Edentulous JawNCT03687047
Impact of the Use of New Complete Denture on the Oral Health Related to Quality of Life (OHRQoL)
A study testing New complete dentures in people with Edentulous Jaw and Quality of Life, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The aim of this project was to evaluate the impact before and after (3, 6, 9, and 12 months) of oral rehabilitation with conventionalof the insertion of new complete dentures (CD) in the oral health-related quality of life (OHRQoL) in total edentulous patients compared to dentate individuals. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw, Quality of Life
- What is being tested?
- New complete dentures
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Mar 2017to 1 Dec 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy patients without disabilities;
- aged up to 50 years;
- patient with complete upper and or lower jaw edentulism for a minimum 5 years;
- patient with presence of adequate healthy tissue to support the prosthesis;
- patient with adequate cognitive ability and understanding to respond to the questions posed
Who cannot join
- patient with motor disabilities;
- patient with cognitive impairment
- people with special needs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Fluminense
Nova Friburgo, Rio de Janeiro, 28625650
About this study
Official title: Evaluation the Impact of the Use of New Complete Denture (Prothesis) on the OHRQoL in Total Edentulous Patients Comparing to Dentate Individuals
The aim of this project was to evaluate the impact before and after (3, 6, 9, and 12 months) of oral rehabilitation with conventionalof the insertion of new complete dentures (CD) in the oral health-related quality of life (OHRQoL) in total edentulous patients compared to dentate individuals. This is a clinical trial study approved by the Research Ethics Committee (nº 31105714.7.0000.5626 ) which was conducted on 122 patients who attended the clinics of Federal Fluminense University, with the necessity of CD. The eligibility criteria were: healthy patients without disabilities; aged up to 50 years; complete upper and or lower jaw edentulism for a minimum 5 years; the presence of adequate healthy tissue to support the prosthesis; adequate cognitive ability and understanding to respond to the questions posed. It will be excluded patient with motor disabilities, cognitive impairment and people with special needs. After the installation of the CD a follow-up of one week, three, six, nine, twelve and eighteen months will be performed. The Oral Health Impact Profile (OHIP-Edent) instrument will be applied (in form of an interview) to evaluate the impact of CD on OHRQoL. The scores of the OHIP-Edent index will be calculated using the additive method, summing the numeric response codes for each item. Shapiro-Wilk test revealed nonparametric distribution of data. Chi-square, Mann-Whitney U, and Kruskal-Wallis tests were performed for comparing groups according to sociodemographic data. Kruskal-Wallis test was per- formed for comparing groups and treatments throughout time. A significance level of 5% was adopted, and all analyses were performed on Statistical Analysis System (SAS) version 9.3 software. The responsiveness was assessed by analyzing the change of the scores on the scales and subscales. The changes was calculated by subtracting the post-treatment scores from the before-treatment scores. Positive change scores will indicate an improvement in OHRQoL, while negative scores will indicate deterioration.
- Conditions
- Edentulous Jaw, Quality of Life
- Being tested
- New complete dentures
- Keywords
- DENTADURES, EDENTULOUS, MASTIGATORY PERFORMANCE
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New complete denturesDevice
Preliminary impressions using stock trays and impression compound; primary casts fabricated to make custom trays for definitive impressions; definitive impressions using zinc oxide eugenol impression paste; definitive impressions poured with type III dental stone to obtain mastercasts; jaw relations will be recorded, and the casts will be mounted on the articulator; the artificial acrylic resin teeth will be arranged, esthetics will be verified, and the trial dentures will be flasked and polymerized (72°C per 12 hours). The dentures will be finished and polished for insertion and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| New complete dentures | Experimental | Steps: 1) Preliminary impressions will be done using stock trays and impression compound; 2) primary casts will be fabricated to make custom trays for definitive impressions; 3) definitive impressions will be made using zinc oxide eugenol impression paste;4) definitive impressions will be poured with type III dental stone to obtain mastercasts; 5)jaw relations will be recorded, and the casts will be mounted on the articulator; 6) the artificial acrylic resin teeth will be arranged, esthetics will be verified, and the trial dentures will be flasked and polymerized (72°C per 12 hours). The dentures will be finished and polished for insertion and follow-up. After denture insertion, post-denture insertion instructions such as oral hygiene will be explained to the patients.
The Oral Health Related to Quality of Life assessment will be conducted before treatment (Baseline) and at 3, 6, 9, 12 months after treatment. Receives: Device: New complete dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of oral heath related to quality of life from edentulous patient after use new complete denture
After the installation of the new prothesis (complete denture) a follow-up (one week, three, six, nine, twelve months) will be performed. The Oral Health Impact Profile (OHIP-Edent) instrument will be applied (in form of interview) to evaluate the impact of new prothesis (complete denture) on OHRQoL.
