Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession

Gingival Recession Clinical Trial

Official title:

A Pilot Randomized Clinical Trial of a Manual Bristle-less Tooth Brush Demonstrates Slight Improvement in Gingival Recession Compared to a Conventional Soft Manual Brush

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951065
• Other study ID #: WUCDM 1 2016
• Status: Completed
• Phase: N/A
• First received: October 27, 2016
• Last updated: May 8, 2017
• Start date: March 2015
• Est. completion date: April 10, 2017

Study information

• Verified date: May 2017
• Source: Western University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush.

Subjects are recruited from patients attending the Western University of Health Sciences Dental Center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. The exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.

Description:

Purpose: This randomized clinical trial tested if a novel bristle-less tooth brush design is more effective in preventing gingival recession in adults receiving periodontal maintenance than a soft tooth brush with nylon bristles.

Materials and methods: The investigators will recruit 23 subjects with gingival recession who received regular periodontal maintenance care at Western University of Health Sciences Dental Center, and who did not exhibit signs of acute dental and systemic disease, occlusal discrepancies and parafunctional habits. The investigators will randomly assign these subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group using the experimental tooth brush that contains a brush head with short, soft, rubbery cones. Both groups will receive regular maintenance and periodontal exams by blinded examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and gingival recession. In addition, gingival recession will also be determined using a measuring guide on study models obtained with polyvinylsiloxane impressions. For added control of confounding variables, both groups will be supplied with abrasivity tooth paste and waxed floss while receiving repeated oral hygiene instruction and phone follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 10, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• receive regular periodontal treatment at the Western University of Health Sciences Dental Center

• have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths

Exclusion Criteria:

• unable to provide consent

• had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3

• acute pain or infection

• caries near the gingival margin

• restorations covering the gingival recession defect

• presence of Miller Class III or IV defects

• severe or aggressive periodontitis

• missing more than one anterior tooth

• severe malocclusion

• presence of occlusal trauma requiring more than limited adjustment

• Tobacco use

• ongoing or planned orthodontic therapy

• oral piercings

• history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits

• preferred use of an electric tooth brush over a manual brush

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Other:
• Tooth brush without nylon bristles
Subjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
• Tooth brush with soft nylon bristles
Subjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Western University of Health Sciences	Peri-Swab, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)	Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.	About 1 year
Secondary	Plaque level	Oral plaque level as recorded using the Quigley-Hein index as modified by Turesky	About 1 year
Secondary	Gingival bleeding on probing	% bleeding sites on probing (6 sites per tooth). Gingival bleeding is a measure of gingival inflammation, which needs to stay minimal no matter what tooth brush is used.	About 1 year
Secondary	Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)	This is another measure of periodontal inflammation and sign of gum disease, as well as effectiveness of brush in preventing plaque buildup and development of periodontal disease.	About 1 year