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Completed

NCT Number: NCT02530671

Effect of a Multi-directional Power Toothbrush on Recession

Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months

Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 scorable teeth without orthodontic appliances or crowns and bridges
  • at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth)

Exclusion criteria

  • evidence of neglected dental health
  • periodontitis and/or major hard/soft tissue lesions
  • any physical limitations or restrictions potentially interfering with normal oral hygiene
  • therapy with any drug within 28 days prior to the study
  • pregnancy or breast feeding
  • any systematic condition or significant illness

Treatment and study plan

Toothbrushing with manual toothbrush

Device

Toothbrushing with power toothbrush

Device

Primary outcomes

  1. Gingival Recession at Sites With Preexisting Recessions ≥2mm

    Time frame: 12 months

  2. Bristle Splay Index (BSI) After a Specific Time-of-use

    Time frame: 3, 6, 9 and 12 months

    A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).

Secondary outcomes

  1. Recession at All Buccal Sites

    Time frame: 12 months

  2. Percentage of Recession Sites Demonstrating a Change of ≥1mm

    Time frame: 12 months

  3. Pocket Probing Depths at 12months

    Time frame: 12 months

  4. Comparison of BSI Between Periods

    Time frame: 0-3, 9-12 months

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • Procter and Gamble

Registry information

Official study title

Effect of a Multi-directional Power and a Manual Toothbrush in Subjects Susceptible to Gingival Recession: A 12-month Randomized Controlled Clinical Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Aug 21, 2015
Registry last updated
Jan 1, 2025

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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