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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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

76

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Haryana
      • Rohtak, Haryana, India, 124001

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Plaque Index
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PROBING POCKET DEPTH (PPD)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Saurav Singh Perio 26/61

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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