The Effect of Using Plaque-disclosing Tablets on the Effectiveness of Toothbrushing and Gingival Health in Children
Effect of Single-Use Plaque-Disclosing Tablet Reinforcement on Plaque Control and Gingival Health in Children: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial evaluated whether a single at-home use of a plaque-disclosing tablet, as visual reinforcement following oral hygiene education, provides additional short-term benefits in plaque control and gingival health in children aged 10-14 years.
A total of 53 participants were randomized to a test group or a control group. All participants received plaque disclosure and standardized oral hygiene instruction including the modified Bass toothbrushing technique. Participants in the test group were additionally provided with one plaque-disclosing tablet to use on the fourth day after the initial visit, whereas the control group received no additional intervention. Plaque and gingival indices were recorded at baseline and again at the end of the first week.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Istanbul, Tyrkia (Türkiye)
- Istanbul Aydin University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Children aged 10-14 years
- Systemically and mentally healthy
- No antibiotic use within the previous 3 months
- No use of oral mouthrinse within the previous 4 weeks
- No previous periodontal treatment
- No known allergy or hypersensitivity to any component of the plaque-disclosing agent
- Written informed consent provided by a parent or legal guardian
- Voluntary assent provided by the child
Exclusion Criteria:
- Presence of any systemic or mental condition that could interfere with participation
- Antibiotic use within the previous 3 months
- Use of oral mouthrinse within the previous 4 weeks
- History of periodontal treatment
- Known allergy or hypersensitivity to any component of the plaque-disclosing agent
- Refusal of parental/legal guardian consent or child assent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Test
Standard oral hygiene education + baseline plaque disclosure + single plaque-disclosing tablet reinforcement on day 4. |
Participants received plaque disclosure followed by individualized visual feedback and standardized oral hygiene instruction using the modified Bass toothbrushing technique. Participants in the experimental arm were provided with one plaque-disclosing tablet and instructed to use it at home on the fourth day after the initial visit as a single visual reinforcement of the oral hygiene education. |
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Aktiv komparator: Control
Standard oral hygiene education + baseline plaque disclosure only. |
Participants received plaque disclosure followed by individualized visual feedback and standardized oral hygiene instruction using the modified Bass toothbrushing technique. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Quigley-Hein Plaque Index
Tidsramme: From enrollment to the end of treatment at 1 week
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Plaque accumulation was assessed using the Quigley-Hein Plaque Index at the full-mouth level and separately for the incisor, canine, premolar, and molar regions. Scores were recorded at baseline and at the end of the first week. Lower scores indicate lower plaque accumulation. |
From enrollment to the end of treatment at 1 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Gingival Index
Tidsramme: From enrollment to the end of treatment at 1 week
|
Gingival health was assessed using the Gingival Index at the full-mouth level. Scores were recorded at baseline and at the end of the first week. Lower scores indicate better gingival health. |
From enrollment to the end of treatment at 1 week
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023/27
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