A Study to Determine the Effects of Adding an Experimental Device With Mouthrinse to Oral Care Regimen

NCT01419626 | Completed Results FDA Device

• 1 other identifier: UNKPLT0008
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The study will determine the effects of adding mechanical plaque control to a person's oral care regimen. Participants who qualify to participate in the study will will have an equal chance of being assigned to one of three groups. They will be asked to follow their assigned oral care regimen, fill out subject diaries as instructed, and return to the clinic two weeks and four weeks afterward to have their mouths examined.

Conditions

Gingivitis

Keywords

Dental Plaque; Interdental Cleaning Device

Outcome Measures

Primary Outcomes (2)

• Interproximal Mean Plaque Index at Week 4

  Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 millimeter \[mm\]), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.

  Week 4

• Whole-mouth Mean Plaque Index at Week 4

  Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.

  Week 4

Secondary Outcomes (6)

• Interproximal Mean Modified Gingival Index (Mean MGI) at Week 2 and 4

  Week 2 and 4

• Whole-mouth Modified Gingival Index (Mean MGI) at Week 2 and 4

  Week 2 and 4

• Interproximal Mean Plaque Index (Mean PI) at Week 2

  Week 2

• Whole-mouth Mean Plaque Index (Mean PI) at Week 2

  Week 2

• Interproximal Mean Bleeding Index (Mean BI) at Week 2 and 4

  Week 2 and 4

Study Arms (3)

Negative Control

NO INTERVENTION

Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste.

Device with Water

SHAM COMPARATOR

Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.

Device: Interdental cleaning device with water

Device with Mouthrinse

EXPERIMENTAL

Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.

Device: Interdental cleaning device with essential-oil mouthrinse

Interventions

Interdental cleaning device with water DEVICE

Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.

Also known as: Regulation # 872.6510 with water

Device with Water

Interdental cleaning device with essential-oil mouthrinse DEVICE

Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.

Also known as: Regulation # 872.6510 with Mouthrinse # 19292-116A

Device with Mouthrinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment.
• Able to provide written informed consent; volunteers must read, sign, and receive a copy of the signed Informed Consent Form after the nature of the study has been fully explained.
• Males and females 18 years of age or older, in good general and oral health, except gingivitis.
• A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
• A gingival index ≥ 1.75 according to the Modified Gingival Index.
• A plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
• Gingival Bleeding Index ≥ 0.1.
• Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator.
• Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
• Absence of fixed or removable orthodontic appliance or removable partial dentures.
• Are willing and able to fully understand and comply with the written and verbal study instructions provided in English
• Agree to return all study materials at the final visit (week 4).

You may not qualify if:

• History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye.
• History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject, such as having have a cardiac pacemaker or AICD.
• History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
• Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam.
• Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline.
• Current or history of alcohol or drug abuse, and those who smoke more than one pack of cigarettes per day
• Females who are pregnant or breastfeeding.
• Known sensitivity to the investigational product.
• Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study.
• Participation in any clinical study within 30 days of Visit 1.
• Relative, partner or staff of any clinical research site personnel.
• A member of the same household (i.e. residing in the same house) is a participant in this study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Are employed by an oral healthcare products company or dental research institution (i.e., dental school: administrative staff, assistants, hygienists, and research students).

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

BioSci Research America, Inc

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Limitations and Caveats

No study limitation was reported.

Results Point of Contact

• Title: DIRECTOR ORAL HEALTH, MEDICAL AFFAIR & CLINICAL RESEARCH
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Marcelo WB Araujo, DDS,MS,PhD

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 18, 2011
• Study Start: July 31, 2011
• Primary Completion: August 31, 2011
• Study Completion: August 31, 2011
• Last Updated: December 17, 2019
• Results First Posted: December 17, 2019

Record last verified: 2019-11

Locations

US (1)