To Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Single-blind, Efficacy Study to Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive

Conditions
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Denture Retention

Intervention / Treatment
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* Drug: Experimental Denture Adhesive


Participation Criteria
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Eligibility Criteria
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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 <1. 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. Participant has not used any denture adhesive in the last year. Participant currently adopts acceptable denture cleansing habits and routine (a minimum would include daily brushing with a chemical cleaner such as toothpaste or soap, in addition to at least once a week soaking in commercial denture cleansing product). Unacceptable cleaning would include cleaning with water alone or using other non-specialized cleaning methods. 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. Participants should continue using their usual denture cleansing methodology throughout the study. A participant who has previously been enrolled in this study. A participant who has had recent (within 30 days) gingival surgery. Taking or have taken a bisphosphonate drug (i.e. Fosamax, Actonel, Boniva). A participant with any clinically significant or relevant oral abnormality (e.g. temporomandibular joint problems) that, in the opinion of the investigator, could affect the Participant's participation in the study. A participant with any condition or medication which, in the opinion of the investigator, is currently causing xerostomia. A participant with recent history (within the last year) of alcohol or other substance abuse. A participant with OST examination findings such as stomatitis, open sores, lesions, or swelling which in the opinion of the investigator, would interfere with the conduct of the study. Mild, chronic conditions commonly expected from the use of dentures in the investigators opinion, are acceptable in this study. A participant who is using any medication that, in the opinion of the investigator, would interfere with the conduct of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental denture adhesive<br>In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth. | Drug: Experimental Denture Adhesive<br>* In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.<br>|
| No Intervention: No adhesive<br>In this arm, participants will not use any denture adhesive. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gum Health Analysis by Change From Baseline in Overall Mean Scores of Participant Responses to the Gum Comfort Questionnaire 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. | At Baseline and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 1, 4 and 8 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, 3-Neither Agree or Disagree, 4= Disagree Strongly). Total score range is 0-20 where lower score indicated better results. | 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. | 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 1, 4, 8 and 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, 3-Neither Agree or Disagree, 4= Disagree Strongly). Total score range is 0-20 where lower score indicated better results. | 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 | MSA used by dentist to assess health of denture bearing tissues of participants across whole mouth on scale:1-4,1- normal appearance of gingiva,oral mucosa,2-mild inflammation(slight redness and/or hypertrophy/hyperplasia of gingiva and slight redness in some areas of palatal mucosa,including red spots indicating inflamed salivary duct orifices),3-moderate inflammation(marked redness and hypertrophy/hyperplasia of the gingiva, in large ares of palate, in oral mucosa, ulceration caused by denture, red and inflamed fibro-epithelial hyperplasia caused by denture),4-severe inflammation(severe redness and hypertrophy/hyperplasia of gingiva,spontaneous gingival bleeding, marked palatal granulations, inflamed oral mucosa areas).MSA was performed on denture-bearing tissues for either/both dentures across whole mouth and examiner recorded highest applicable score. Lower score indicated better results. | 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 | OHIP-Edent questionnaire was used for the evaluation of OHrQoL. This questionnaire was comprised of 19 questions grouped into 6 functional domains and the participants responded on the scale of 0-4: 0-never, 1-rarely, 2-occasionally, 3-often and 4-very often. The functional domains are: domain 1- functional limitations (questions 1-3, score range 0-12), domain 2- physical pain (questions 4-7, score range 0-16), domain 3- psychological discomfort (questions 8-9, score range 0-8), domain 4- physical disability (questions 10-12, score range 0-12), domain 5- psychological disability (questions 13-14, score range 0-8) and domain 6- social disability (questions 15-19, score range 0-20). The overall score range is 0-76 where 0 is the best possible score. Lower scores represent a more favorable perception of participants OHrQoL. | 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 | OHIP-Edent questionnaire was used for the evaluation of OHrQoL. This questionnaire was comprised of 19 questions grouped into 6 functional domains and the participants responded on the scale of 0-4: 0-never, 1-rarely, 2-occasionally, 3-often and 4-very often. The functional domains are: domain 1- functional limitations (questions 1-3, score range 0-12), domain 2- physical pain (questions 4-7, score range 0-16), domain 3- psychological discomfort (questions 8-9, score range 0-8), domain 4- physical disability (questions 10-12, score range 0-12), domain 5- psychological disability (questions 13-14, score range 0-8) and domain 6- social disability (questions 15-19, score range 0-20). The overall score range is 0-76 where 0 is the best possible score. Lower scores represent a more favorable perception of participants OHrQoL. | 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 | GOHAI questionnaire was used for the evaluation of OHrQoL. It was comprised of 12 questions with 6 possible responses. The participants responded on the scale of 0-5: 0-always, 1-very often, 2-often, 3-sometimes, 4-seldom and 5-never. The functional domain of the questionnaire are as: domain 1: functional (questions 1-4, score range 0-20, participant's ability to eat, speak and swallow); domain 2: psychological (questions 6,7,9-11, score range 0-25, participant's concerns, relationships and appearance); domain 3- pain/ discomfort (questions 5,8,12, score range 0-15, participant's discomfort during chewing, sensitivity to hot/cold/sweets and use of medications to manage oral pain). The responses were scored on a 0 (always)-5 (never) scale for all questions except 3, 5 and 7 where the scoring is reversed, and thus the range of scores for the questionnaire is 0-60, where 60 is the best possible score. Higher score indicated better results. | 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 | GOHAI questionnaire was used for the evaluation of OHrQoL. It was comprised of 12 questions with 6 possible responses. The participants responded on the scale of 0-5: 0-always, 1-very often, 2-often, 3-sometimes, 4-seldom and 5-never. The functional domain of the questionnaire are as: domain 1: functional (questions 1-4, score range 0-20, participant's ability to eat, speak and swallow); domain 2: psychological (questions 6,7,9-11, score range 0-25, participant's concerns, relationships and appearance); domain 3- pain/ discomfort (questions 5,8,12, score range 0-15, participant's discomfort during chewing, sensitivity to hot/cold/sweets and use of medications to manage oral pain). The responses were scored on a 0 (always)-5 (never) scale for all questions except 3, 5 and 7 where the scoring is reversed, and thus the range of scores for the questionnaire is 0-60, where 60 is the best possible score. Higher score indicated better results. | 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 | Sensory attributes of the adhesive was assessed by sensory questionnaire which was comprised of 6 questions; Q1: I feel the product has a smooth texture on my gums, Q2: I feel the product is gentle on my gums, Q3: I feel the product flavor soothes my gums, Q4: I feel the product flavor cools my gums, Q5: I feel the product is easy to apply, Q6: I feel less rubbing from my denture throughout the day when using this product. This questionnaire was only referred to participants randomized to the experimental adhesive group. The participants responded for all questions on the scale of 0-4: 0-agree strongly,1-agree somewhat, 2-neither agree or disagree, 3-disagree somewhat, 4-disagree strongly. The total score range is 0-24 where a low score indicated better results. | At week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Denture, Adhesive, Gum-Health, Lifestyle