Oral Health-related Quality of Life and Masticatory Function After Using Denture Adhesive and Denture Liner

Identifying Diagnostic Criteria of Denture Adhesive Use in Complete Denture Wearers: A Quasi-experimental Study

80 complete denture (CD) wearers participated in the quasi-experimental study. Two outcomes were: 1) oral health-related quality of life (OHRQoL) assessed using the Oral Impacts on Daily Performances index, and 2) masticatory performance, determined by a peanut particle size after 20-stroke mastication. Denture retention and stability were evaluated using the Chulalongkorn University (CU)-modified Kapur method to classify the CD into acceptable or unacceptable quality. Data were collected at 3-time points: 1) at baseline (T0), 2) after a 1-month trial of denture adhesive (DA) use (T1), at which time the participants decided whether to continue using DA, and 3) 1-month after continued or discontinued using DA (T2).

Study Overview

• Status: Completed
• Conditions: Complete Edentulism; Complete Denture
• Intervention / Treatment: Drug: denture adhesive (Polident®, GlaxoSmithKline, Ireland)

Detailed Description

Participants The eligible participants were CD wearers randomly recruited from patients who visited the Prosthodontic clinic at the Faculty of Dentistry, Chulalongkorn University from 2015 to 2019. The inclusion criteria were patients who had worn removable maxillary and mandibular CDs for at least 6 months. The patients who wore a metal-based denture, had a history of DA use, had difficulty in responding to the interview, or were unwilling to follow the study protocol were excluded from the study.

Outcomes The primary outcome was OHRQoL determined using the Thai-version of Oral Impacts on Daily Performances index. The participants were interviewed whether they had difficulties in performing the following 8 daily activities: eat, speak, clean denture and mouth, sleep, smile, emotional stability, social contact, and carry out work or housework. The frequency and severity of each impact were rated using a five-point Likert scale, and their multiplication gave a condition-specific impact score. The overall oral impact score was the sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence (score = 0) or presence of an oral impact (score > 0). The changes in oral impact score from T0 to T1 were categorized into 3 types: decreased (T0 score > T1 score), increased (T0 score < T1 score), and remained absent (T0 score = T1 score = 0).

The secondary outcome was masticatory performance assessed using the multiple sieve method of peanut mastication. The participants masticated 3 grams of roasted peanuts for 20 strokes in triplicate with a 15-minute resting interval between each test. The comminuted peanut particles were dried and sieved through 12 standard test sieves (Test sieve; Retcsh Technology GmbH) on a vibrating sieve shaker. A simple linear regression was plotted between the cumulative weight and diameter of each sieve test. The median peanut particle size (mm) was the sieve diameter through which 50% of the comminuted peanut particles passed. A smaller peanut particle size reflected a higher masticatory performance.

Intervention An external prosthodontist provided a cream-type DA (Polident®, GlaxoSmithKline, Ireland), and instructed the participants to use the DA cream once a day in the morning and use it throughout the day. They applied the DA onto maxillary and mandibular dentures on the tissue surface using a spot method. The participants had to remove the DA and clean the denture every day after the last meal by soaking and brushing the CD with liquid soap and a soft toothbrush under running tap water. Two gauze pads were used to remove DA from the denture and oral mucosa.

The OHRQoL, masticatory performance, and CD-quality were evaluated at 3-time points:

1. T0, at baseline before using the DA. The baseline information regarding the outcomes was evaluated. Then, the participants underwent a daily 1-month trial of DA use,
2. T1 (T0 + 1 month), after the 1-month trial period of DA use. The outcomes were evaluated with all participants using DA. The external prosthodontist asked the participants to choose whether they wanted to continue or discontinue using DA, and
3. T2 (T0 + 2 months), at 1-month after continuing or discontinuing DA use. At this time, some participants used DA during the outcome evaluations, while some did not, depending on the patient's decision on DA use.

A single-blind clinical trial protocol was created. One of the investigators (B.T.) performed the outcome assessment who did not notice whether the participants continue using DA.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Faculty of Dentistry, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Wear removable maxillary and mandibular complete dentures for at least 6 months.

Exclusion Criteria:

• Wear a metal-based denture
• Have a history of DA use
• Unable to respond to the interview
• Unwilling to follow the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: denture adhesive use; Participants were instructed to use a cream-type denture adhesive (Polident®, GlaxoSmithKline, Ireland) once a day in the morning and use it throughout the day. They applied denture adhesive onto the tissue surface of their maxillary and mandibular dentures using a spot method. The participants had to remove the DA and clean the denture every day after the last meal by soaking and brushing the CD with liquid soap and a soft toothbrush under running tap water. Two gauze pads were used to remove DA from the denture and oral mucosa. After the 1-month trial period of DA use. The outcomes were evaluated with all participants using DA, and they had to choose whether they wanted to continue or discontinue using DA for another 1 month. At 1-month after continuing or discontinuing DA use. At this time, some participants used DA during the outcome evaluations, while some did not, depending on the patient's decision on DA use.

Drug: denture adhesive (Polident®, GlaxoSmithKline, Ireland); cream-type denture adhesive available as an over-the-counter product in Thailand; Other Names: Polident

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health-related quality of life (OHRQoL)	The OHRQoL was assessed using the oral impacts on daily performances (OIDP) index. The participants were interviewed about whether they had difficulties in performing the following 8 daily activities within physical, psychological and social performances: eating, speaking and pronouncing, cleaning denture and mouth, sleeping, smiling, emotional stability, social contact, and carrying out work or housework. The frequency and severity of each impact were rated using a five-point Likert scale, and their multiplication gave a condition-specific (CS) impact score. The overall oral impact score was the sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence (score = 0) or presence of an oral impact (score > 0).	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Masticatory performance using the multiple sieve method of peanut particle.	The participants masticated 3 grams of roasted peanuts for 20 strokes in triplicate with a 15-minute resting interval between each test. The comminuted peanut particles were dried and sieved through 12 standard test sieves (Test sieve; retch Technology GmbH) on a vibrating sieve shaker. A simple linear regression was plotted between the cumulative weight and diameter of each sieve test. The median peanut particle size (mm) was the sieve diameter through which 50% of the comminuted peanut particles passed. A smaller peanut particle size reflected a higher masticatory performance.	2 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Nareudee Limpuangthip, Chulalongkorn University

Publications and helpful links

General Publications

• Limpuangthip N, Somkotra T, Arksornnukit M. Modified retention and stability criteria for complete denture wearers: A risk assessment tool for impaired masticatory ability and oral health-related quality of life. J Prosthet Dent. 2018 Jul;120(1):43-49. doi: 10.1016/j.prosdent.2017.09.010. Epub 2017 Nov 29.
• Nicolas E, Veyrune JL, Lassauzay C. A six-month assessment of oral health-related quality of life of complete denture wearers using denture adhesive: a pilot study. J Prosthodont. 2010 Aug;19(6):443-8. doi: 10.1111/j.1532-849X.2010.00601.x. Epub 2010 Apr 29.
• Ohwada G, Minakuchi S, Sato Y, Kondo H, Nomura T, Tsuboi A, Hong G, Itoh Y, Kawai Y, Kimoto S, Gunji A, Suzuki A, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Subjective Evaluation of Denture Adhesives: A Multicenter Randomized Controlled Trial. JDR Clin Trans Res. 2020 Jan;5(1):50-61. doi: 10.1177/2380084419837607. Epub 2019 Apr 11.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: denture adhesive; oral impact; masticatory function; denture retention; denture stability
• Other Study ID Numbers: HREC-DCU 2019-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No