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Completed

NCT Number: NCT03158350

Toothbrush Wear and Its Effect on Subgingival Inflammation Using Two Different Brushing Techniques

Toothbrush plaque removal, along with interproximal flossing, helps to maintain the oral cavity free from periodontal diseases and dental caries. Although techniques such as the Bass Technique (BT), the Modified Bass Technique (MBT) and the Modified Stillman Technique (MST) are taught to dental students, dental hygiene students, and dental assistants, there is little evidence to discern which technique is more effective in reducing or preventing gingival inflammation.

At Tufts University School of Dental Medicine (TUSDM), a modification of the Bass intrasulcular technique is advocated to many students. We call this modification of the Bass technique a Stationary Bristle Technique (SBT), which is an intrasulcular technique that maintains the toothbrush bristle ends essentially stationary on the tooth cervically and in the gingival crevice.

In this study, half of the participants were taught the Stationary Bristle Technique Group, while the other half were not be provided with instructions, but asked to brush as normal (non-interventional group) throughout the duration of the study.

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Key information

Conditions

Gingival Inflammation Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

About this study

This is a double-armed, randomized clinical trial. The primary aim of this study is to compare whether a Stationary Brushing Technique (SBT) is more effective in the reduction of gingival inflammation than permitting people to brush the way they normally do without instruction (Non-Stationary Brushing Technique).

Gingival inflammation is evidenced by the percentage (%) sites with Bleeding on Probing (BoP). The primary time-point will be at 4 weeks.

The amount of toothbrush bristle deformation at 4 weeks, 12, and 16 weeks of brushing with a SBT and with a NSBT will also be evaluated. 3. The secondary evaluation of BoP will be at the 12 and 16 week time-point.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must be at least 18 years of age
  • Subjects must have at least 20 teeth
  • Subjects must have had a professional dental prophylaxis done in the 3 months prior to the beginning of the study
  • Subjects exhibiting 10% or greater BoP at the baseline examination

Exclusion criteria

  • Subjects wearing fixed orthodontic appliances (including lingual retainers or Invisalign®)
  • Subjects who smoke (=more than 0 cigarettes a day)
  • Subjects who received antibiotic treatment during the month prior to the beginning of the study
  • Subjects who have cervical probing depth (PD) greater than 3mm
  • Subjects diagnosed with periodontal disease at any site as defined bleeding on probing with cervical probing depths greater than 3 mm and loss of cervical attachment.
  • Subjects who are currently pregnant (self-report).

Treatment and study plan

Instructed Brushing Method

Other

Stationary Bristle Technique

Primary outcomes

  1. Change in Gingival Inflammation

    Time frame: From Baseline up to 4 weeks

    Measured by the percentage of sites with BoP. The percentage of sites with BoP at each time point will be calculated by group

Secondary outcomes

  1. Toothbrush Bristle Deformation

    Time frame: From baseling up to 16 weeks

    Toothbrush bristle deformation will be measured at 4 weeks, 12 weeks, and 16 weeks of brushing with SBT or NSBT. The mean and standard deviation of the deformation measurements (length and width) will be calculated at each time point for each group.

  2. Change in BoP

    Time frame: From baseline up to 16 weeks

    The secondary evaluation of BoP will be at the 12 and 16 week time-point.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

A Tooth Brushing Technique That Reduces Gingival Inflammation and Toothbrush Deformation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 18, 2017
Registry last updated
Mar 12, 2019

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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