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The Effect of Using Plaque-disclosing Tablets on the Effectiveness of Toothbrushing and Gingival Health in Children

3. november 2026 opdateret af: Ezgi Sila Taskaldiran

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

53

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

10 år til 14 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Quigley-Hein Plaque Index
Tidsramme: From enrollment to the end of treatment at 1 week

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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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)

29. april 2025

Primær færdiggørelse (Faktiske)

17. juli 2026

Studieafslutning (Faktiske)

21. august 2026

Datoer for studieregistrering

Først indsendt

3. november 2026

Først indsendt, der opfyldte QC-kriterier

3. november 2026

Først opslået (Faktiske)

9. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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