Denture LinersNCT03321500
Measuring Quality of Life of Versacryl Relined Dentures
A study testing Versacryl soft liner and Silicone-based soft liner in people with Denture Liners, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Denture Liners
- What is being tested?
- Versacryl soft liner and Silicone-based soft liner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous patients wearing complete dentures.
- Flat mandibular residual ridge.
- Mandibular denture indicated for relining.
- Patients with minimum of 2 years and maximum of 5 years complete denture usage.
- Angle's class I maxillary-mandibular relationship
Who cannot join
- Drug or alcohol abuse.
- Inflammatory changes in the oral cavity.
- Candidiasis.
- Any intra-oral soft tissue hyperplasia.
- Physical reasons that could affect follow-up.
- Psychiatric problems.
- Heavy smokers.
- Dentures indicated for remake.
Trial locations and contacts
No sites are listed yet.
Naglaa Noussohy contact
About this study
Official title: Comparative Study of Silicone-based Soft Liner Versus Versacryl Liner for Mandibular Complete Denture Cases(Randomized Clinical Trial)
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.
- Conditions
- Denture Liners
- Being tested
- Versacryl soft liner, Silicone-based soft liner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versacryl soft linerOther
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 linerOther
gold standard for denture relining material
| Study group | Role | What they receive |
|---|---|---|
| Versacyl soft liner | Experimental | 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 Receives: Other: Versacryl soft liner |
| Silicone-based soft liner | Active comparator | 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. Receives: Other: Silicone-based soft liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral health related quality of life
OHIP-49 questionnaire
Measured: 4 months
Secondary outcomes (1)
tissue keratinization
tissue keratinization index
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Denture LinersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Mohamed Moustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321500
- Sponsor's protocol ID
- versacryl_soft liners
- Status last verified
- Oct 2017
- First submitted
- 21 Oct 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26040175
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Silicone-based Soft Liner Versus Versacryl Liner for Mandibular Complete Denture Cases(Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03321500
- Acronym / sponsor ID
- versacryl_soft liners
- Conditions
- Denture Liners
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Versacyl soft liner | Experimental | Other: Versacryl soft linerVersacryl 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 |
| Silicone-based soft liner | Active comparator | Other: Silicone-based soft linerResilient 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completely edentulous patients wearing complete dentures.
- Flat mandibular residual ridge.
- Mandibular denture indicated for relining.
- Patients with minimum of 2 years and maximum of 5 years complete denture usage.
- Angle's class I maxillary-mandibular relationship
Key exclusion criteria (8 listed)
- Drug or alcohol abuse.
- Inflammatory changes in the oral cavity.
- Candidiasis.
- Any intra-oral soft tissue hyperplasia.
- Physical reasons that could affect follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Versacryl soft linerVersacryl 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. | Other | Versacyl soft liner |
| Silicone-based soft linergold standard for denture relining material | Other | Silicone-based soft liner |
Primary outcome
oral health related quality of life
Time frame: 4 months
OHIP-49 questionnaire
1 secondary outcome
tissue keratinization
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Background: PubMed 26040175Krunic 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naglaa Noussohy contact
Questions about this trial
What is this clinical trial studying?
A study testing Versacryl soft liner and Silicone-based soft liner in people with Denture Liners, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact menna mohammed shalabi, BDS (01111860078, MennaAllah.Mostafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral health related quality of life (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03321500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.