pre-screening appointment.
- •(8) Failure to sign written informed consent.
结局指标
主要结局
1) Pocket Probing Depth (PPD).
时间窗: Baseline | 3 months | 6 months
(2) Clinical Attachment Level (CAL).
时间窗: Baseline | 3 months | 6 months
(3) Mucosal recession (REC).
时间窗: Baseline | 3 months | 6 months
(4) Bleeding on Probing (BoP)
时间窗: Baseline | 3 months | 6 months
(5) Modified Plaque Index (mPlI)
时间窗: Baseline | 3 months | 6 months
次要结局
- Microbial colony count(Inflammatory bio marker levels)
研究者
Nivedha N
Saveetha dental college and hospital, SIMATS University
