Analysis of the Effectiveness of the Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol: a Factorial Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Plaque on implant abutment
研究概览
简要总结
Dental implants are widely employed in modern dentistry for the rehabilitation of patients affected by edentulism, whether limited to a single missing tooth, multiple adjacent teeth, or involving complete dental arches. In particular, full-arch rehabilitations provide both functional and aesthetic restoration of completely edentulous arches or of severely compromised dentitions that the preservation of the remaining teeth is no longer clinically feasible.
Among the various treatment strategies available, the Columbus Bridge Protocol™ represents an established implant-prosthetic approach for full-arch rehabilitation through the use of implant-supported prostheses with immediate functional loading.
The non-surgical management of peri-implant diseases can be performed using a variety of tools, which are considered equivalent in effectiveness when used individually, according to the Guidelines for the Prevention and Treatment of Peri-implant Diseases. These include ultrasonic devices with implant-specific tips, titanium curettes, chitosan brushes, and air-polishing systems using glycine-based powders.
These instruments effectively remove biofilm and deposits without compromising the implant surface, unlike stainless steel curettes, which can induce microscopic alterations. Such alterations may facilitate microbial colonization and complicate effective biofilm removal.
In particular, for the removal of soft deposits, air-polishing devices with glycine powder have been shown to reduce clinical signs of inflammation in cases of peri-implant mucositis and may enhance the efficacy of non-surgical therapy in peri-implantitis. Furthermore, the use of fine-grain powders such as glycine does not cause surface alterations to the hard tissues of natural teeth or to titanium implant surfaces, nor does it lead to epithelial erosion of the soft tissues.
In patients with full-arch implant-supported prostheses, air-polishing devices represent an effective method for professional oral hygiene, including the prosthetic-mucosal interface, without requiring prosthesis removal.
Regarding home oral hygiene, the Guidelines for the Prevention and Treatment of Peri-implant Diseases do not provide universally applicable recommendations. Instead, they emphasize the importance of personalized instructions and motivation strategies, tailored to the individual needs of each patient.
For patients rehabilitated with full-arch implant-supported prostheses, in addition to compliance, prosthetic design must ensure adequate cleanability. Ideally, designs should avoid the reconstruction of soft tissues, thereby facilitating daily hygiene procedures.
The primary home-care tools recommended for these patients include manual or electric toothbrushes, sponge dental floss, and interdental brushes. The use of an angled toothbrush has also been suggested to improve access to difficult areas, such as prosthetic surfaces in direct contact with the mucosa and distal cantilevers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good general health (classified as ASA Physical Status ≤ 2, according to the American Society of Anesthesiology),
- •patients with implant-supported prosthetic rehabilitation completed following the Columbus Bridge Protocol at least six months prior to enrollment
排除标准
- •patients under the age of 18; heavy tobacco smokers (≥10 cigarettes per day);
- •pregnant or breastfeeding women;
- •individuals with autoimmune diseases, with or without oral tissue involvement;
- •patients presenting biological complications (such as lack of osseointegration, implant mobility, or implant loss) affecting one or more implants;
- •cases of peri-implantitis involving at least one implant; individuals with less than 40% peri-implant bone support as measured radiographically;
- •patients taking medications known to induce gingival overgrowth, as well as those undergoing corticosteroid or antibiotic therapy in the three months prior to and during the study period, or receiving antiresorptive drug therapy;
- •individuals with motor, manual, or cognitive impairments;
- •patients whose full-arch implant-supported rehabilitation had been performed at other facilities;
- •individuals with respiratory disorders; and those diagnosed with infectious diseases.
研究组 & 干预措施
professional oral hygiene with glycine and domiciliary oral hygiene with angle toothbrush
Patients randomized to the Test group for professional oral hygiene underwent professional removal of hard and soft deposits using titanium curettes, spongy interdental floss, and air-polishing with glycine powder. The glycine powder used had a particle size of 25 μm and was applied using a supragingival nozzle positioned 3 mm from the prosthetic restoration, with particular attention given to the areas in direct contact with the mucosa.
