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Completed

NCT Number: NCT02534220

Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual toothbrush

Device

Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH

Oscillating-rotating toothbrush

Device

Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH

Primary outcomes

  1. Change in Complete Root Coverage Rate

    Time frame: Change in Complete Root Coverage Rate at 1 month

    Abscence of exposed root surface measured ad percentage

  2. Change in Complete Root Coverage Rate

    Time frame: Change in Complete Root Coverage Rate at 3 months

    Abscence of exposed root surface measured ad percentage

  3. Change in Complete Root Coverage Rate

    Time frame: Change in Complete Root Coverage Rate at 6 months

    Abscence of exposed root surface measured ad percentage

Secondary outcomes

  1. Change in Recession Depth

    Time frame: Baseline, 1 month, 3 months, 6 months

    Distance from the gingival margin to the cementum-enamel junction, measured in millimeters

  2. Change in Clinical Attachment Level

    Time frame: Baseline, 1 month, 3 months, 6 months

    Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters

  3. Change in Probing Pocket Depth

    Time frame: Baseline, 1 month, 3 months, 6 months

    Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2015
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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