Complete Mandibular Dentures With Poor RetentionNCT02203279

Evaluation of Three Hard Relining Materials in Complete Dentures

A study testing Rebase II Fast, Flexacryl and Vertex in people with Complete Mandibular Dentures With Poor Retention, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Purpose: The purpose of this study is to evaluate three hard relining materials after 3 and 6 months of use with mandibular complete dentures. The effect of hard relining materials on supporting tissues and patients' satisfaction will also be assessed. Read more about this study

Who is it for?: Ages 47 to 78 years, men only
Conditions the study is for: Complete Mandibular Dentures With Poor Retention
What is being tested?: Rebase II Fast, Flexacryl and Vertex
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSyria
Study dates: Jul 2014to Sep 2015
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 47 to 78 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 45-80 year,
complete maxillary and lower dentures
Mandibular dentures with poor retention

Who cannot join

Patients with good stability of mandibular dentures.
Partial maxillary edentulous patients

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Removable Prosthodontics, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18

Other trials in Syria

About this study

Official title: Evaluation of Three Hard Relining Materials in Complete Dentures: An In-vivo Study

Materials and Methods: 36 complete edentulous patients who already have maxillary dentures and complaining of instable mandibular dentures will be invited to participate in this study. Mandibular dentures will be relined randomly by one of three relining materials: two chairside relining materials (Tokuyama Rebase II Fast, Tokuyama Dental Co, Japan), and (Flexacryl Hard, Lang Co, USA) and one heat cured acrylic resin (Vertex, Dental technology Co, Holland).

The color stability of relining material, peeling, and the effect on supporting tissue will be assessed by two separate prosthodontists after 3 and 6 months of follow up. In addition, patients will be asked to grade there overall satisfaction on a Visual Analogue Scale (VAS) ranging from 0 to 100.

Read the detailed description

Relining denture is a process of resurfacing the tissue side of a denture to make it fit more accurately Direct relining of removable dentures with hard chair-side reline materials is suitable for improving the fit of the denture bases to the supporting tissues. Chairside reline materials are more convenient than those processed in a laboratory because the direct method is faster and does not cause clinically significant dimensional changes of the reline resin. However, when autopolymerized reline resins are used with a direct method, several problems can occur as burning sensation caused by monomers, an exothermic heat reaction and an unpleasant odor.

There are three types of hard relining chair-side materials: Dual-polymerized Visible light-polymerized as Triad DuaLine, Light Liner (Hard), Astron LC (Hard).Visible light-polymerized as Lightdon-U, Triad Hi-Flow Reline Material, Triad VLC Reline Material. Finally, autopolymerized as New Truline, Tokuyama Rebase II (Fast) , GC Reline. Other concerns related to direct reline materials include patient tolerance (taste, temperature, odor), color stability, durability and ease of handling and polishing.

Few studies evaluated the effect of disinfection solutions on relining materials properties as roughness and hardness. In one study, disinfectant solutions caused a decrease in hardness, whereas with roughness, the materials tested showed a statistically significant increase, except for Tokuyama. Depending on the examined relining materials, some materials have increased and the others have decreased surface roughness after immersion in disinfecting solutions or microwave disinfection.

All previous laboratory studies concentrated on the effects of disinfection on relining materials properties as roughness, hardness, color change. However, the clinical studies did not compare chemically cured and heat cured relining materials and their effects on supporting tissue. The aim of this study is to evaluate the clinical performance of two -chemically cured- and heat cured denture relining material after 3 and 6 months of use. In addition, the effect of hard relining materials on supporting tissues, and patients' satisfaction has not been evaluated yet.

