Measuring Quality of Life of Versacryl Relined Dentures

NCT ID: NCT03321500

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Denture Liners

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Versacyl soft liner

Versacryl soft liner are flexible biocompatible materials with 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

Group Type EXPERIMENTAL

Versacryl soft liner

Intervention Type OTHER

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.

Silicone-based soft liner

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. Resilient liners also known as 'soft liners' can be classified as temporary or permanent, cold-cured or heat-cured.Resilient liners can be divided into two main types: plasticized acrylic resins and silicone elastomers.

Group Type ACTIVE_COMPARATOR

Silicone-based soft liner

Intervention Type OTHER

gold standard for denture relining material

Interventions

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Versacryl 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.

Intervention Type OTHER

Silicone-based soft liner

gold standard for denture relining material

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mennatallah Mohamed Moustafa

Internal resident at removable prosthodontic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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menna mohammed shalabi, BDS

Role: CONTACT

Phone: 01111860078

Email: [email protected]

Naglaa Noussohy

Role: CONTACT

References

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Krunic N, Kostic M, Petrovic M, Igic M. Oral health-related quality of life of edentulous patients after complete dentures relining. Vojnosanit Pregl. 2015 Apr;72(4):307-11. doi: 10.2298/vsp1504307k.

Reference Type BACKGROUND
PMID: 26040175 (View on PubMed)

Other Identifiers

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versacryl_soft liners

Identifier Type: -

Identifier Source: org_study_id