Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure
Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
METHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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MI
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Milan, MI, Italië, 20122
- Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Full-Mouth Plaque Score (FMPS) ≤25%
- Full-Mouth Bleeding Score (FMBS) ≤25%
- Miller Class I and II buccal recession ≥2 mm
Exclusion Criteria:
- Relevant systemic condition or disease
- Smokers
- Teeth with prosthetic crowns or restorations in the cervical area
- Presence of pulling frenum in the keratinized tissue
- Previous mucogingival or periodontal surgery in the experimental site
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Manual Toothbrush
Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.
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Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH
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Experimenteel: Oscillating-rotating toothbrush
Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.
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Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Complete Root Coverage Rate
Tijdsspanne: Change in Complete Root Coverage Rate at 1 month
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 1 month
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Change in Complete Root Coverage Rate
Tijdsspanne: Change in Complete Root Coverage Rate at 3 months
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 3 months
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Change in Complete Root Coverage Rate
Tijdsspanne: Change in Complete Root Coverage Rate at 6 months
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Recession Depth
Tijdsspanne: Baseline, 1 month, 3 months, 6 months
|
Distance from the gingival margin to the cementum-enamel junction, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
|
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Change in Clinical Attachment Level
Tijdsspanne: Baseline, 1 month, 3 months, 6 months
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Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
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Change in Probing Pocket Depth
Tijdsspanne: Baseline, 1 month, 3 months, 6 months
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Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Giulio Rasperini, Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Oral-B
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