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Operability and durability of autopolymerizing versus light curing materials for relining of removable dentures: A randomized controlled trial

Operability and durability of autopolymerizing versus light curing materials for relining of removable dentures: A randomized controlled trial - HIKAReline trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250051
Enrollment
120
Registered
2025-04-18
Start date
2025-06-09
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Poor fitness of the denture base

Interventions

Reline with autopolymerizing or light curing materials

Sponsors

Fueki Kenji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with removable dentures who present for oral maintenance care at the prosthetic clinic at Institute of Science Tokyo Hospital or Tokyo Dental College Suidobashi Hospital. 2.Patients who need reline due to a poor fit of the mandible denture base. 3.Patients who do not complain of mucosal pain. 4.Denture-bearing mucosa is in good condition with no redness or ulcer. 5.No occlusal problem in wearing dentures. 6.Denture abutment tooth mobility is less than 2 (Miller's Index). Miller's Index 0: Normal mobility 1: Slight mobility buccolingually 2: Moderate mobility buccolingually and mesiodistally 3: Moderate mobility buccolingually and mesiodistally, and depressible 7.18 years and older 8.Patients whose written consent to participate in this study has been obtained.

Exclusion criteria

Exclusion criteria: 1.Denture repairs other than reline is needed. 2.Patients who need a maxillary denture reline. 3.Thermoplastic resin removable denture wearers. 4.Hypersensitivity in denture-bearing mucosa. 5.Patients who always use denture adhesive or tissue conditioner. 6.Patients with hypersensitivity, such as rash or inflammation, to Tokuyama Rebase III, Tokuyama Hikareliner, methacrylate monomers, or organic solvents. 7.Other conditions that make participation in this study inappropriate are determined by the research dentists.

Design outcomes

Primary

MeasureTime frame
Operation time for completing the reline procedures

Secondary

MeasureTime frame
Denture quality (stability and retention, material durability) based on operator evaluation Denture usability based on patient evaluation Biting force Operator operability Time required for each step of the reline procedure Discomfort during relining Percentage of adverse events and failures

Contacts

Public ContactYuka Inamochi

Institute of Science Tokyo Hospital

y.inamochi.rpro@tmd.ac.jp+81-3-5803-5514

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026