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Набор скоро начнётся NCT07642895

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

Без фазы С лечением Furcation Defects

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Behavioural text messages twice weekly, Standardized oral hygiene instructions.
Кому может быть актуально
Состояния в реестре: Furcation Defects. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Behavioural text messages twice weekly
    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.
  • Другое Standardized oral hygiene instructions
    All participants will recieve standardized oral hygiene instructions including toothbrushing techniques and interdental brushes.

Первичные конечные точки

  • Plaque Index [Срок оценки: 6 months]
  • Bleeding on probing [Срок оценки: 6 months]
Вторичные конечные точки (5)
  • PROBING POCKET DEPTH (PPD) [Срок оценки: 6 months]
  • HORIZONTAL PROBING DEPTH (HPD) [Срок оценки: 6 months]
  • VERTICAL PROBING DEPTH (HPD) [Срок оценки: 6 months]
  • CLINICAL ATTACHMENT LEVEL(CAL) [Срок оценки: 6 months]
  • GINGIVAL INDEX (GI) [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Индия · 1 центр
  • PGIDS, Rohtak — Rohtak

Идентификаторы

NCT: NCT07642895 · Saurav Singh Perio 26/61

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