Edentulous MouthCEAIMPLANTNCT03056976
Cost-effectiveness of Implant Treatment for the Edentulous Mandible
A study testing Single-implant mandibular overdenture, Two-implant mandibular overdenture and Fixed mandibular denture in people with Edentulous Mouth, run by Universidade Federal de Goias.
Trial summary
The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants and the mandibular fixed prosthesis retained by four implants, based on a randomized clinical trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- Single-implant mandibular overdenture, Two-implant mandibular overdenture and Fixed mandibular denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No contraindications for implant surgery (mainly related to uncontrolled systemic diseases)
- Present enough bone volume in the mandible for implant placement without the need of bone augmentation procedures.
- Be able to understand and answer the questionnaires used in the study
- Agree to participate by providing a written informed consent.
Who cannot join
- Noncompliant participants
- Individuals who do not agree to be randomly allocated to the treatment study group
- Presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments
About this study
The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants and the mandibular fixed prosthesis retained by four implants, based on a randomized clinical trial.
Read the detailed description
This randomized clinical trial alongside a cost-effectiveness analysis will include 48 edentulous individuals who meet eligibility criteria. Participants will receive conventional complete denture treatment and will be randomized into three groups: single-implant mandibular overdenture group, mandibular overdenture retained by two implants, and fixed mandibular prosthodontics retained by four implants. CBCT and panoramic radiographs will be obtained to assess if bone sites in three-dimensional terms have a minimum volume for receiving implants of at least 3.75 x 9 mm. All patients will receive Titamax IT Cortical implants (Neodent, Curitiba, Brasil) and correspondent prosthodontic components - O'ring/ball abutments for overdentures. Satisfaction with the dentures and oral health-related quality of life impacts will be considered the measures of effectiveness for the three interventions. Cost assessment and cost-effectiveness analysis will be performed from the healthcare provider perspective. Further analysis will be performed using the patient's perspective, in which the costs will be estimated according to the reference price of dental procedures and treatments of the Brazilian Dental Association (Hierarchical Brazilian Classification of Dental Procedures - CBHPO) and the gross costs will be obtained from a panel of experts. Quantification and costing of the resources will be carried out in three steps: identification of the relevant costs to the assessment; measurement of the resources used; and valuation of the resources. The costs will be calculated in Brazilian currency for each patient until one year after treatment. Incremental cost-effectiveness ratios will be calculated to assess the incremental cost for each unit of effectiveness.
- Conditions
- Edentulous Mouth
- Being tested
- Single-implant mandibular overdenture, Two-implant mandibular overdenture, Fixed mandibular denture
- Keywords
- Overdenture, Dental implant, Complete denture, Cost analysis
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-implant mandibular overdentureDevice
Also called Single-implant overdenture
Complete mandibular denture retained by a single midline implant
Two-implant mandibular overdentureDevice
Also called 2-implant overdenture
Complete mandibular denture retained by two implants in the canine region
Fixed mandibular dentureDevice
Also called Full-arch mandibular prothesis
A fixed mandibular denture retained by four implants
| Study group | Role | What they receive |
|---|---|---|
| Single-implant mandibular overdenture | Experimental | A single midline implant and an O'ring/ball attachment to retain a mandibular overdenture Receives: Device: Single-implant mandibular overdenture |
| Two-implant mandibular overdenture | Experimental | Two implants in the canine region and two O'ring/ball attachments to retain a mandibular overdenture Receives: Device: Two-implant mandibular overdenture |
| Fixed mandibular denture | Experimental | A fixed four-implant mandibular denture Receives: Device: Fixed mandibular denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the dentures
A 10 cm uninterrupted visual analogue scale will be used in order to assess the participants' ratings of their satisfaction with the upper and lower dentures in relation to the parameters "general satisfaction", "comfort", "stability", "aesthetics", "ability to speak" and "ability to chew".
Measured: 1-year
Oral health-related quality of life impacts
Oral Health Impact Profile Instrument for edentulous subjects (OHIP-EDENT) in order to assess the impact of oral health conditions on quality of life of participants.
Measured: 1-year
Secondary outcomes (2)
Masticatory efficiency
Masticatory efficiency will be assessed as a secondary outcome using a two-colored chewing gum test and a qualitative and quantitative colourimetric method to measure the color-mixing ability.
Measured: 1-year
Cost
Direct and indirect treatment costs
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startJul 2016
- Primary completionJun 2019
- Study completionJun 2019
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 Edentulous MouthStudies 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
- Model description
- Comparative effectiveness of thre competing strategies for the edentulous mandible using implants
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cláudio Rodrigues Leles, Universidade Federal de Goias
- Investigators
- Enilza Paiva, PhD, Study chair, Dean of the Dental School, Federal University of Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056976
- Sponsor's protocol ID
- UFG_SAP_41429
- Acronym
- CEAIMPLANT
- Status last verified
- Apr 2020
- First submitted
- 14 Feb 2017
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nogueira TE, Esfandiari S, Leles CR. Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial. Trials. 2016 Nov 4;17(1):533. doi: 10.1186/s13063-016-1646-0.