Measured: 12 MESES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start25 Mar 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Azeredo Alves Antunes, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687047
- Sponsor's protocol ID
- Complete denture and OHRQoL
- Status last verified
- Nov 2022
- First submitted
- 20 Sep 2018
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Impact of the Use of New Complete Denture (Prothesis) on the OHRQoL in Total Edentulous Patients Comparing to Dentate Individuals
- ClinicalTrials.gov ID
- NCT03687047
- Acronym / sponsor ID
- Complete denture and OHRQoL
- Conditions
- Edentulous Jaw, Quality of Life
- Keywords
- DENTADURES, EDENTULOUS, MASTIGATORY PERFORMANCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 27 Sep 2018 (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.
The aim of this project was to evaluate the impact before and after (3, 6, 9, and 12 months) of oral rehabilitation with conventionalof the insertion of new complete dentures (CD) in the oral health-related quality of life (OHRQoL) in total edentulous patients compared to dentate individuals. This is a clinical trial study approved by the Research Ethics Committee (nº 31105714.7.0000.5626 ) which was conducted on 122 patients who attended the clinics of Federal Fluminense University, with the necessity of CD. The eligibility criteria were: healthy patients without disabilities; aged up to 50 years; complete upper and or lower jaw edentulism for a minimum 5 years; the presence of adequate healthy tissue to support the prosthesis; adequate cognitive ability and understanding to respond to the questions posed. It will be excluded patient with motor disabilities, cognitive impairment and people with special needs. After the installation of the CD a follow-up of one week, three, six, nine, twelve and eighteen months will be performed. The Oral Health Impact Profile (OHIP-Edent) instrument will be applied (in form of an interview) to evaluate the impact of CD on OHRQoL. The scores of the OHIP-Edent index will be calculated using the additive method, summing the numeric response codes for each item. Shapiro-Wilk test revealed nonparametric distribution of data. Chi-square, Mann-Whitney U, and Kruskal-Wallis tests were performed for comparing groups according to sociodemographic data. Kruskal-Wallis test was per- formed for comparing groups and treatments throughout time. A significance level of 5% was adopted, and all analyses were performed on Statistical Analysis System (SAS) version 9.3 software. The responsiveness was assessed by analyzing the change of the scores on the scales and subscales. The changes was calculated by subtracting the post-treatment scores from the before-treatment scores. Positive change scores will indicate an improvement in OHRQoL, while negative scores will indicate deterioration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New complete dentures | Experimental | Device: New complete denturesSteps: 1) Preliminary impressions will be done using stock trays and impression compound; 2) primary casts will be fabricated to make custom trays for definitive impressions; 3) definitive impressions will be made using zinc oxide eugenol impression paste;4) definitive impressions will be poured with type III dental stone to obtain mastercasts; 5)jaw relations will be recorded, and the casts will be mounted on the articulator; 6) the artificial acrylic resin teeth will be arranged, esthetics will be verified, and the trial dentures will be flasked and polymerized (72°C per 12 hours). The dentures will be finished and polished for insertion and follow-up. After denture insertion, post-denture insertion instructions such as oral hygiene will be explained to the patients. The Oral Health Related to Quality of Life assessment will be conducted before treatment (Baseline) and at 3, 6, 9, 12 months after treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy patients without disabilities;
- aged up to 50 years;
- patient with complete upper and or lower jaw edentulism for a minimum 5 years;
- patient with presence of adequate healthy tissue to support the prosthesis;
- patient with adequate cognitive ability and understanding to respond to the questions posed
Key exclusion criteria (3 listed)
- patient with motor disabilities;
- patient with cognitive impairment
- people with special needs.
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 |
|---|---|---|
| New complete denturesPreliminary impressions using stock trays and impression compound; primary casts fabricated to make custom trays for definitive impressions; definitive impressions using zinc oxide eugenol impression paste; definitive impressions poured with type III dental stone to obtain mastercasts; jaw relations will be recorded, and the casts will be mounted on the articulator; the artificial acrylic resin teeth will be arranged, esthetics will be verified, and the trial dentures will be flasked and polymerized (72°C per 12 hours). The dentures will be finished and polished for insertion and follow-up. | Device | New complete dentures |
Primary outcome
Evaluation of oral heath related to quality of life from edentulous patient after use new complete denture
Time frame: 12 MESES
After the installation of the new prothesis (complete denture) a follow-up (one week, three, six, nine, twelve months) will be performed. The Oral Health Impact Profile (OHIP-Edent) instrument will be applied (in form of interview) to evaluate the impact of new prothesis (complete denture) on OHRQoL.
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 30 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New complete dentures in people with Edentulous Jaw and Quality of Life, run by Universidade Federal Fluminense at 1 site in Brazil.
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 3 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 30 Nov 2022. 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?
Evaluation of oral heath related to quality of life from edentulous patient after use new complete denture (time frame: 12 MESES). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2022.