Conditions: Complete Mandibular Dentures With Poor Retention
Being tested: Rebase II Fast, Flexacryl, Vertex
Keywords: Chair-side hard relining, complete denture, patients' satisfaction, supporting tissues, autopolymerized reline resins, heat cured relining material

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rebase II FastOther
It is going to be used a direct relining material
FlexacrylOther
This is going to be used as a second direct relining material
VertexOther
This is going to be used as an indirect relining material

Study groups in NCT02203279
Study group	Role	What they receive
Rebase II Fast	Experimental	The direct chair-side relining materiel 'Rebase II Fast' will be used. Receives: Other: Rebase II Fast
Flexacryl	Experimental	The direct chair-side relining material Flexacryl will be used Receives: Other: Flexacryl
Vertex	Experimental	Vertex is a heat-cured resin material which is going to be used for indirect relining Receives: Other: Vertex

What is being measured

The primary outcome is the main question the study is designed to answer.

Supporting Alveolar Mucosa Status_3
According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels:
Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues.
Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge.
Class III: The soft tissues appear in general as normal and fixed except for small isolated areas.
Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.
Measured: This will be measured at three months following relining
Supporting Alveolar Mucosa Status_6
According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels:
Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues.
Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge.
Class III: The soft tissues appear in general as normal and fixed except for small isolated areas.
Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.
Measured: This variable will be assessed at six months following relining
Color Stability_3
The color stability variable has four degrees on clinical examination:
1. no change
2. simple
3. medium
4. large
Measured: This will be assessed at three moths following relining

Secondary outcomes (5)

Color Stability_6
The color stability variable has four degrees on clinical examination:
no change simple medium large
Measured: This be assessed at six months following relining
Peeling_3
This variable is going to be inspected clinically and it has two categories:
1. peeling more than 4 mm
2. peeling less than 4 mm
Measured: This variable is going to be assessed at three months following relining
Peeling_6
This variable is going to be inspected clinically and it has two categories:
1. peeling more than 4 mm
2. peeling less than 4 mm
Measured: This variable is going to be assessed at six months following relining
Satisfaction_3
Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.
Measured: This is going to be measured at three months following relining
Satisfaction_6
Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.
Measured: This is going to be measured at six months following relining

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Sep 2015

First posted29 Jul 2014 (estimated)
Study startJul 2014
Primary completionAug 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Complete Mandibular Dentures With Poor RetentionStudies of the same condition, open and under way.
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: Single blind
Who is masked: Participant
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02203279
Sponsor's protocol ID: UDDS-RemPro-02-2014
Status last verified: Sep 2015
First submitted: 28 Jul 2014
Last updated: 29 Sep 2015
Results posted: No
Data monitoring committee: Yes