Patients randomized to the Test group for domiciliary oral hygiene procedures - were motivated and instructed to use an angled-handle toothbrush (Specialist Implant, Curasept S.p.A., Saronno, Italy), in addition to a standard toothbrush and implant floss. The specific design of the angled handle was intended to facilitate access to areas that are difficult to clean. In patients rehabilitated with full-arch implant-supported prostheses, these areas typically include distal cantilevers and surfaces in direct contact with the mucosa.
干预措施: Professional oral hygiene with glycine powder (Procedure)
professional oral hygiene with glycine and domiciliary oral hygiene with angle toothbrush
Patients randomized to the Test group for professional oral hygiene underwent professional removal of hard and soft deposits using titanium curettes, spongy interdental floss, and air-polishing with glycine powder. The glycine powder used had a particle size of 25 μm and was applied using a supragingival nozzle positioned 3 mm from the prosthetic restoration, with particular attention given to the areas in direct contact with the mucosa.
Patients randomized to the Test group for domiciliary oral hygiene procedures - were motivated and instructed to use an angled-handle toothbrush (Specialist Implant, Curasept S.p.A., Saronno, Italy), in addition to a standard toothbrush and implant floss. The specific design of the angled handle was intended to facilitate access to areas that are difficult to clean. In patients rehabilitated with full-arch implant-supported prostheses, these areas typically include distal cantilevers and surfaces in direct contact with the mucosa.
干预措施: Domiciliary oral hygiene with angle toothbrush (Device)
professional oral hygiene with glycine and domiciliary oral hygiene with standard toothbrush
Patients randomized to the Test group for professional oral hygiene underwent professional removal of hard and soft deposits using titanium curettes, spongy interdental floss, and air-polishing with glycine powder. The glycine powder used had a particle size of 25 μm and was applied using a supragingival nozzle positioned 3 mm from the prosthetic restoration, with particular attention given to the areas in direct contact with the mucosa.
Patients randomized to the Control group for domiciliary oral hygiene procedures were motivated exclusively to use a standard toothbrush and implant floss.
干预措施: Professional oral hygiene with glycine powder (Procedure)
professional oral hygiene without glycine and domiciliary oral hygiene with angle toothbrush
Patients randomized to the Control group for professional oral hygiene underwent professional removal of hard and soft deposits exclusively by means of titanium curettes and spongy interdental floss.
Patients randomized to the Test group for domiciliary oral hygiene procedures - were motivated and instructed to use an angled-handle toothbrush (Specialist Implant, Curasept S.p.A., Saronno, Italy), in addition to a standard toothbrush and implant floss. The specific design of the angled handle was intended to facilitate access to areas that are difficult to clean. In patients rehabilitated with full-arch implant-supported prostheses, these areas typically include distal cantilevers and surfaces in direct contact with the mucosa.
干预措施: Domiciliary oral hygiene with angle toothbrush (Device)
professional oral hygiene without glycine and domiciliary oral hygiene with standard toothbrush
Patients randomized to the Control group for professional oral hygiene underwent professional removal of hard and soft deposits exclusively by means of titanium curettes and spongy interdental floss.
Patients randomized to the Control group for domiciliary oral hygiene procedures were motivated exclusively to use a standard toothbrush and implant floss.
结局指标
主要结局
Plaque on implant abutment
时间窗: 3 months
Plaque Index was recorded on the implants prior to the implementation of any procedure that could potentially lead to biofilm removal, evaluating six sites per implant. The absence or presence of plaque will be assessed using a periodontal probe. Scores can range from 0 (no tooth surfaces with plaque) to 100 (all tooth surfaces have plaque), where 100 is the worst possible result.
次要结局
- Bleeding on probing on implant abutment(3 months)
- Plaque on prosthesis(3 months)
- Probing depth on implant abutment(3 months)
- Keratinized mucosa(3 months)
研究者
Jacopo Lanzetti
Doctor in Dental Hygiene
University of Turin, Italy