Efficacy of Biofilm Removal of Different Interproximal Oral Hygiene Devices Around Posterior Single Implants. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Biofilm reduction
研究概览
简要总结
The objective of this clinical trial is to determine which interproximal hygiene device is most effective at eliminating dental plaque on implants. The main questions to be answered are:
Which interproximal hygiene device is most effective in reducing dental plaque (dental floss, superfloss, irrigator, or interproximal brush)? The researchers will compare the different devices using a plaque disclosing agent and standardized photography.
Participants:
Participants will attend a visit where the screw-retained crown will be removed, and the subgingival area will be stained with a plaque disclosing agent. The first photograph will be taken, and then the crown will be replaced. Subsequently, one of the four methods will be used randomly. The crown will be removed again, and a second photograph will be taken.
详细描述
The present investigation was designed as a randomized clinical trial and approved by the Ethics Committee of the Universitat Internacional de Catalunya (Barcelona, Spain) (Protocol reference PER-ECL-2019-01). The study was performed in accordance with the Declaration of Helsinki for research involving humans. After being informed about the study procedures, all patients read and signed an appropriate informed consent document prior to being included. The CONSORT guidelines for randomized clinical trials were followed.
Participants:
Periodontally healthy patients with at least one single screw-retained implant-supported crown (loaded for more than one year) on a molar or premolar site with neighboring teeth were recruited. The implants had to present ≤ 4 mm of probing pocket depth and have an appropriate prosthetic design allowing proper oral hygiene. Subjects were excluded under the following conditions: (1) drug consumption that could cause gingival enlargement, such as phenytoin, cyclosporin, and/or calcium channel blockers; (2) presence of uncontrolled diabetes mellitus; (3) smokers; (4) presence or signs of peri-implant diseases or uncontrolled periodontal disease; and (5) prosthetic design that did not allow for proper interproximal hygiene (determined by using the smallest size of interproximal brush).
One calibrated investigator (C.T.) consecutively evaluated patients for screening and was responsible for enrollment. The clinician conducted an anamnesis of the patient's medical history and recorded the clinical information.
Subsequently, patients were randomly assigned to one of the following treatment groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontally healthy patients with at least one single screw-retained implant-supported crown (loaded for more than one year) on a molar or premolar site with neighboring teeth were recruited. The implants had to present ≤ 4 mm of probing pocket depth and have an appropriate prosthetic design that allowed for proper oral hygiene.
排除标准
- •Drug consumption that could cause gingival enlargement, such as phenytoin, cyclosporin, and/or calcium channel blockers.
- •Presence of uncontrolled diabetes mellitus. Smokers. Presence or signs of peri-implant diseases or uncontrolled periodontal disease. Prosthetic design that did not allow for proper interproximal hygiene (determined by using the smallest size of interproximal brush).
研究组 & 干预措施
• Dental Floss (Vitis®, Dentaid, Barcelona, Spain).
dental floss is used as interproximal hygiene device. The intervention includes thorough instruction on the correct flossing technique around dental implants to ensure effective removal of plaque and debris. Participants will be supplied with dental floss and given detailed guidance on integrating flossing into their daily oral hygiene regimen. The effectiveness of this method will be evaluated by measuring plaque levels before and after the intervention.
干预措施: • Dental Floss (Vitis®, Dentaid, Barcelona, Spain). (Device)
• Superfloss (Oral B®, Procter & Gamble, USA)
superfloss is used as the primary interproximal hygiene device. Superfloss is designed to clean around dental implants, bridges, and wide spaces between teeth. Participants will receive instructions on how to effectively use superfloss, which includes its unique combination of foam, regular floss, and spongy material to remove plaque and debris. The intervention will focus on demonstrating the proper technique to ensure optimal cleaning. The effectiveness of this method will be evaluated by comparing plaque levels before and after the intervention.
干预措施: • Superfloss (Oral B®, Procter & Gamble, USA) (Device)
• Oral irrigator (Waterpick®, Water Pik, Inc., CO., USA)
oral irrigator used as the primary interproximal hygiene device. The oral irrigator delivers a stream of pulsating water to help remove plaque and food particles from around dental implants and between teeth. Participants will receive guidance on how to properly use the oral irrigator, including the appropriate pressure settings and angles for effective cleaning. The intervention aims to enhance oral hygiene by providing a thorough rinse of the interproximal areas. The effectiveness of this method will be assessed by comparing plaque levels before and after the intervention.
干预措施: • Oral irrigator (Waterpick®, Water Pik, Inc., CO., USA) (Device)
• Interproximal brushes (Interprox®, Vitis, Dentaid, Spain)
interproximal brush is used as the primary interproximal hygiene device. The interproximal brush is specifically designed to clean between teeth and around dental implants, effectively removing plaque and debris in areas that traditional toothbrushes may miss. Participants will receive instructions on how to select the appropriate brush size and how to use it effectively to ensure optimal cleaning. The intervention will emphasize the importance of thorough brushing technique for maintaining oral health. The effectiveness of this method will be evaluated by comparing plaque levels before and after the intervention.
干预措施: • Interproximal brushes (Interprox®, Vitis, Dentaid, Spain) (Device)
结局指标
主要结局
Biofilm reduction
时间窗: Immediate Post-Treatment Evaluation: Directly after the treatment is completed to assess immediate effects.
In the first photograph, the total area within the drawn margin was calculated.Subsequently, the erythrosine-coloured area was delimited, determining the biofilm percentage (Pre-area). In the second picture, the residual stained area (Post-area) was calculated in the same way. The percentage reduction of plaque between the two images was then calculated
次要结局
未报告次要终点
研究者
Andres Pascual La Rocca
DDS , PhD, Professor
Universitat Internacional de Catalunya