Clinical trial NCT03416985: A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
Official title: A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque Induced Gingivitis
Dental Plaque
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque Index
timeFrame: Baseline, 1 month
measure: Gingival Index
timeFrame: Baseline, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Dentistry
state: California
Study officials:
References: