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Measuring Quality of Life of Versacryl Relined Dentures

Comparative Study of Silicone-based Soft Liner Versus Versacryl Liner for Mandibular Complete Denture Cases(Randomized Clinical Trial)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03321500
Enrollment
28
Registered
2017-10-25
Start date
2018-01-01
Completion date
2018-06-01
Last updated
2017-10-25

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

Conditions

Denture Liners

Brief summary

Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Due to drawbacks of conventional resilient liners, their longevity is questionable and they require replacement which is time consuming and costly for the dentist and patient respectively. Versacryl is a biocompatible intraoral thermo-elastic material. So versatile, it can be used to improve esthetics, retention and comfort for the patient. It softens with heat and when it is inserted to patient's mouth, it cools to body temperature providing desired rigidity. This process can be repeated many times to ensuring the comfort for the patient. Versacryl has a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material . The investigators' trial is done in order to improve the longevity and oral health related quality of life of soft liners in comparison to silicone-based soft liners.

Interventions

OTHERVersacryl soft liner

Versacryl has been used to construct different parts of complete and partial dentures . It can be used as thermo-elastic liner which consistency can be controlled to tailor the reline to each individual case, by adding or subtracting drops of liquid B, as explained in the directions for use. The reline can be re-adapted repeatedly, even by the patient if necessary.

OTHERSilicone-based soft liner

gold standard for denture relining material

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Completely edentulous patients wearing complete dentures. 2. Flat mandibular residual ridge. 3. Mandibular denture indicated for relining. 4. Patients with minimum of 2 years and maximum of 5 years complete denture usage. 5. Angle's class I maxillary-mandibular relationship

Exclusion criteria

1. Drug or alcohol abuse. 2. Inflammatory changes in the oral cavity. 3. Candidiasis. 4. Any intra-oral soft tissue hyperplasia. 5. Physical reasons that could affect follow-up. 6. Psychiatric problems. 7. Heavy smokers. 8. Dentures indicated for remake.

Design outcomes

Primary

MeasureTime frameDescription
oral health related quality of life4 monthsOHIP-49 questionnaire

Secondary

MeasureTime frameDescription
tissue keratinization4 monthstissue keratinization index

Contacts

Primary Contactmenna mohammed shalabi, BDS
MennaAllah.Mostafa@dentistry.cu.edu.eg01111860078
Backup ContactNaglaa Noussohy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026