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Effect of Mobile Health on Plaque Control Efficacy in Molars With Furcation Involvement

Effect of Mobile Health on Plaque Control Efficacy in Molars With Furcation Involvement: A Randomized Controlled Clinical Trial

Furcation involvement (FI) refers to a condition in which the progression of the periodontal disease process invades the bifurcation and trifurcation of multirooted teeth. Furcation involvement, present a clinical challenge due to its anatomic complexity and reduced access for adequate plaque control which may leads to further periodontal breakdown. Consequently, maintenance of adequate oral hygiene is critical in these sites.

It has been shown that poor oral hygiene, together with the persistence of periodontal risk factors, leads to further disease progression, treatment failure, and disease recurrence.

Mobile health can serve as a valuable adjunctive approach by aiding in behavioral reinforcement through real-time reminders. With widespread mobile phone usage in India, mHealth interventions are feasible. The role of mHealth in management of furcation involved sites has still not been explored. Therefore, this randomized controlled clinical trial aims to evaluate the effectiveness of mobile health reinforcements in improving plaque control efficacy at in furcation involved sites following non-surgical periodontal therapy, with the potential to enhance patient compliance and prevent further disease progression and disease recurrence.

研究概览

详细说明

Furcation involvement (FI) is recognized as one of the most critical factors determining the complexity and prognosis of periodontitis affecting molar teeth. The etiologies of furcation involvement may include anatomic factors, extension of inflammatory periodontal diseases, trauma from occlusion, pulpo-periodontal diseases, and root fracture involving furcation. Several morphological characteristics of roots and furcation lead to poor prognosis of affected teeth. When left untreated, periodontal destruction in furcation areas tends to progress horizontally toward the central portion of the furcation as well as vertically in an apical direction along the root surfaces. Inadequate plaque control in anatomically complex furcation areas causes persistent inflammation which may cause progression of interradicular bone loss.

The prevalence of furcation involvement in mandibular molars was 50% in the population aged 40 years and above. The prevalence of advanced furcation involvement in mandibular first molars showed no significant difference between buccal and lingual sites. Molar teeth with furcation involvement are the most commonly lost.

The anatomical complexity of furcation makes plaque control difficult. Several microbes present in plaque lead to progression of periodontitis and lead to accelerated alveolar bone loss. The use of interdental aids as an adjunct to routine oral hygiene instructions has been advised for plaque control in the furcal areas, as they have been known to decrease subgingival bacterial count and gingival inflammation, and may decrease the possibility of further progress of periodontal disease in these affected sites. However, poor compliance with interdental hygiene measures due to lack of perceived benefits serves as a deterrent to effective plaque control.

Mobile health (mHealth) is defined by the World Health Organization (WHO) as "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices." India has approximately 1.15 billion mobile phone subscribers, comprising nearly 625 million urban and 524 million rural users, and ranks second globally in mobile phone connectivity, making the integration of mHealth into healthcare delivery highly feasible. mHealth offers real-time communication between patients and healthcare providers, thereby enhancing treatment delivery and follow-up. Evidence from the medical field suggests that mHealth interventions can be effective adjuncts in patient self-management, particularly in chronic conditions such as type 2 diabetes. In dentistry, the use of mHealth as an adjunctive tool in the management of gingivitis and in improving daily self-performed oral hygiene practices has been documented in previous literature.

Research indicates that regular prompts and reminders are effective in promoting and reinforcing healthy habits. The average time required to form a habit is approximately 66 days, with a reported range of 18 to 254 days. In periodontal patients, improvements in oral hygiene performance have been attributed to repetition and reinforcement of oral hygiene instructions. It has been documented that text messaging is effective in promoting behavioral change in the management of chronic diseases. Text messages facilitate behavioral modification and enhance health knowledge by providing guidance, warnings, reminders, positive reinforcement, and feedback. Furthermore, text messaging interventions have demonstrated effectiveness in the prevention and management of conditions such as obesity, smoking, and diabetes.

So, in the view of current literature, the investigator hypothesis that mobile health reinforcements can contribute to improved compliance in oral hygiene behaviors in patients presenting with sites with furcation involvement which may prevent the progression of periodontal disease. To the best of their knowledge, no study till date has been conducted assessing the effectiveness of Mobile Health in sites affected by furcation involvement in improving their oral hygiene after nonsurgical periodontal therapy. So this Randomized controlled Clinical Trial aims to clinically evaluate the effectiveness of Mobile Health in sites affected by furcation involvement in improving efficacy of plaque control after non-surgical periodontal therapy.

Individuals with clinically visible furcation entrance in mandibular molars with Stage III periodontitis will be assigned into 2 groups. Individuals in both the groups will undergo phase I therapy including supragingival and subgingival scaling with a combination of hand scalers and micromini curettes (Hu Friedy) and ultrasonic scaler (EMS Piezon,250, Switzerland) along with standardized oral hygiene instructions and interradicular brushing.

