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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
119
In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.
GSK Investigational Site
Mississauga, Canada
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.
Time frame: At Baseline and after 12 weeks
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.
Time frame: 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.
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At week 4