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- Klinische proef NCT07650747
Effectiveness of the Touch-to-Teach Method for Interdental Brushing in Patients With Stage II Grade B Periodontitis.
30 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
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Ajman, Verenigde Arabische Emiraten
- Gulf Medical University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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.
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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.
|
|
Experimenteel: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Plaque index
Tijdsspanne: baseline and 3 months
|
baseline and 3 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Bleeding index
Tijdsspanne: baseline and 3 months
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baseline and 3 months
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Patient Satisfaction VAS scale 0-5
Tijdsspanne: 3 months
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VAS scale 0-5
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3 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2025
Primaire voltooiing (Werkelijk)
1 februari 2026
Studie voltooiing (Werkelijk)
10 juni 2026
Studieregistratiedata
Eerst ingediend
7 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 juni 2026
Eerst geplaatst (Werkelijk)
16 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
30 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2022MDSPerio04
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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