A Randomized, Single-blind, Efficacy Study to Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive
Overview
- Phase
- Phase 3
- Intervention
- Experimental Denture Adhesive
- Conditions
- Denture Retention
- Sponsor
- GlaxoSmithKline
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 12 Weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of this study is to evaluate the use of a denture adhesive and its ability to demonstrate the improvement in overall gum-health and to improve the oral health related quality of life (OHrQoL) in participants who wear full dentures.
Detailed Description
This study will be a single center, controlled, single-blind, randomized, two-treatment, parallel design in healthy participants with a full conventional, acrylic denture in either or both dental arches, with a treatment period of 12 weeks. The study will assess the effectiveness of an experimental denture adhesive in the improvement of denture-bearing tissue irritation related measures, and the participant's oral health related quality of life. Participants will be randomized to one of the 2 treatment groups i.e. experimental denture arm group and control arm group and will undergo an oral soft tissue (OST) examination. Participants with satisfactory dentures, adequate retention and stability and who qualify all the inclusion and exclusion criteria will continue in the study. Participants will complete the Gum Comfort, OHIP-Edent questionnaires and GOHAI questionnaire. The assessments will be made at Baseline, and after 1, 4, 8 and 12 weeks treatment.
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 in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- •Pregnant women: must agree to use a highly effective method of contraception throughout the study and for 5 days after the last dose of assigned treatment.
- •Participant has denture prostheses that fulfill all of the following:
- •A conventional acrylic full denture in either or both of the upper and lower arches. The full denture may be opposed by a partial denture, natural teeth or another full denture.
- •Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥ 3 for each denture \[maxillary and/or mandibular\] with no individual stability or retention scores \<
- •c Denture(s) are well made (according to the well-made assessment).
- •Participant is a habitual wearer of their denture(s) defined as participants who wear their dentures for the majority of their time whilst awake.
- •Participant has worn their full denture(s) for at least a year.
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 GlaxoSmithKline Consumer Healthcare (GSKCH) 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, in the opinion of the investigator or medically qualified designee, an 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 or medically qualified designee, would make the participant inappropriate for entry into this study.
- •A participant who is a pregnant female.
- •A participant who is a breastfeeding female.
- •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, in the opinion of the investigator or medically qualified designee, should not participate in the study.
- •A participant unwilling or unable to comply with the Lifestyle Considerations:
- •Participants will not be permitted to have any dental/denture work performed during the time they are in the study, unless discussed and permitted by the examiner. This is to ensure that the denture fit will not be altered during the study.
- •Participants will not be able to use any denture adhesive product other than that supplied by the investigator.
Arms & Interventions
Experimental denture adhesive
In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.
Intervention: Experimental Denture Adhesive
Outcomes
Primary Outcomes
Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 12 Weeks
Time Frame: At Baseline and after 12 weeks
Gum comfort questionnaire was referred to assess the gum health of the denture wearer and to compare the ability of an experimental denture adhesive to provide self-perceived mucosal benefits compared to the use of no adhesive after 12 weeks of product use. It was comprised of 5 questions- Q1: My gums feel comfortable when wearing my denture(s), Q2: I feel my gums are cushioned from the impact of chewing and biting; Q3: My gums do not feel sore at the end of the day; Q4: My gums are not irritated by trapped food particles under my denture(s); Q5: My gums do not feel tired at the end of the day. The participants recorded the response on scale of 0-4: 0-Agree Strongly, 1-Agree Somewhat, 2-Neither Agree or Disagree, 3-Disagree Somewhat, 4- Disagree Strongly). Total score range is 0-20 where lower score indicated better results.
Secondary Outcomes
- Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire After 1, 4 and 8 Weeks(At Baseline and after 1 week, 4 weeks and 8 weeks)
- Gum Health Analysis by Change From Baseline in Mean Scores of Participant Responses to the Individual Questions on the Gum Comfort Questionnaire After 1, 4, 8 and 12 Weeks.(At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeks)
- Mucosal Health Analysis of Denture Bearing Tissues by Change From Baseline in Mucosal Score Assessment (MSA) After 1, 4, 8 and 12 Weeks(At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeks)
- Oral Health Related Quality of Life (OHrQoL) Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Oral Health Impact Profile for Edentulous Patients (OHIP)-Edent Questionnaires After 1, 4, 8 and 12 Weeks(At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeks)
- OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the OHIP-Edent Questionnaires After 1, 4, 8 and 12 Weeks(At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeks)
- OHrQoL Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the General Oral Health Assessment Index (GOHAI) Questionnaires After 1, 4, 8 and 12 Weeks(At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeks)
- OHrQoL Analysis by Change From Baseline in Average Domain Scores of Participant Responses to the GOHAI Questionnaires After 1, 4, 8 and 12 Weeks(At Baseline and after 1 week, 4 weeks, 8 weeks and 12 weeks)
- Mean Scores of Participant Responses to the Sensory Questionnaire at Week 4(At week 4)