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

NCT04942262 | Completed Phase 3 DMC

• 1 other identifier: HREC-DCU 2019-068
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Complete Denture; Complete Edentulism

Keywords

denture adhesive; oral impact; masticatory function; denture retention; denture stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Masticatory performance using the multiple sieve method of peanut particle.

  2 months

Study Arms (1)

denture adhesive use

EXPERIMENTAL

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)

Interventions

denture adhesive (Polident®, GlaxoSmithKline, Ireland) DRUG

cream-type denture adhesive available as an over-the-counter product in Thailand

Also known as: Polident

denture adhesive use

Eligibility Criteria

• Age: 40 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Dentistry, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (3)

• 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.

  PMID: 29195820 BACKGROUND

• 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.

  PMID: 20456031 RESULT

• 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.

  PMID: 30975019 RESULT

MeSH Terms

Interventions

Dental Cements; Polident; halofantrine

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Nareudee Limpuangthip

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: An external prosthodontist provided with a denture adhesive and knew who continued using denture adhesive. Meanwhile, the outcome assessor did not notice whether the participants continue using denture adhesive
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental staff at Department of Prosthodontics

Model Details: Before and after intervention, and then allow the participants to decide whether to continue receiving the intervention

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 28, 2021
• Study Start: January 31, 2019
• Primary Completion: January 17, 2020
• Study Completion: April 30, 2020
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)