A Randomized, Controlled Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health, Compared to Existing Oral Hygiene, in a Population of Partial Denture Wearers With Generalized Mild-moderate Plaque-induced Gingivitis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Gingivitis
- Sponsor
- HALEON
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Mean Bleeding Index (BI) at Week 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to investigate the effectiveness of usage of a range of oral products (toothpaste, mouth rinse, denture cleanser) on the oral health of partial denture wearers compared to existing oral hygiene habits.The hypothesis is that there is no treatment difference in the oral health when using the range of products for 12 weeks compared to no intervention.
Detailed Description
This study is a single-center, single-blind (to the examiner(s) performing the plaque, gingivitis, denture cleanliness and oral hygiene assessments), randomized, stratified (by denture material type and baseline mean overall modified gingival index \[MGI\] score), two-treatment, parallel group, 12 week clinical study in generally healthy, adult participants with at least one conventional removable partial denture (RPD) and generalized, mild-moderate, plaque-induced gingivitis (as determined by clinical examiner) and greater than or equal to \>=4 natural teeth in each arch that meet all study criteria at both the Screening and Baseline visits (including \>= 30 evaluable surfaces for clinical evaluation of gingivitis and plaque). The study will examine the effects of twice daily use of a range of dental/denture products (comprising use of a dentifrice, a mouthrinse and a denture cleanser) compared to no intervention (participants who continue with their existing oral hygiene habits). There will be four visits to the study site: screening, baseline (when participants are randomized), and after 6- and 12 weeks use of the range of dental/denture products.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- •A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- •A participant with good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant or relevant abnormalities in medical history or upon oral examination, or a condition, that would impact the participant's safety, well being or the outcome of the study, if they were to participate in the study.
- •A participant who is a cell phone owner with text messaging capabilities.
- •Dental Criteria:
- •A participant with a minimum of 4 natural teeth in each arch.
- •A participant with a minimum of 30 scorable surfaces for MGI (Modified Gingival Index), BI (Bleeding Index), OHI (oral hygiene index) and TPI (Turesky Plaque Index). (A scorable surface is defined as a surface that has at least 2/3 of the surface gradable for each clinical index. Third molars, orthodontically banded/bonded, fully crowned or extensively restored or grossly carious teeth are not included in the tooth or scorable surface count. Third molars can be included if, as a result tooth loss, they are functioning as second molars. Tooth surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the assessments of the selected clinical indices are also excluded.)
- •A participant with a minimum of 2 scorable abutment teeth, defined as teeth proximal to the RPD (removable partial denture) or impinged by an RPD clasp or rest.
- •A participant with generalized mild-moderate plaque-induced gingivitis present at the screening visit (in the opinion of the clinical examiner from a gross visual examination).
- •A participant with a mean whole mouth BI \>= (greater than or equal to) 0.1 to =\< (less than or equal to) 1.3, a mean whole mouth MGI \>= 1.75 to =\< 2.30 and a mean overall TPI score \> (greater than) 1.5 at the Baseline visit.
Exclusion Criteria
- •A Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH (GlaxoSmithKline Consumer Healthcare) employee directly involved in the conduct of the study or a member of their immediate family.
- •A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •A participant with an acute or chronic medical or psychiatric condition 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 participant inappropriate for entry into this study.
- •A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
- •A participant who is breastfeeding.
- •A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •A participant who smokes (defined as having smoked or used nicotine products (including ecigarettes, chewing tobacco, gutkha, pan- containing tobacco, nicotine replacement therapies) during the previous 12 months).
- •A participant who is unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
- •A participant with a recent history (within the last year) of alcohol or other substance (e.g. illicit drug) abuse.
- •A participant who has previously been enrolled in this study.
Outcomes
Primary Outcomes
Mean Bleeding Index (BI) at Week 12
Time Frame: Week 12
The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted into the gingival crevice to a depth of approximately 1 millimeter \[mm\] and then run around the tooth (at approximately 60 degrees to the long axis of the tooth) gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Three scores were recorded bucally/labially (distal, body, mesial sites) and 3 scores lingually/palatally (distal, body, mesial sites). All scorable teeth in 1 quadrant were probed first (approximately 30 seconds) before recording the number of gingival units which bled. The BI scoring included 3-point scale ranged from 0 to 2, where 0=no bleeding, 1=bleeding within 30 seconds of probing, 2=bleeding immediately on probing. Sites with a score of 1 or 2 were classified as 'bleeding' sites. Higher score indicates worst outcome.
Secondary Outcomes
- Mean Number of Bleeding Sites (NBS) at Week 6 and Week 12(Week 6 and Week 12)
- Mean Overall Turesky Plaque Index (TPI) at Week 6 and Week 12(Week 6 and Week 12)
- Mean BI at Week 6(Week 6)
- Mean Oral Debris Index (ODI) at Week 6 and Week 12(Week 6 and Week 12)
- Mean Interproximal TPI at Week 6 and Week 12(Week 6 and Week 12)
- Mean Modified Gingival Index (MGI) at Week 6 and Week 12(Week 6 and Week 12)
- Mean Oral Hygiene Index (OHI) at Week 6 and Week 12(Week 6 and Week 12)
- Mean Partial Denture Cleanliness Index (PDCI) at Week 6 and 12(Week 6 and Week 12)
- Mean Calculus Index (CI) at Week 6 and Week 12(Week 6 and Week 12)