- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02534220
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
MI
-
Milan, MI, Italien, 20122
- Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Manual Toothbrush
Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.
|
Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH
|
|
Experimentell: Oscillating-rotating toothbrush
Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.
|
Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Complete Root Coverage Rate
Tidsram: Change in Complete Root Coverage Rate at 1 month
|
Abscence of exposed root surface measured ad percentage
|
Change in Complete Root Coverage Rate at 1 month
|
|
Change in Complete Root Coverage Rate
Tidsram: Change in Complete Root Coverage Rate at 3 months
|
Abscence of exposed root surface measured ad percentage
|
Change in Complete Root Coverage Rate at 3 months
|
|
Change in Complete Root Coverage Rate
Tidsram: Change in Complete Root Coverage Rate at 6 months
|
Abscence of exposed root surface measured ad percentage
|
Change in Complete Root Coverage Rate at 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Recession Depth
Tidsram: Baseline, 1 month, 3 months, 6 months
|
Distance from the gingival margin to the cementum-enamel junction, measured in millimeters
|
Baseline, 1 month, 3 months, 6 months
|
|
Change in Clinical Attachment Level
Tidsram: Baseline, 1 month, 3 months, 6 months
|
Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters
|
Baseline, 1 month, 3 months, 6 months
|
|
Change in Probing Pocket Depth
Tidsram: Baseline, 1 month, 3 months, 6 months
|
Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters
|
Baseline, 1 month, 3 months, 6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Giulio Rasperini, Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Oral-B
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