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临床试验/NCT05565404
NCT05565404招募中不适用

Effect of Mobile Health(mHealth) on Interdental Brushing in Type 2 Embrasures": A Randomized Controlled Clinical Trial.

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
Papillary Bleeding Index

研究概览

简要总结

Plaque biofilm is the etiological factor for the development of gingival and periodontal diseases. There are certain areas in mouth where plaque removal is difficult, which includes palatal, lingual and interproximal areas. Among these, interproximal areas are most difficult to clean due to inability of toothbrush to reach that area properly. So, interdental aids are required to remove plaque from the proximal areas efficiently. Consequently, plaque accumulation most often starts in interdental areas, where resultant periodontal lesions are observed most commonly. It is the ethical responsibility of the dental professional to educate patients about the progression of destructive periodontal disease, so that patients understand the need for plaque removal and control. It is not easy for patients to develop any new habits of using different cleaning aids. Many studies have proven mobile health to be effective in improving patient's compliance for better oral hygiene maintenance. So, proper means of education such as mobile health could lead to behavior change and adoption of new habit of using interdental aid on regular basis. Use of mobile technology to track and improve health outcomes is known as mobile health. No studies till date have evaluated mobile health in improving interdental brushing. It is possible that we can reinforce patient on the use of interdental brush with the help of text messages. Therefore, the present randomized controlled clinical trial is designed to evaluate the compliance of interdental brushing with the use of text messages.

详细描述

Dental plaque is considered to be a biofilm of dynamic and complex microbial community. Microbial composition of plaque varies in every individual and at every site within the same mouth. Plaque accumulation leads to development of gingival and periodontal diseases. It usually takes 7 to 21 days to develop gingivitis in the absence of plaque removal. Plaque control is necessary for maintaining the oral tissues, especially the gingiva, in a healthy state. Primary means of plaque control is through mechanical action, with the toothbrush being the most common means of plaque removal. While it removes plaque efficiently from the buccal, lingual and occlusal surfaces, it fails to do the same at interproximal sites. Consequently, plaque accumulation most often starts in interdental areas, where resultant periodontal lesions are observed most commonly. This makes interdental cleaning very necessary, in addition to toothbrushing, for prevention of gingival and periodontal diseases.

In type 2 embrasure patients, interdental brush is prescribed. It consists of soft nylon filaments twisted into a fine stainless steel wire. These interdental brushes are available in different sizes and shapes. The most common types are cylindrical or conical. They are available in different diameters according to interdental space, ranging from 1.9 to 14mm. Selected brush should be slightly larger than the embrasure space. Introduction of brush in interdental space should be done obliquely, from the apical direction and used with back-and-forth motion. In type 2 embrasure patients, interdental brush is prescribed. It consists of soft nylon filaments twisted into a fine stainless steel wire. These interdental brushes are available in different sizes and shapes. The most common types are cylindrical or conical. They are available in different diameters according to interdental space, ranging from 1.9 to 14mm. Selected brush should be slightly larger than the embrasure space. Introduction of brush in interdental space should be done obliquely, from the apical direction and used with back-and-forth motion.

Use of mobile phone has increased globally; over half of world's 6.5 billion people use mobile phone services. wireless subscription in India stands at 952.34 million (in urban 553.45million whereas in rural 398.89) at the end of January 2015. Use of mobile technology to improve health outcomes is known as mobile health (mHealth). Text messages have become very common now and can be used to educate and motivate patients. Studies in medicine and dentistry have shown that text messaging is a very efficient tool for behavioral change and disease prevention. Use of mobile phone has increased globally; over half of world's 6.5 billion people use mobile phone services. wireless subscription in India stands at 952.34 million (in urban 553.45million whereas in rural 398.89) at the end of January 2015. Use of mobile technology to improve health outcomes is known as mobile health (mHealth). Text messages have become very common now and can be used to educate and motivate patients. Studies in medicine and dentistry have shown that text messaging is a very efficient tool for behavioral change and disease prevention.

The present prospective, randomized controlled clinical trial will be conducted in the department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences, Rohtak, Haryana. Duration of study will be 12 to 14 months and Patients will be recruited from the outpatient department of Periodontology. It will be divided into two groups, Test group will include scaling and root planing, interdental brushing demonstration and text messages in type 2 embrasure patients and Control group will include scaling and root planing, interdental brushing demonstration in type 2 embrasure patients.

All the participants will undergo phase 1 therapy with a combination of hand scalers and curettes and ultrasonic scaler. Standardized oral hygiene instructions will be imparted and will be reinforced at each appointment.

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
Single (Investigator)

入排标准

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

入选标准

  • Patients with type 2 embrasures, with atleast 4 interdental spaces eligible for use of interdental brush.
  • 2 or 3 periodontitis with probing pocket depth ≤5mm.
  • Age - 30-55 years.
  • Patients who own mobile phones.
  • Patients who can read and write.
  • No history of performing interdental oral hygiene on regular basis.
  • Patients willing to comply with the given instructions regarding the use of interdental brush.

排除标准

  • Smokers and orthodontic patients.
  • Patient with systemic disease that can influence the outcome of therapy.
  • Physically and mentally impaired patients.
  • Patient on drugs associated with gingival overgrowth.
  • Pregnant females.
  • Patients on oral contraceptives or hormone replacement therapy.
  • Overhanging restorations.
  • Patients using any other cleaning aids like mouthwash.

结局指标

主要结局

Papillary Bleeding Index

时间窗: 6 months

* Papillary bleeding index by Saxer et al will be used to assess gingival bleeding. A blunt periodontal probe was carefully inserted into the gingival sulcus at the base of the papilla on the mesial aspect, then moved coronally to the papilla tip. This was repeated on the distal aspect of the same papilla. The intensity of any bleeding thus provoked was recorded on a 0-4scale. Score 0 No bleeding Score 1- A single discreet bleeding point appears Score 2 - Several isolated bleeding points or a single fine line of blood appears Score 3 - The interdental triangle fills with blood shortly after probing Score 4- Profuse bleeding occurs after probing blood flows immediately into the marginal sulcus

Plaque Index

时间窗: 6 months

Quigley \& Hein modification will be used which will measure the plaque level on buccal, labial and lingual surface of teeth with the help of disclosing agent.0 = no plaque 1. = separate flecks of plaque at the cervical margin of the tooth 2. = a thin continuous band of plaque (up to 1 mm) at the cervical margin 3. = a band of plaque wider than 1 mm but covering less than 1/3 of crown 4. = plaque covering at least 1 /3 but less than 2/3 of the crown 5. = plaque covering 2/3 or more of crown

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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