In the experimental group, regular messages twice a week will be sent to the individuals reminding the individuals for standardized oral hygiene instructions and interradicular brushing in furcation involvement. Individuals will be asked to respond to the messages In the comparator group, standardized oral hygiene instructions and interradicular brushing in furcation involvement individuals will be given at follow up appointments.

Patient Compliance will be assessed by the use of Daily diary method.

研究类型

介入性

注册 (估计的)

76

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Haryana
      • Rohtak、Haryana、印度、124001

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Systemically healthy individuals with clinically visible furcation entrance in mandibular molars in Stage III periodontitis
  • Horizontal bone loss extent ≥ 3mm29 and vertical bone loss ( Subclass A/B)30
  • Access to mobile phone

Exclusion Criteria:

  • Presence of systemic diseases that could influence the outcome of periodontal therapy (Diabetes mellitus, Hypertension)
  • Smoking/alcohol consumption
  • Teeth with Grade II/III mobility
  • History of periodontal treatment or antibiotic therapy in the last 6 months
  • Non-vital and carious teeth to be restored
  • Physically and mentally impaired patients
  • Furcation involvement with cervical enamel projections, enamel pearls and bifurcation ridges

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Messages + Oral hygiene Instructions
Regular messages twice a week will be sent to the individuals reminding the individuals for standardized oral hygiene instructions and interradicular brushing in furcation involvement.
Regular messages twice a week will be sent to the individuals reminding the individuals for standardized oral hygiene instructions and interradicular brushing in furcation involvement. Individuals will be asked to respond to the messages.
All participants will recieve standardized oral hygiene instructions including toothbrushing techniques and interdental brushes.
有源比较器:Oral hygiene Instructions
Standardized oral hygiene instructions and interradicular brushing in furcation involvement individuals will be given at follow up appointments.
All participants will recieve standardized oral hygiene instructions including toothbrushing techniques and interdental brushes.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Plaque Index
大体时间:6 months
Plaque index by Silness and Loe (1964) will be used for assessment of plaque.Score range of this index is from 0 to 3.Score 0 means good oral hygiene and score 3 means poor oral hygiene.
6 months
Bleeding on probing
大体时间:6 months
It will be measured by walking the periodontal probe at 6 sites of each tooth (mesio-buccal, mid-buccal, disto-buccal, mesio- lingual, mid-lingual and disto-lingual). It will be recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %.
6 months

次要结果测量

结果测量
措施说明
大体时间
PROBING POCKET DEPTH (PPD)
大体时间:6 months
Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe. The probe will be inserted in the bottom of pocket and maintained parallel to vertical axis of the tooth. Measurements will be noted at 6 sites of a tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual). Measurements will be rounded to the nearest whole millimeter.
6 months
HORIZONTAL PROBING DEPTH (HPD)
大体时间:6 months
Horizontal probing depth will be assessed by probing the furcation in a horizontal direction using a rigid curved probe (e.g. Nabers probe) and measuring the distance from the probe tip to a virtual tangent to the root convexities adjacent to the furcation. Measuring this distance allows assessment of different degrees of FI or the amount of horizontal attachment loss in millimeters (horizontal probing/ clinical attachment level: PAL-H/HCAL).
6 months
VERTICAL PROBING DEPTH (HPD)
大体时间:6 months
UNC-15 periodontal probe will be used to record the vertical depth. The probe will be inserted into the periodontal pocket up to the alveolar bone, and the distance from the roof of furcation to the vertical depth of probing (VD) will be measured. All measurements will be recorded nearest to the millimeter.
6 months
CLINICAL ATTACHMENT LEVEL(CAL)
大体时间:6 months
Clinical attachment level will be measured as the distance between the cemento-enamel junction and the base of pocket. Measurements will be made at 6 sites of each tooth (mesio-buccal, mid-buccal, disto-buccal, mesio- lingual, mid-lingual and disto-lingual) using Periodontal probe. Distance of base of the pocket from gingival margin, distance of free gingival margin from CEJ will be measured. Afterwards CAL will be calculated based on following criteria. When gingival margin is located on the anatomic crown, the level of attachment is determined by subtracting from the depth of pocket, the distance from the gingival margin to the CEJ. If both are same, the loss of attachment is recorded as zero. When gingival margin coincides with CEJ, the loss of attachment equals to probing pocket depth. When gingival margin is located apical to CEJ, the loss of attachment is greater than probing depth and therefore the distance between CEJ and gingival margin is adde
6 months
GINGIVAL INDEX (GI)
大体时间:6 months

Gingival index by Loe and Silness (1963) will be used to assess severity of gingival inflammation. Measurements will be taken at 4 sites of each tooth (buccal, lingual, mesial and distal).

0- Absence of inflammation.

  1. Mild inflammation - slight change in color and little change in texture.
  2. Moderate inflammation - moderate glazing, redness, oedema. and hypertrophy. Bleeding on pressure.
  3. Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Saurav Singh Perio 26/61

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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