A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health in Partial Denture Wearers

NCT04290624 | Completed Phase 4 Results

• 1 other identifier: 212401
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Mean Bleeding Index (BI) at 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.

  Week 12

Secondary Outcomes (9)

• Mean Number of Bleeding Sites (NBS) 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 Overall Turesky Plaque Index (TPI) 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 BI at Week 6

  Week 6

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will be instructed to use a dentifrice containing 0.454 percent (%) weight by weight (w/w) Stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 parts per million (ppm) sodium fluoride. Participants will brush with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto removable partial denture (RPD) for 90 seconds and 10 milliliter (ml) of mouth rinse for swished around the mouth for 1 minute. Participants will apply all these products twice daily (morning and evening) for 12 weeks.

Other: Experimental Dentifrice: Stannous Fluoride; Device: COREGA Denture Foaming Cleanser; Other: Mouth rinse: Sodium Fluoride

Reference Group

NO INTERVENTION

Participants will not be supplied any products and will continue with their existing dental/denture hygiene practices and should not make changes to either their established habits nor to the products they use following screening.

Interventions

Experimental Dentifrice: Stannous Fluoride OTHER

Participants will be instructed to dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion containing 0.454% w/w Stannous fluoride for 2 minutes twice daily (morning and evening) for 12 weeks.

Intervention Group

COREGA Denture Foaming Cleanser DEVICE

Participant will clean their denture using 2 pumps of the denture cleansing foam and a denture cleaning brush for 90 timed seconds outside of the mouth twice daily (morning and evening) for 12 weeks.

Intervention Group

Mouth rinse: Sodium Fluoride OTHER

Participants will take 10 ml of the mouth rinse containing 90 ppm sodium fluoride and swished around the mouth for 1 minute twice daily (morning and evening) for 12 weeks.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• A participant who, in the opinion of the investigator, should not participate in the study.
• A participant who has taken or is currently taking antibiotics at the Screening visit or in the 14-day period prior to the Baseline visit or requiring antibiotic use prior to dental prophylaxis or other dental procedure.
• A participant who is currently taking, on a regular daily basis, an anti-inflammatory, anticoagulant or any other systemic medication (e.g. calcium channel blockers, aspirin therapy, ibuprofen, warfarin) or has a medical condition which, in the opinion of the Investigator, could affect the gingival condition.
• A participant who has used an antibacterial mouth rinse (e.g. chlorhexidine, Listerine), dentifrice (e.g. stannous fluoride) or use of any oral care product that, in the opinion of the investigator, could interfere with plaque accumulation or clinical measures within 28 days preceding the baseline visit.
• A participant with a condition or who is taking medication which, in the opinion of the investigator is causing xerostomia.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

GSK Investigational Site

Bristol, BS1 2LY, United Kingdom

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+44 7880 182593

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: October 14, 2020
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

GB (1)