PubMed 27814749
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Implant Treatment for the Edentulous Mandible
- ClinicalTrials.gov ID
- NCT03056976
- Acronym / sponsor ID
- CEAIMPLANT / UFG_SAP_41429
- Conditions
- Edentulous Mouth
- Keywords
- Overdenture, Dental implant, Complete denture, Cost analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 17 Feb 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.
The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants and the mandibular fixed prosthesis retained by four implants, based on a randomized clinical trial.
Detailed description
This randomized clinical trial alongside a cost-effectiveness analysis will include 48 edentulous individuals who meet eligibility criteria. Participants will receive conventional complete denture treatment and will be randomized into three groups: single-implant mandibular overdenture group, mandibular overdenture retained by two implants, and fixed mandibular prosthodontics retained by four implants. CBCT and panoramic radiographs will be obtained to assess if bone sites in three-dimensional terms have a minimum volume for receiving implants of at least 3.75 x 9 mm. All patients will receive Titamax IT Cortical implants (Neodent, Curitiba, Brasil) and correspondent prosthodontic components - O'ring/ball abutments for overdentures. Satisfaction with the dentures and oral health-related quality of life impacts will be considered the measures of effectiveness for the three interventions. Cost assessment and cost-effectiveness analysis will be performed from the healthcare provider perspective. Further analysis will be performed using the patient's perspective, in which the costs will be estimated according to the reference price of dental procedures and treatments of the Brazilian Dental Association (Hierarchical Brazilian Classification of Dental Procedures - CBHPO) and the gross costs will be obtained from a panel of experts. Quantification and costing of the resources will be carried out in three steps: identification of the relevant costs to the assessment; measurement of the resources used; and valuation of the resources. The costs will be calculated in Brazilian currency for each patient until one year after treatment. Incremental cost-effectiveness ratios will be calculated to assess the incremental cost for each unit of effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparative effectiveness of thre competing strategies for the edentulous mandible using implants
| Arm | Type | Receives |
|---|---|---|
| Single-implant mandibular overdenture | Experimental | Device: Single-implant mandibular overdentureA single midline implant and an O'ring/ball attachment to retain a mandibular overdenture |
| Two-implant mandibular overdenture | Experimental | Device: Two-implant mandibular overdentureTwo implants in the canine region and two O'ring/ball attachments to retain a mandibular overdenture |
| Fixed mandibular denture | Experimental | Device: Fixed mandibular dentureA fixed four-implant mandibular denture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- No contraindications for implant surgery (mainly related to uncontrolled systemic diseases)
- Present enough bone volume in the mandible for implant placement without the need of bone augmentation procedures.
- Be able to understand and answer the questionnaires used in the study
- Agree to participate by providing a written informed consent.
Key exclusion criteria (3 listed)
- Noncompliant participants
- Individuals who do not agree to be randomly allocated to the treatment study group
- Presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments
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 |
|---|---|---|
| Single-implant mandibular overdentureAlso: Single-implant overdentureComplete mandibular denture retained by a single midline implant | Device | Single-implant mandibular overdenture |
| Two-implant mandibular overdentureAlso: 2-implant overdentureComplete mandibular denture retained by two implants in the canine region | Device | Two-implant mandibular overdenture |
| Fixed mandibular dentureAlso: Full-arch mandibular prothesisA fixed mandibular denture retained by four implants | Device | Fixed mandibular denture |
Primary outcome
Satisfaction with the dentures
Time frame: 1-year
A 10 cm uninterrupted visual analogue scale will be used in order to assess the participants' ratings of their satisfaction with the upper and lower dentures in relation to the parameters "general satisfaction", "comfort", "stability", "aesthetics", "ability to speak" and "ability to chew".
Oral health-related quality of life impacts
Time frame: 1-year
Oral Health Impact Profile Instrument for edentulous subjects (OHIP-EDENT) in order to assess the impact of oral health conditions on quality of life of participants.
2 secondary outcomes
Masticatory efficiency
Time frame: 1-year
Cost
Time frame: 1-year
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 16 Apr 2020.
- Background: PubMed 27814749Nogueira TE, Esfandiari S, Leles CR. Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial. Trials. 2016 Nov 4;17(1):533. doi: 10.1186/s13063-016-1646-0.
- Individual participant dataSharing planned: No
Related trials for Edentulous Mouth
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Active, not recruiting
Clinical Evaluation of a New Printable Denture Base Material
Edentulous Mouth
Recruiting
Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
Edentulous Complete Denture Wearers
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
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.
Enilza Paiva, PhD study chair
Dean of the Dental School, Federal University of Goias
Questions about this trial
What is this clinical trial studying?
A study testing Single-implant mandibular overdenture, Two-implant mandibular overdenture and Fixed mandibular denture in people with Edentulous Mouth, run by Universidade Federal de Goias.
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 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 16 Apr 2020. 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?
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?
Satisfaction with the dentures (time frame: 1-year). The study lists 2 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 NCT03056976, 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 16 Apr 2020.