Effect of a Multi-directional Power Toothbrush on Recession

• Sponsor: University Hospital Schleswig-Holstein (Other)
• Overall Status: Completed
• CT.gov ID: NCT02530671
• Collaborator: Procter and Gamble (Industry)
• Enrollment: 110
• Arms: 2

Study Details

Study Description

Brief Summary

Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months

Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession	Device: Toothbrushing with manual toothbrush; Device: Toothbrushing with power toothbrush	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of a Multi-directional Power and a Manual Toothbrush in Subjects Susceptible to Gingival Recession: A 12-month Randomized Controlled Clinical Study
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Manual toothbrush ADA reference manual toothbrush	Device: Toothbrushing with manual toothbrush
Experimental: Power toothbrush Multi-directional power toothbrush	Device: Toothbrushing with power toothbrush

Outcome Measures

Primary Outcome Measures

1. Gingival Recession at Sites With Preexisting Recessions ≥2mm [12 months]

2. Bristle Splay Index (BSI) After a Specific Time-of-use [3, 6, 9 and 12 months]

   A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).

Secondary Outcome Measures

1. Recession at All Buccal Sites [12 months]

2. Percentage of Recession Sites Demonstrating a Change of ≥1mm [12 months]

3. Pocket Probing Depths at 12months [12 months]

4. Comparison of BSI Between Periods [0-3, 9-12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 scorable teeth without orthodontic appliances or crowns and bridges

• at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth)

Exclusion Criteria:

• evidence of neglected dental health

• periodontitis and/or major hard/soft tissue lesions

• any physical limitations or restrictions potentially interfering with normal oral hygiene

• therapy with any drug within 28 days prior to the study

• pregnancy or breast feeding

• any systematic condition or significant illness

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital Schleswig-Holstein
• Procter and Gamble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sonja Sälzer, Dr. Sonja Sälzer, University Hospital Schleswig-Holstein
• ClinicalTrials.gov Identifier: NCT02530671
• Other Study ID Numbers: 2011015
• First Posted: Aug 21, 2015
• Last Update Posted: Apr 27, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Sonja Sälzer, Dr. Sonja Sälzer, University Hospital Schleswig-Holstein: multi-directional power toothbrush; manual toothbrush
• Additional relevant MeSH terms: Gingival Recession

Study Results

Participant Flow

Arm/Group Title	Manual Toothbrush	Power Toothbrush
Arm/Group Description	ADA (American Dental Association) reference manual toothbrush Toothbrushing with manual toothbrush	Multi-directional power toothbrush Toothbrushing with power toothbrush
Period Title: Overall Study
STARTED	55	55
COMPLETED	52	55
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Manual Toothbrush	Power Toothbrush	Total
Arm/Group Description	ADA reference manual toothbrush Toothbrushing with manual toothbrush	Multi-directional power toothbrush Toothbrushing with power toothbrush	Total of all reporting groups
Overall Participants	55	55	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30 (9.7)	32 (12.5)	31 (11.2)
Sex: Female, Male (Count of Participants)
Female	32 58.2%	31 56.4%	63 57.3%
Male	23 41.8%	24 43.6%	47 42.7%
Region of Enrollment (participants) [Number]
Germany	55 100%	55 100%	110 100%
Smoker (Yes/Now) (participants) [Number]
Yes	7 12.7%	7 12.7%	14 12.7%
No	48 87.3%	48 87.3%	96 87.3%
Previous used toothbrush (MT/PT) (participants) [Number]
Manual Toothbrush	40 72.7%	27 49.1%	67 60.9%
Power Toothbrush	15 27.3%	28 50.9%	43 39.1%

Outcome Measures

1. Primary Outcome

Title	Gingival Recession at Sites With Preexisting Recessions ≥2mm
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Toothbrush	Power Toothbrush
Arm/Group Description	ADA reference manual toothbrush Toothbrushing with manual toothbrush	Multi-directional power toothbrush Toothbrushing with power toothbrush
Measure Participants	55	55
Mean (Standard Deviation) [mm]	2.09 (0.29)	2.08 (0.30)

2. Secondary Outcome

Title	Recession at All Buccal Sites
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Toothbrush	Power Toothbrush
Arm/Group Description	ADA reference manual toothbrush Toothbrushing with manual toothbrush	Multi-directional power toothbrush Toothbrushing with power toothbrush
Measure Participants	55	55
Mean (Standard Deviation) [mm]	0.416 (0.18)	0.007 (0.16)

3. Secondary Outcome

Title	Percentage of Recession Sites Demonstrating a Change of ≥1mm
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Toothbrush	Power Toothbrush
Arm/Group Description	ADA reference manual toothbrush Toothbrushing with manual toothbrush	Multi-directional power toothbrush Toothbrushing with power toothbrush
Measure Participants	55	55
decrease	14	24
increase	9	5

4. Secondary Outcome

Title	Pocket Probing Depths at 12months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Toothbrush	Power Toothbrush
Arm/Group Description	ADA reference manual toothbrush Toothbrushing with manual toothbrush	Multi-directional power toothbrush Toothbrushing with power toothbrush
Measure Participants	55	55
Mean (Standard Deviation) [mm]	1.91 (0.17)	1.88 (0.18)

5. Primary Outcome

Title	Bristle Splay Index (BSI) After a Specific Time-of-use
Description	A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).
Time Frame	3, 6, 9 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Toothbrush	Power Toothbrush
Arm/Group Description	ADA reference manual toothbrush Toothbrushing with manual toothbrush	Multi-directional power toothbrush Toothbrushing with power toothbrush
Measure Participants	55	54
Mean (Standard Deviation) [percentage of the original bristle field]	0.2 (0.2)	0.1 (0.1)

6. Secondary Outcome

Title	Comparison of BSI Between Periods
Time Frame	0-3, 9-12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Toothbrush	Power Toothbrush
Arm/Group Description	ADA reference manual toothbrush Toothbrushing with manual toothbrush	Multi-directional power toothbrush Toothbrushing with power toothbrush
Measure Participants	54	55
0-3 months	23.6 (14)	6.4 (11)
9-12months	28.0 (14.8)	9.8 (12.1)

Adverse Events

Arm/Group Title	Manual Toothbrush		Power Toothbrush
Arm/Group Description	ADA reference manual toothbrush Toothbrushing with manual toothbrush		Multi-directional power toothbrush Toothbrushing with power toothbrush
All Cause Mortality
	Manual Toothbrush		Power Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Manual Toothbrush		Power Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Manual Toothbrush		Power Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.