Mouth, EdentulousSIMOECONNCT02710357
A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture Treatment
A study testing Mandibular Overdenture and Mandibular complete denture in people with Mouth, Edentulous, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by a single implant. The study hypothesis is that SIMO is more effective but more costly than the conventional denture, though this incremental cost is relatively low for the offered effectiveness in terms of clinical and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- Mandibular Overdenture and Mandibular complete denture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to 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 Any age
- All sexes
- Healthy volunteers accepted
- 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 mandibular midline area 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry, Federal University of Goias
Goiânia, Goiás, 74605-220
About this study
Official title: Single-implant Mandibular Overdenture or a Conventional Complete Denture? A Cost-effectiveness Analysis Alongside a Randomized Clinical Trial
The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by a single implant. The study hypothesis is that SIMO is more effective but more costly than the conventional denture, though this incremental cost is relatively low for the offered effectiveness in terms of clinical and patient-reported outcomes.
Read the detailed description
This randomized clinical trial alongside a cost-effectiveness analysis will include twenty-eight edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. Then, participants will be randomized into one of the treatment groups: conventional complete denture group or single-implant mandibular overdenture group. Each participant allocated to the overdenture group will then receive a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline. A healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. Then, a 3.4mm retentive titanium anchor abutment (Straumann 048.439, Institute Straumann AG, Basel, Switzerland) will be connected and tightened to 35 N.cm with a torque wrench. The matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment and patient-reported outcomes will be assessed. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.
- Conditions
- Mouth, Edentulous
- Being tested
- Mandibular Overdenture, Mandibular complete denture
- Keywords
- Mandibular Prosthesis Implantation, Prostheses and Implants, Denture, Complete, Lower
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular OverdentureProcedure or surgery
Also called Dental Implant (Straumann Standard Plus SLActive® RN implant
Placement of an implant in the mandibular midline.
Mandibular complete dentureProcedure or surgery
No intervention. Maintenance of the dentures will be done when needed.
| Study group | Role | What they receive |
|---|---|---|
| Mandibular complete denture | Active comparator | Participants allocated to this group will not receive any additional treatment. When needed, retreatment or any adjustment/repair in the dentures will be performed accordingly. Participants will receive regular maintenance for their dentures, including adjustments for the elimination of sore areas, denture relining and repair of fractures, when needed, until the end of the follow-up period. Receives: Procedure: Mandibular complete denture |
| Single-implant mandibular overdenture | Experimental | Participants allocated to this group will have an implant placed in the mandibular midline and after 4 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture. Receives: Procedure: Mandibular Overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health-related quality of life impacts
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Measured: Changes from baseline to 12 months after the intervention
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". Each participant will indicate their level of satisfaction with each parameter by marking a point along the scale, in which ends mean "unsatisfied" and "satisfied", as it is closer to the beginning or the end of the scale, respectively.
Measured: Changes from baseline to 12 months after the intervention
Secondary outcomes (1)
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. Participants will be asked to sit upright in a dental chair and to chew the gum on their preferred chewing side for 20 cycles. Visual and electronic analysis of the chewed gums samples will be done according to the classification proposed by Schimmel et al. Analysis will be made by two investigators blinded to the study groups and treatment stage. The software ViewGum (dHAL Software, Kifissia, Greece, www.dhal.com) will be used for electronic colourimetric analysis.
Measured: Changes from baseline to 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018
- Study completionJun 2018
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 Mouth, EdentulousStudies 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
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Principal investigator, Cláudio Rodrigues Leles, Universidade Federal de Goias
- Investigators
- Claudio R Leles, DDS, PhD, Study director, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710357
- Sponsor's protocol ID
- 966_2014
- Acronym
- SIMOECON
- Status last verified
- Sep 2018
- First submitted
- 11 Mar 2016
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-implant Mandibular Overdenture or a Conventional Complete Denture? A Cost-effectiveness Analysis Alongside a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02710357
- Acronym / sponsor ID
- SIMOECON / 966_2014
- Conditions
- Mouth, Edentulous
- Keywords
- Mandibular Prosthesis Implantation, Prostheses and Implants, Denture, Complete, Lower
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Mar 2016 (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 aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by a single implant. The study hypothesis is that SIMO is more effective but more costly than the conventional denture, though this incremental cost is relatively low for the offered effectiveness in terms of clinical and patient-reported outcomes.
Detailed description
This randomized clinical trial alongside a cost-effectiveness analysis will include twenty-eight edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. Then, participants will be randomized into one of the treatment groups: conventional complete denture group or single-implant mandibular overdenture group. Each participant allocated to the overdenture group will then receive a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline. A healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. Then, a 3.4mm retentive titanium anchor abutment (Straumann 048.439, Institute Straumann AG, Basel, Switzerland) will be connected and tightened to 35 N.cm with a torque wrench. The matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment and patient-reported outcomes will be assessed. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandibular complete denture | Active comparator | Procedure: Mandibular complete dentureParticipants allocated to this group will not receive any additional treatment. When needed, retreatment or any adjustment/repair in the dentures will be performed accordingly. Participants will receive regular maintenance for their dentures, including adjustments for the elimination of sore areas, denture relining and repair of fractures, when needed, until the end of the follow-up period. |
| Single-implant mandibular overdenture | Experimental | Procedure: Mandibular OverdentureParticipants allocated to this group will have an implant placed in the mandibular midline and after 4 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture. |
Who may qualify
- Sex
- All
- Healthy volunteers
- 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 mandibular midline area 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 |
|---|---|---|
| Mandibular OverdentureAlso: Dental Implant (Straumann Standard Plus SLActive® RN implantPlacement of an implant in the mandibular midline. | Procedure or surgery | Single-implant mandibular overdenture |
| Mandibular complete dentureNo intervention. Maintenance of the dentures will be done when needed. | Procedure or surgery | Mandibular complete denture |
Primary outcome
Oral health-related quality of life impacts
Time frame: Changes from baseline to 12 months after the intervention
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Satisfaction with the dentures
Time frame: Changes from baseline to 12 months after the intervention
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". Each participant will indicate their level of satisfaction with each parameter by marking a point along the scale, in which ends mean "unsatisfied" and "satisfied", as it is closer to the beginning or the end of the scale, respectively.
1 secondary outcome
Masticatory efficiency
Time frame: Changes from baseline to 12 months after the intervention
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 18 Sep 2018.
- Derived from this study: 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.
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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.
Claudio R Leles, DDS, PhD study director
Universidade Federal de Goias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Overdenture and Mandibular complete denture in people with Mouth, Edentulous, run by Universidade Federal de Goias 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 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 18 Sep 2018. 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?
Oral health-related quality of life impacts (time frame: Changes from baseline to 12 months after the intervention). 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 NCT02710357, 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 18 Sep 2018.