Publications

Al Rifaiy MQ. Shear bond strength between light polymerized hard reline resin and denture base resin subjected to long term water immersion. Saudi Dent J. 2012 Jan;24(1):23-7. doi: 10.1016/j.sdentj.2011.10.004. Epub 2011 Nov 20.
PubMed 23960524
Arima T, Murata H, Hamada T. Analysis of composition and structure of hard autopolymerizing reline resins. J Oral Rehabil. 1996 May;23(5):346-52. doi: 10.1111/j.1365-2842.1996.tb00863.x.
PubMed 8736448
Pinto Lde R, Acosta EJ, Tavora FF, da Silva PM, Porto VC. Effect of repeated cycles of chemical disinfection on the roughness and hardness of hard reline acrylic resins. Gerodontology. 2010 Jun;27(2):147-53. doi: 10.1111/j.1741-2358.2009.00282.x. Epub 2009 Jun 8.
PubMed 19508322
Haywood J, Basker RM, Watson CJ, Wood DJ. A comparison of three hard chairside denture reline materials. Part I. Clinical evaluation. Eur J Prosthodont Restor Dent. 2003 Dec;11(4):157-63.
PubMed 14737792
Hong G, Murata H, Li Y, Sadamori S, Hamada T. Influence of denture cleansers on the color stability of three types of denture base acrylic resin. J Prosthet Dent. 2009 Mar;101(3):205-13. doi: 10.1016/S0022-3913(09)60032-9.
PubMed 19231574
Machado AL, Breeding LC, Vergani CE, da Cruz Perez LE. Hardness and surface roughness of reline and denture base acrylic resins after repeated disinfection procedures. J Prosthet Dent. 2009 Aug;102(2):115-22. doi: 10.1016/S0022-3913(09)60120-7.
PubMed 19643225
Machado AL, Giampaolo ET, Vergani CE, Souza JF, Jorge JH. Changes in roughness of denture base and reline materials by chemical disinfection or microwave irradiation: surface roughness of denture base and reline materials. J Appl Oral Sci. 2011 Oct;19(5):521-8. doi: 10.1590/s1678-77572011000500015.
PubMed 21986658
Matsumura H, Tanoue N, Kawasaki K, Atsuta M. Clinical evaluation of a chemically cured hard denture relining material. J Oral Rehabil. 2001 Jul;28(7):640-4. doi: 10.1046/j.1365-2842.2001.00701.x.
PubMed 11422696
Murata H, Seo RS, Hamada T, Polyzois GL, Frangou MJ. Dynamic mechanical properties of hard, direct denture reline resins. J Prosthet Dent. 2007 Oct;98(4):319-26. doi: 10.1016/S0022-3913(07)60105-X.
PubMed 17936130
Ogle RE, Sorensen SE, Lewis EA. A new visible light-cured resin system applied to removable prosthodontics. J Prosthet Dent. 1986 Oct;56(4):497-506. doi: 10.1016/0022-3913(86)90397-5.
PubMed 3463760
Wyatt CC, Harrop TJ, MacEntee MI. A comparison of physical characteristics of six hard denture reline materials. J Prosthet Dent. 1986 Mar;55(3):343-6. doi: 10.1016/0022-3913(86)90117-4.
PubMed 3457166

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Three Hard Relining Materials in Complete Dentures: An In-vivo Study
ClinicalTrials.gov ID: NCT02203279
Acronym / sponsor ID: UDDS-RemPro-02-2014
Conditions: Complete Mandibular Dentures With Poor Retention
Keywords: Chair-side hard relining, complete denture, patients' satisfaction, supporting tissues, autopolymerized reline resins, heat cured relining material
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: Jul 2014
Primary completion: Aug 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 29 Jul 2014 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Rebase II Fast	Experimental	Other: Rebase II FastThe direct chair-side relining materiel 'Rebase II Fast' will be used.
Flexacryl	Experimental	Other: FlexacrylThe direct chair-side relining material Flexacryl will be used
Vertex	Experimental	Other: VertexVertex is a heat-cured resin material which is going to be used for indirect relining

Who may qualify

Ages: 47 to 78 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age between 45-80 year,
complete maxillary and lower dentures
Mandibular dentures with poor retention

Key exclusion criteria (2 listed)

Patients with good stability of mandibular dentures.
Partial maxillary edentulous patients

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
Rebase II FastIt is going to be used a direct relining material	Other	Rebase II Fast
FlexacrylThis is going to be used as a second direct relining material	Other	Flexacryl
VertexThis is going to be used as an indirect relining material	Other	Vertex

Primary outcome

Supporting Alveolar Mucosa Status_3
Time frame: This will be measured at three months following relining
According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels: Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues. Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge. Class III: The soft tissues appear in general as normal and fixed except for small isolated areas. Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.
Supporting Alveolar Mucosa Status_6
Time frame: This variable will be assessed at six months following relining
According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels: Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues. Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge. Class III: The soft tissues appear in general as normal and fixed except for small isolated areas. Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.
Color Stability_3
Time frame: This will be assessed at three moths following relining
The color stability variable has four degrees on clinical examination: 1. no change 2. simple 3. medium 4. large

5 secondary outcomes

Color Stability_6
Time frame: This be assessed at six months following relining
Peeling_3
Time frame: This variable is going to be assessed at three months following relining
Peeling_6
Time frame: This variable is going to be assessed at six months following relining
Satisfaction_3
Time frame: This is going to be measured at three months following relining
Satisfaction_6
Time frame: This is going to be measured at six months following relining

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
Background: PubMed 23960524Al Rifaiy MQ. Shear bond strength between light polymerized hard reline resin and denture base resin subjected to long term water immersion. Saudi Dent J. 2012 Jan;24(1):23-7. doi: 10.1016/j.sdentj.2011.10.004. Epub 2011 Nov 20.
Background: PubMed 8736448Arima T, Murata H, Hamada T. Analysis of composition and structure of hard autopolymerizing reline resins. J Oral Rehabil. 1996 May;23(5):346-52. doi: 10.1111/j.1365-2842.1996.tb00863.x.
Background: PubMed 19508322Pinto Lde R, Acosta EJ, Tavora FF, da Silva PM, Porto VC. Effect of repeated cycles of chemical disinfection on the roughness and hardness of hard reline acrylic resins. Gerodontology. 2010 Jun;27(2):147-53. doi: 10.1111/j.1741-2358.2009.00282.x. Epub 2009 Jun 8.
Background: PubMed 14737792Haywood J, Basker RM, Watson CJ, Wood DJ. A comparison of three hard chairside denture reline materials. Part I. Clinical evaluation. Eur J Prosthodont Restor Dent. 2003 Dec;11(4):157-63.
Background: PubMed 19231574Hong G, Murata H, Li Y, Sadamori S, Hamada T. Influence of denture cleansers on the color stability of three types of denture base acrylic resin. J Prosthet Dent. 2009 Mar;101(3):205-13. doi: 10.1016/S0022-3913(09)60032-9.
Background: PubMed 19643225Machado AL, Breeding LC, Vergani CE, da Cruz Perez LE. Hardness and surface roughness of reline and denture base acrylic resins after repeated disinfection procedures. J Prosthet Dent. 2009 Aug;102(2):115-22. doi: 10.1016/S0022-3913(09)60120-7.
Background: PubMed 21986658Machado AL, Giampaolo ET, Vergani CE, Souza JF, Jorge JH. Changes in roughness of denture base and reline materials by chemical disinfection or microwave irradiation: surface roughness of denture base and reline materials. J Appl Oral Sci. 2011 Oct;19(5):521-8. doi: 10.1590/s1678-77572011000500015.
Background: PubMed 11422696Matsumura H, Tanoue N, Kawasaki K, Atsuta M. Clinical evaluation of a chemically cured hard denture relining material. J Oral Rehabil. 2001 Jul;28(7):640-4. doi: 10.1046/j.1365-2842.2001.00701.x.
Background: PubMed 17936130Murata H, Seo RS, Hamada T, Polyzois GL, Frangou MJ. Dynamic mechanical properties of hard, direct denture reline resins. J Prosthet Dent. 2007 Oct;98(4):319-26. doi: 10.1016/S0022-3913(07)60105-X.
Background: PubMed 3463760Ogle RE, Sorensen SE, Lewis EA. A new visible light-cured resin system applied to removable prosthodontics. J Prosthet Dent. 1986 Oct;56(4):497-506. doi: 10.1016/0022-3913(86)90397-5.
Background: PubMed 3457166Wyatt CC, Harrop TJ, MacEntee MI. A comparison of physical characteristics of six hard denture reline materials. J Prosthet Dent. 1986 Mar;55(3):343-6. doi: 10.1016/0022-3913(86)90117-4.

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.

Omar Teriaky, DDS MSc principal investigator

PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus

Muhannad Alssadi, DDS MSc PhD study director

Associate Professor, Removable Prosthodontics Department, University of Damascus Dental School, Damascus

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rebase II Fast, Flexacryl and Vertex in people with Complete Mandibular Dentures With Poor Retention, run by Damascus University at 1 site in Syria.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Supporting Alveolar Mucosa Status_3 (time frame: This will be measured at three months following relining). The study lists 3 primary outcomes in all. 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 NCT02203279, which also lists 11 linked publications.

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 29 Sep 2015.