Phase 4
N=49
A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health in Partial Denture Wearers
Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT04290624 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Mean Bleeding Index (BI) at Week 12 — 0.45; 0.76 Score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Experimental Dentifrice: Stannous Fluoride (Other); COREGA Denture Foaming Cleanser (Device); Mouth rinse: Sodium Fluoride (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Bleeding Index (BI) at Week 12 |
0.45; 0.76 | <0.0001 sig |
| SECONDARY Mean Number of Bleeding Sites (NBS) at Week 6 and Week 12 |
53.1; 81.7; 52.9; 80.8 | <0.0001 sig |
| SECONDARY Mean Modified Gingival Index (MGI) at Week 6 and Week 12 |
1.52; 1.92; 1.50; 1.86 | <0.0001 sig |
| SECONDARY Mean Overall Turesky Plaque Index (TPI) at Week 6 and Week 12 |
2.12; 2.97; 2.07; 3.02 | <0.0001 sig |
| SECONDARY Mean Interproximal TPI at Week 6 and Week 12 |
2.31; 3.22; 2.24; 3.29 | <0.0001 sig |
| SECONDARY Mean BI at Week 6 |
0.45; 0.76 | <0.0001 sig |
| SECONDARY Mean Partial Denture Cleanliness Index (PDCI) at Week 6 and 12 |
1.2; 1.7; 1.1; 1.9 | 0.0039 sig |
| SECONDARY Mean Calculus Index (CI) at Week 6 and Week 12 |
0.08; 0.19; 0.10; 0.18 | 0.0367 sig |
| SECONDARY Mean Oral Debris Index (ODI) at Week 6 and Week 12 |
0.22; 0.50; 0.20; 0.46 | 0.0006 sig |
| SECONDARY Mean Oral Hygiene Index (OHI) at Week 6 and Week 12 |
0.30; 0.69; 0.30; 0.64 | 0.0020 sig |
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.
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 = = 1.75 to = (greater than) 1.5 at the Baseline visit.
- A participant who habitually wears one conventional removable partial denture constructed of acrylic or cobalt chrome which is acceptable according to the well made and well-fit assessments.
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 b
Data sourced from ClinicalTrials.gov (NCT04290624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.