- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07650747
Effectiveness of the Touch-to-Teach Method for Interdental Brushing in Patients With Stage II Grade B Periodontitis.
10. juni 2026 opdateret af: Gulf Medical University
Effectiveness of the Touch-to-Teach Method for Interdental Brushing in Patients With Stage II Grade B Periodontitis. A Randomized Clinical Trial
In 2018, a collaboration between American Academy of Periodontology (AAP) and European Federation of Periodontology (EFP) yielded a new classification system for periodontal diseases and conditions.
The new classification categorized periodontitis into stages from I to IV based on the severity of the disease.
Besides the stages, cases were also categorized into A, B and C grades based on the probable progression of the disease.
Likewise, cases with interproximal clinical attachment loss of 3-4 mm in the worst affected teeth are considered to be stage II periodontitis.[3]
These patients usually do not have tooth loss, can be suffering from localized or generalized type and mostly show horizontal bone loss.
There are three types of gingival embrasures.
In type I embrasure, the gingival embrasure is filled by the interproximal papilla; whereas in type II and III embrasures interdental papilla loss is seen.
Interdental brushing has a vital role in maintaining good oral hygiene and previously published reports have evidenced that successful interdental brushing eliminated interdental plaque below the gingival margin up to 2-2.5 mm.
According to the old school of thought, dental floss was advised for type I embrasures, interdental brushes for type II embrasures and unitufted brushes for type III embrasures.
Usage of dental floss has been identified to be cumbersome and especially challenging in posterior regions of the oral cavity.
Additionally, a recent systematic review in the Cochrane database highlighted the effectiveness of interproximal brushes over dental floss.[9]
Recently, the implementation of calibrated interdental brushes use with the availability of interdental brushes with varying sizes, added effectively in creating a healthy interdental papilla in a safe manner.
Essentially, a patient-centered and personalized approach named "individually trained oral prophylaxis (iTOP)" has recently been suggested as a solution to remove dental plaque effectively.[10]
This concept known as the "Touch-to-Teach" concept provides the patients with an effective method to educate the patients an effective and non-traumatic way of removing interdental plaque.[10]
Although, the effectiveness of calibrated interdental brushes showed high efficacy in cases of gingivitis, currently, the effectiveness of these brushes in stage II periodontitis has not been comprehensively studied yet in literature.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Ajman, Forenede Arabiske Emirater
- Gulf Medical University
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Patients with generalized Stage II periodontitis, diagnosed based on the 2018 classification of periodontal diseases and conditions.[7]
- Patients with presence of interproximal clinical attachment loss of ≥ 3-4 mm was used for the diagnosis of periodontitis.
- Patients with more than 30% of sites with true periodontal pockets of more than 4 mm with bleeding on probing in the interproximal region.
Exclusion Criteria:
- Patients with uncontrolled diabetes mellitus,
- Patients smoking ≥ 10 cigarettes per day.
- Patients who have undergone scaling and root debridement within the past six months
- Patients who were on antimicrobial therapy in the past three months
- Patients who were on regular use of anti-plaque mouth rinses in the past three months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Interproximal standard hygiene care control group:
The control group was provided with standard oral hygiene instructions (Bass method) and videos regarding maintenance of interdental oral hygiene were provided.
Videos regarding oral hygiene maintenance were downloaded from the website of the EFP.
Briefly, these animated videos are generated from PerioPixel, which specializes in the generation of animated videos in dentistry, explaining the different oral hygiene techniques and treatments for gingival and periodontal diseases.
|
The control group was provided with standard oral hygiene instructions (Bass method) and videos regarding maintenance of interdental oral hygiene were provided.
Videos regarding oral hygiene maintenance were downloaded from the website of the EFP.
Briefly, these animated videos are generated from PerioPixel, which specializes in the generation of animated videos in dentistry, explaining the different oral hygiene techniques and treatments for gingival and periodontal diseases.
|
|
Eksperimentel: Interproximal "Touch-to-Teach" method hygiene care test group
The test group received interdental hygiene care using the "Touch-to-Teach" method.
The Curaprox chairside system includes a range of color-coded interdental brushes selected according to the size of the patient's interdental spaces.
The brushes are color-coded as blue, red, pink, yellow, and green, with blue with an interdental accessibility diameter of 0.6m, 0.7 mm, 0.8 mm, 0.9 mm, and 1.1 mm respectively .
The kit also contains color-coded colorimetric probes (interdental access probes) that can be used to measure the size of the interproximal space.
|
The test group received interdental hygiene care using the "Touch-to-Teach" method.
The Curaprox chairside system includes a range of color-coded interdental brushes selected according to the size of the patient's interdental spaces.
The brushes are color-coded as blue, red, pink, yellow, and green, with blue with an interdental accessibility diameter of 0.6m, 0.7 mm, 0.8 mm, 0.9 mm, and 1.1 mm respectively.
The kit also contains color-coded colorimetric probes (interdental access probes) that can be used to measure the size of the interproximal space.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Plaque index
Tidsramme: baseline and 3 months
|
baseline and 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bleeding index
Tidsramme: baseline and 3 months
|
baseline and 3 months
|
|
|
Patient Satisfaction VAS scale 0-5
Tidsramme: 3 months
|
VAS scale 0-5
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2025
Primær færdiggørelse (Faktiske)
1. februar 2026
Studieafslutning (Anslået)
10. juni 2026
Datoer for studieregistrering
Først indsendt
7. juni 2026
Først indsendt, der opfyldte QC-kriterier
10. juni 2026
Først opslået (Faktiske)
16. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2022MDSPerio04
Plan for individuelle deltagerdata (IPD)
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-
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