Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Bleeding on probing (BOP)
研究概览
简要总结
This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.
详细描述
Clinical signs of inflammation in peri-implantitis include bleeding on probing, suppuration, increased probing depth, and radiographic signs of bone loss. Currently, the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants, and comprehensive guidance on self-performed infection control procedures. With more advanced peri-implantitis, anti-infective surgical treatment protocol would be needed.
Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test.
The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The method mechanism of action is antibacterial photodynamic therapy (aPDT). The method is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The first assessments will be made before randomization.
After the randomization, there is no masking.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PPD ≥6 mm and marginal bone loss >3 mm
- •Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22
- •Agreement to participate in the study and to sign a written consent form
- •Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
排除标准
- •Presence of any physical limitation or restriction that might restrict Lumoral use
- •Unwilling to participate in the study
- •Pregnancy or lactation
- •Active smoking
- •Medicated diabetes mellitus (DM)
- •Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis
- •Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation
- •Peri-implant and periodontal treatment within 3 months prior to study participation
- •Removable major prosthesis or major orthodontic appliance
研究组 & 干预措施
Non-surgical treatment, Study group (NST-1)
Lumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: Scaling and root planing (SRP (Procedure)
Non-surgical treatment, Control group (NST-2)
Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: Standard oral hygiene instructions (Procedure)
Surgical treatment, Study group (ST-1)
Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: Standard oral hygiene instructions (Procedure)
Surgical treatment, Study group (ST-1)
Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: surgical anti-infective peri-implantitis treatment (Procedure)
Surgical treatment, Control group (ST-2)
Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: Standard oral hygiene instructions (Procedure)
Surgical treatment, Control group (ST-2)
Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: surgical anti-infective peri-implantitis treatment (Procedure)
Non-surgical treatment, Study group (NST-1)
Lumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: Lumoral Treatment (Device)
Non-surgical treatment, Study group (NST-1)
Lumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: Standard oral hygiene instructions (Procedure)
Non-surgical treatment, Control group (NST-2)
Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: Scaling and root planing (SRP (Procedure)
Surgical treatment, Study group (ST-1)
Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
干预措施: Lumoral Treatment (Device)
结局指标
主要结局
Bleeding on probing (BOP)
时间窗: 6 months
Change in the inflammatory parameter BOP. A full-mouth assessment at six sites per tooth: * Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus * Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" * BOP reported as the percentage (%) of sites with positive findings * Calculation formula: number of bleeding sites/ 6 times number of teeth
次要结局
- Active matrix metalloproteinase 8 (aMMP-8)(6 months)
- Inflammatory marker total MMP-2 analysis(6 months)
- Adverse events(6 months)
- Bacterial flora(6 Months)
- Inflammatory marker total MMP-8 analysis(6 months)
- Inflammatory marker total MMP-9 analysis(6 months)
- Inflammatory marker total TIMP analysis(6 months)
- Peridontal Pocket Depth (PPD)(6 months)
- Interleukins analysis(6 months)
- Total calprotectin analysis(6 months)
- Visual Plaque Index( VPI)(6 months)
- OHIP-14 questionnaire(6 months)
- Clinical Attachment Level (CAL)(6 months)
研究者
Nilminie Rathnayake
Principal Investigator
Koite Health Oy