- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07642895
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: SAURAV SINGH
- Telefonní číslo: +91-8851984435
- E-mail: sauravsinghpal.2000@gmail.com
Studijní záloha kontaktů
- Jméno: Nishi Tanwar
- Telefonní číslo: +91-8368126310
- E-mail: nsh_tanwar@yahoo.co.in
Studijní místa
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Haryana
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Rohtak, Haryana, Indie, 124001
- PGIDS, Rohtak
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Kontakt:
- Nishi Tanwar
- Telefonní číslo: +91-8368126310
- E-mail: nsh_tanwar@yahoo.co.in
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
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Aktivní komparátor: Oral hygiene Instructions
Standardized oral hygiene instructions and interradicular brushing in furcation involvement individuals will be given at follow up appointments.
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All participants will recieve standardized oral hygiene instructions including toothbrushing techniques and interdental brushes.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Plaque Index
Časové okno: 6 months
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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.
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6 months
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Bleeding on probing
Časové okno: 6 months
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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 %.
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6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PROBING POCKET DEPTH (PPD)
Časové okno: 6 months
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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.
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6 months
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HORIZONTAL PROBING DEPTH (HPD)
Časové okno: 6 months
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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).
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6 months
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VERTICAL PROBING DEPTH (HPD)
Časové okno: 6 months
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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.
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6 months
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CLINICAL ATTACHMENT LEVEL(CAL)
Časové okno: 6 months
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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
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6 months
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GINGIVAL INDEX (GI)
Časové okno: 6 months
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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.
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6 months
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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