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Effectiveness of a home care ultrasonic cleaner combined with immersion in peroxide-based cleanser in the mitigation of respiratory pathogens on dentures of institutionalised elderly: A randomised controlled clinical trial

Effectiveness of a home care ultrasonic cleaner combined with immersion in peroxide-based cleanser in the mitigation of respiratory pathogens on dentures of institutionalised elderly: A randomised controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102824
Enrollment
Unknown
Registered
2025-05-20
Start date
2025-02-17
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Pathogens on the Dentures

Interventions

Intervention ARM Group (ultrasonic and chemical cleaning):In the intervention arm participants will receive a portable and lightweight ultrasonic cleaner (Lohas ultrasonic cleaner GXZ UC01, Lohas Tech
Control ARM Group (conventional mechanical and chemical cleaning):To standardise the conventional mechanical brushing approach all participants will receive a commercially available denture brush (GUM

Sponsors

Faculty of Dentistry, The University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Participants will be adults who are wearing a complete or extensive partial maxillary or mandibular denture for at least 1 year and a maximum of 3 years. 2. Dentures fabricated with heat-polymerized acrylic resin and biofilm present on denture surfaces (as assessed by the semi-automated planimetric method). 3. Older adults of either sex and at least 60-year-old. 4. Ability to understand and provide informed consent [as assessed by Mini-Mental State Examination, mild and no cognitive impairment (scores=18) will be included] . 5. The denture has adequate retention and stability (as assessed by the Kapur index, retention scores >=2 and stability scores >=1 will be included).

Exclusion criteria

Exclusion criteria: 1. Participants have an indwelling nasogastric feeding tube or percutaneous endoscopic gastrostomy (unable to eat and drink normally). 2. Smoker (including e-cigarettes and tobacco chewing). 3. Participants are diagnosed with acquired immune deficiency syndrome, uncontrolled diabetes mellitus, anaemia, xerostomia, or immunosuppression. 4. Use of steroid treatment, antibiotics/antifungal medication, or undergoing radio- or chemotherapy within the past 4 weeks before recruitment and during follow-up. 5. The denture has been relined, repaired, or retained using denture adhesive products. 6. The denture with partially or completely ill-fitting/fracture. 7. Participants who are wearing dentures during meals only.

Design outcomes

Primary

MeasureTime frame
The prevalence (persistence + +, acquisition - +, transience/loss + -, and absence - -), abundance, and microbiome-based index (ORPI) of the respiratory pathogens or microbial index of pathogenic bacteria (MIP);

Secondary

MeasureTime frame
Denture plaque area coverage assessment;Prevalence of denture stomatitis;Patient-Reported Outcome Measures (PROMs);

Countries

China

Contacts

Public ContactLim Tong Wah

Faculty of Dentistry, The University of Hong Kong

tongwah@hku.hk+852 6151 5875

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026