A Comparative Study of Electric Toothbrushes for the Efficacy Plaque

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03416985
Study type	Interventional
Source	University of California, Los Angeles
Contact
Status	Completed
Phase	N/A
Start date	January 2, 2018
Completion date	December 30, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04881357` - Antiplaque/Antigingivitis Effect of Lacer Oros Integral	N/A
Completed	`NCT04561960` - Efficacy of Miswak in Oral Hygiene Maintenance	Phase 4
Completed	`NCT04025684` - Efficacy of Manual Toothbrushes in Removing Dental Plaque	N/A
Completed	`NCT03394729` - Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes	Phase 2/Phase 3
Completed	`NCT05187507` - Effectiveness of Theobromine Toothpaste	N/A
Completed	`NCT04485520` - Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans	N/A
Completed	`NCT02884817` - Essential Oil+ELA, Plaque and Gingivitis	Phase 4
Completed	`NCT02552589` - Effect of Toothpaste on the Reduction of Plaque and Inflammation	N/A
Completed	`NCT02194023` - Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.	Phase 2
Completed	`NCT01237782` - Efficacy of a Propolis-based Denture Cleanser	N/A
Completed	`NCT00758394` - Clinical Study to Compare Dental Plaque Control	Phase 3
Completed	`NCT00254345` - Effect of Provisional-Crown Surface Coating on Biofilm Formation	Phase 1
Completed	`NCT05579938` - Effect of Enzymes on Dental Biofilm Accumulation	N/A
Completed	`NCT05038293` - Efficacy of Plaque Removal of a Novel Brushing Device	N/A
Terminated	`NCT05082103` - Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals	N/A
Not yet recruiting	`NCT06081868` - RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda	N/A
Completed	`NCT05853679` - Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents	N/A
Completed	`NCT05521230` - Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software	Phase 1
Completed	`NCT03311438` - Oral Health Intervention Program for Children With Congenital Heart Defects	N/A
Enrolling by invitation	`NCT06122636` - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms