Quality of LifeOHRQoLNCT01928706

Quality of Life After Denture Relining

A study testing Denture liner Mucopren Soft; Group 1 and Denture liner Kooliner; Group 2 in people with Quality of Life, run by Fundação de Amparo à Pesquisa do Estado de São Paulo at 1 site in Brazil.

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 aim of the present study was to analyze the impact of mandibular denture relining with soft or hard denture liners in the oral health related quality of life (OHRQoL) of edentulous patients. Read more about this study

Who is it for?: Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Quality of Life
What is being tested?: Denture liner Mucopren Soft; Group 1 and Denture liner Kooliner; Group 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteBrazil
Study dates: Mar 2009to May 2012
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 40 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Edentulous in both jaws
Complete denture wearers
Clinically acceptable occlusal relationships
Healthy mucosa, i.e. with no signs of inflammation, traumatic lesions, candidiasis or hyperplasia.

Who cannot join

Residual vertical bone height of 10 mm or less
No attached mucosa in any region of mandible (type E)
Dentures with deteriorated intaglio surfaces
Dentures with large pre-existing fractures
Dentures with severely altered occlusal vertical dimension
Extremely worn artificial teeth

Show all 13Show fewer

Dentures with unsatisfactory occlusions
Neurological diseases
Lack of motor coordination
Difficulty of understanding instructions and the conditions of the study
Patients with residual roots, cysts or bone spicules
Patients with allergies to methyl methacrylate or silicone
Knife-edge mandibular ridges.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Ribeirao Preto Dental School University of Sao Paulo
Ribeirão Preto, São Paulo, 14.040-904

Other trials in Brazil

About this study

Official title: Oral Health Related Quality of Life of Edentulous Patients After Relining Mandibular Dentures With Soft and Hard Denture Liners.

The null hypothesis was that there would be no difference in OHRQoL findings after mandibular denture relining between patient groups treated with hard or soft denture liners.

Read the detailed description

Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22) or a hard acrylic resin based denture liner (Kooliner; Group 2; control n=22) with chairside procedures. The OHIP EDENT (Oral Health Impact profile) questionnaire was given to patients prior to reline procedures (baseline-T0) and 90 days (T90) post relining. Three possible answers and scores were proposed for each question: never (0), sometimes (1) and almost always (2). Results were analyzed by means of the generalized linear model (p≤0.05) considering two factors: time (T0 and T90) and group (hard and soft denture liners).

Conditions: Quality of Life
Being tested: Denture liner Mucopren Soft; Group 1, Denture liner Kooliner; Group 2
Keywords: edentulism, denture liner, prosthodontics, OHIP EDENT

What participants receive

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

Denture liner Mucopren Soft; Group 1Other
Also called Mucopren Soft relining
Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22)
Denture liner Kooliner; Group 2Other
Also called Kooliner
Complete denture wearers had their existing mandibular dentures relined with a hard acrylic resin based denture liner (Kooliner; Group 2;n=22) with chairside procedures.

Study groups in NCT01928706
Study group	Role	What they receive
Denture liner Mucopren Soft; Group 1	Experimental	The existing mandibular dentures were relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22). Receives: Other: Denture liner Mucopren Soft; Group 1
Denture liner Kooliner; Group 2	Active comparator	The existing mandibular dentures were relined with a a hard acrylic resin based denture liner (Kooliner; Group 2 n=22). Receives: Other: Denture liner Kooliner; Group 2

What is being measured

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

Change from Baseline in Oral health related quality of life at 90 days after denture relining
The Oral Health Related Quality of Life (OHRQoL) was assessed through the application of the questionnaire OHIP EDENT at baseline and 90 days post denture relining. Four domains developed for the Brazilian OHIP-EDENT9 were used: (D1) 'masticatory-related complaints, (D2) 'psychological discomfort and disability', (D3) 'social disability' and (D4) 'oral pain and discomfort'.
The questionnaires were carried out via interviews by one individual examiner , who was blinded for the denture liner. The interviews lasted approximately ten minutes.Three possible answers to questions one to nineteen with their scores in parenthesis were given as options: never (0), sometimes (1) or almost always (2).
Measured: The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post denture relining.

Timeline

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

Mar 2009May 2012

First posted27 Aug 2013 (estimated)
Study startMar 2009
Primary completionFeb 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Quality of LifeStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01928706
Sponsor's protocol ID: 24021985
Acronym: OHRQoL
Status last verified: Aug 2013
First submitted: 6 Aug 2013
Last updated: 27 Aug 2013
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Health Related Quality of Life of Edentulous Patients After Relining Mandibular Dentures With Soft and Hard Denture Liners.
ClinicalTrials.gov ID: NCT01928706
Acronym / sponsor ID: OHRQoL / 24021985
Conditions: Quality of Life
Keywords: edentulism, denture liner, prosthodontics, OHIP EDENT
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Fundação de Amparo à Pesquisa do Estado de São PauloOther government
Study start: Mar 2009
Primary completion: Feb 2012 (actual)
Study completion: May 2012 (actual)
First posted: 27 Aug 2013 (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.

The null hypothesis was that there would be no difference in OHRQoL findings after mandibular denture relining between patient groups treated with hard or soft denture liners.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Denture liner Mucopren Soft; Group 1	Experimental	Other: Denture liner Mucopren Soft; Group 1The existing mandibular dentures were relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22).
Denture liner Kooliner; Group 2	Active comparator	Other: Denture liner Kooliner; Group 2The existing mandibular dentures were relined with a a hard acrylic resin based denture liner (Kooliner; Group 2 n=22).

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Edentulous in both jaws
Complete denture wearers
Clinically acceptable occlusal relationships
Healthy mucosa, i.e. with no signs of inflammation, traumatic lesions, candidiasis or hyperplasia.

Key exclusion criteria (13 listed)

Residual vertical bone height of 10 mm or less
No attached mucosa in any region of mandible (type E)
Dentures with deteriorated intaglio surfaces
Dentures with large pre-existing fractures
Dentures with severely altered occlusal vertical dimension

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
Denture liner Mucopren Soft; Group 1Also: Mucopren Soft reliningComplete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22)	Other	Denture liner Mucopren Soft; Group 1
Denture liner Kooliner; Group 2Also: KoolinerComplete denture wearers had their existing mandibular dentures relined with a hard acrylic resin based denture liner (Kooliner; Group 2;n=22) with chairside procedures.	Other	Denture liner Kooliner; Group 2

Primary outcome

Change from Baseline in Oral health related quality of life at 90 days after denture relining
Time frame: The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post denture relining.
The Oral Health Related Quality of Life (OHRQoL) was assessed through the application of the questionnaire OHIP EDENT at baseline and 90 days post denture relining. Four domains developed for the Brazilian OHIP-EDENT9 were used: (D1) 'masticatory-related complaints, (D2) 'psychological discomfort and disability', (D3) 'social disability' and (D4) 'oral pain and discomfort'. The questionnaires were carried out via interviews by one individual examiner , who was blinded for the denture liner. The interviews lasted approximately ten minutes.Three possible answers to questions one to nineteen with their scores in parenthesis were given as options: never (0), sometimes (1) or almost always (2).

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 27 Aug 2013.

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RecruitingObservational study
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Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
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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.

C H Lovato, pHD principal investigator

Ribeirao Preto Dental School University of Sao Paulo

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 13 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 27 Aug 2013. 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 Brazil. 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?

Change from Baseline in Oral health related quality of life at 90 days after denture relining (time frame: The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post denture relining.). 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 NCT01928706.

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 27 Aug 2013.