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A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Dental Plaque
Dental Plaque Induced Gingivitis

Treatments

Device: BURST Sonic Oral Care
Device: Oral B Healthy Clean Manual Toothbrush
Device: Philipps Sonicare DiamondClean 300 Series

Study type

Interventional

Funder types

Other

Identifiers

NCT03416985
17-001622

Details and patient eligibility

About

It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.

Full description

The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made.

Study design: randomised, single blinded, parallel.

After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0.

The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations.

At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush.

The subjects will be instructed to brush twice a day for a period of 2 minutes (following the programmed toothbrush timer) and refrain from using dental floss, tooth pick or any mechanical oral hygiene aid for the period of the study.

On the second visit at 14 days (T2) and third visit at 30 days (T3), additional GI and PI readings will be taken and data will be recorded. All measurements and clinical examinations will be performed by a single blinded examiner. Evaluation on teeth will be made on six teeth #3,7,12,19,23 and 28 (mesio-buccal, buccal, disto-buccal and mesio-lingual, lingual, disto-lingual) following the Silness-Loe Index.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Good overall health
  2. At least 20 teeth present, not including 3rd Molars
  3. Non-smoker

Exclusion criteria

  1. Poor manual dexterity or mentally handicap;
  2. Presence of removable intra-oral prosthesis
  3. Current orthodontic therapy
  4. Severe Periodontal condition or caries teeth in need of immediate attention
  5. Pregnant women
  6. Subjects that use medications that may effect oral health
  7. No Systemic diseases/conditions such as diabetes mellitus, heart disease.
  8. Use of plaque inhibiting toothpaste, mouthwash, interdental flossing in the period of the study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups

Manual Toothbrush
Active Comparator group
Description:
Patients will be asked to use a manual toothbrush for 30 days
Treatment:
Device: Oral B Healthy Clean Manual Toothbrush
Sonic Toothbrush
Active Comparator group
Description:
Patients will be asked to use a sonic toothbrush for 30 days
Treatment:
Device: BURST Sonic Oral Care
Pulsating Toothbrush
Active Comparator group
Description:
Patients will be asked to use a pulsating toothbrush for 30 days
Treatment:
Device: Philipps Sonicare DiamondClean 300 Series

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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