Mouth, EdentulousNCT03463174
Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture
A study testing Mandibular overdenture and Mandibular complete denture in people with Mouth, Edentulous and Complete Edentulism, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
This is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular overdenture. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mouth, Edentulous, Complete Edentulism
- 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
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2015to 31 Oct 2017
- 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
- To present favorable general health and the need to be rehabilitated with a new set of complete dentures
- To agree to be randomly assigned to one of the two study groups
- To be able to comprehend and answer the data collection instruments.
Who cannot join
- Presence of general health conditions that may contraindicate implant surgery (such as uncontrolled type II diabetes mellitus or uncontrolled cardiovascular conditions)
- Insufficient height and volume in the midline region to receive an implant of at least 3.75mm x 9.0mm
- Presence of evident signs of cognitive impairment and/or oral conditions requiring additional treatments, such as oral lesions and temporomandibular disorders
- Inability to attend to the scheduled appointments and follow-up visits
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: A Randomized Controlled Clinical Trial Alongside a Cost-effectiveness Analysis of the Mandibular Conventional Complete Denture Versus Single-implant Mandibular Overdenture
This is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular overdenture.
Read the detailed description
This randomized clinical trial alongside a cost-effectiveness analysis will include 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 an implant (Titamax TI cortical - Neodent, Brazil) in the mandibular midline followed by the immediate connection of an O-Ring/ball attachment with intra-oral incorporation of the retention system in the mandibular denture. 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, Complete Edentulism
- Being tested
- Mandibular overdenture, Mandibular complete denture
- Keywords
- overdenture, edentulism, dental implant, cost-effectiveness, economic analysis, effectiveness
- 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 StandardPlus SLActive® RN implant)
Placement of an implant in the mandibular midline.
Mandibular complete dentureOther
Also called Complete denture
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Single-implant mandibular overdenture | Experimental | Participants allocated to this group will have a dental implant placed in the mandibular midline followed by the immediately insertion of a ball attachment and the incorporation of a retention matrix to the mandibular denture. Receives: Procedure: Mandibular overdenture |
| Mandibular complete denture | Active comparator | Participants allocated to this group will not receive any additional treatment besides the new set of conventional complete dentures. 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: Other: Mandibular complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health-related quality of life (OHRQoL)
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: From baseline to 12 months after the intervention
Secondary outcomes (1)
Satisfaction with the dentures
Participants will report how satisfied they are on a 0-100 scale by choosing a multiple of 10. Zero will be considered the least satisfied possible and "100" the most satisfied possible.
Measured: 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 posted13 Mar 2018
- Study start10 Mar 2015
- Primary completion20 Sep 2017
- Study completion31 Oct 2017
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- 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
- NCT03463174
- Sponsor's protocol ID
- UFG_020_12
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nogueira TE, Aguiar FMO, Esfandiari S, Leles CR. Effectiveness of immediately loaded single-implant mandibular overdentures versus mandibular complete dentures: A 1-year follow-up of a randomized clinical trial. J Dent. 2018 Oct;77:43-50. doi: 10.1016/j.jdent.2018.07.006. Epub 2018 Jul 10.
PubMed 30006117
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Alongside a Cost-effectiveness Analysis of the Mandibular Conventional Complete Denture Versus Single-implant Mandibular Overdenture
- ClinicalTrials.gov ID
- NCT03463174
- Acronym / sponsor ID
- UFG_020_12
- Conditions
- Mouth, Edentulous, Complete Edentulism
- Keywords
- overdenture, edentulism, dental implant, cost-effectiveness, economic analysis, effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 10 Mar 2015 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 13 Mar 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.
This is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular overdenture.
Detailed description
This randomized clinical trial alongside a cost-effectiveness analysis will include 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 an implant (Titamax TI cortical - Neodent, Brazil) in the mandibular midline followed by the immediate connection of an O-Ring/ball attachment with intra-oral incorporation of the retention system in the mandibular denture. 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 |
|---|---|---|
| Single-implant mandibular overdenture | Experimental | Procedure: Mandibular overdentureParticipants allocated to this group will have a dental implant placed in the mandibular midline followed by the immediately insertion of a ball attachment and the incorporation of a retention matrix to the mandibular denture. |
| Mandibular complete denture | Active comparator | Other: Mandibular complete dentureParticipants allocated to this group will not receive any additional treatment besides the new set of conventional complete dentures. 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- To present favorable general health and the need to be rehabilitated with a new set of complete dentures
- To agree to be randomly assigned to one of the two study groups
- To be able to comprehend and answer the data collection instruments.
Key exclusion criteria (4 listed)
- Presence of general health conditions that may contraindicate implant surgery (such as uncontrolled type II diabetes mellitus or uncontrolled cardiovascular conditions)
- Insufficient height and volume in the midline region to receive an implant of at least 3.75mm x 9.0mm
- Presence of evident signs of cognitive impairment and/or oral conditions requiring additional treatments, such as oral lesions and temporomandibular disorders
- Inability to attend to the scheduled appointments and follow-up visits
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 StandardPlus SLActive® RN implant)Placement of an implant in the mandibular midline. | Procedure or surgery | Single-implant mandibular overdenture |
| Mandibular complete dentureAlso: Complete dentureNo intervention. | Other | Mandibular complete denture |
Primary outcome
Oral health-related quality of life (OHRQoL)
Time frame: 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.
1 secondary outcome
Satisfaction with the dentures
Time frame: 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 13 Mar 2018.
- Derived from this study: PubMed 30006117Nogueira TE, Aguiar FMO, Esfandiari S, Leles CR. Effectiveness of immediately loaded single-implant mandibular overdentures versus mandibular complete dentures: A 1-year follow-up of a randomized clinical trial. J Dent. 2018 Oct;77:43-50. doi: 10.1016/j.jdent.2018.07.006. Epub 2018 Jul 10.
- Individual participant dataSharing planned: Undecided
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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 and Complete Edentulism, 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 3 inclusion and 4 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 13 Mar 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 (OHRQoL) (time frame: From baseline to 12 months after the intervention). 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 NCT03463174, 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 13 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.