Mouth, EdentulousSIOverNCT01801566
Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment
A study testing Single implant-retained mandibular overdenture in people with Mouth, Edentulous, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
This study aims to evaluate the treatment with single implant overdenture for the edentulous mandible. The investigators hypothesize that treatment with lower overdenture retained by a single implant appears to have satisfactory effectiveness as a treatment for patients with specific conditions (such as maladaptive… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- Single implant-retained mandibular overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Dec 2014
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully edentulous patients
- Need of replacement of the mandibular denture or patient without mandibular denture
- Patients with poor adaptation to the mandibular denture
- Patients with good general health
Who cannot join
- Patients who refuse to receive a conventional dentures opposed to a mandibular overdenture retained by a single implant
- Patients with local intraoral diseases that influence denture stability, retention and adaptation of the lower denture (such as changes or anatomical deformations of the jaws, mucosal changes caused by fungi and bacteria, tumor changes and absolute xerostomia)
- Patients with systemic, psychological or neurological diseases that preclude or hinder oral movements of the patient for clinical care and/or clinical follow-up in all stages of the research
- Patients who choose other treatment modalities not covered by the study
- Patients with alcoholism or other severe behavioral disorders that compromise their participation in the study
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: Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment: Radiographic Evaluations, Patient's Satisfaction, and Oral-health-related Quality of Life
This study aims to evaluate the treatment with single implant overdenture for the edentulous mandible. The investigators hypothesize that treatment with lower overdenture retained by a single implant appears to have satisfactory effectiveness as a treatment for patients with specific conditions (such as maladaptive patients), with the advantages of simplicity and greater immediate benefits when compared to the conventional full denture, improving the retention and stability of the denture and better oral-related quality of life.
Read the detailed description
This study is a longitudinal evaluation of clinical and patient-reported outcomes related to the single-implant mandibular overdenture treatment. Sixty completely edentulous individuals will be included. First, new complete dentures will be fabricated for all of them. Panoramic radiographs and conventional tomograms of the mandibular midline region will be obtained in order to plan the implant placement surgery. After the adaptation period related to the use of the new dentures, a single implant (Titamax IT Cortical, Neodent, Curitiba, Brazil) will be installed in the mandibular midline of all participants. According to the primary stability obtained in the implant placement patients will be treated with an immediate loading protocol when achieving torque of at least 30 Ncm and implant stability quotient (ISQ) of at least 60. In cases of values below cited, conventional loading protocol will be adopted. Ball O-ring will be used as the attachment system for the mandibular overdenture. Clinical and patient-reported outcomes will be collected after 1, 3, 6 and 12 months after the installation of the overdentures.
- Conditions
- Mouth, Edentulous
- Being tested
- Single implant-retained mandibular overdenture
- 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.
Single implant-retained mandibular overdentureProcedure or surgery
60 patients treated with single implant retained complete mandibular denture (overdenture) opposed to a conventional maxillary denture, allocated into 2 experimental groups according to the implant loading protocol (conventional and immediate), evaluated at baseline and after 1, 3, 6 and 12 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Conventional implant loading protocol | Active comparator | Single implant-retained mandibular overdenture Receives: Procedure: Single implant-retained mandibular overdenture |
| Immediate loading implant protocol | Experimental | Single implant-retained mandibular overdenture Receives: Procedure: Single implant-retained 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
Oral health related quality of life impacts were measured using the Brazilian version of the Oral Health Impact Profile for Edentulous subjects (Souza et al., 2007; Souza et al., 2010), considering the overall scale and its four different scale domains: masticatory discomfort and disability (four items), (2) psychological discomfort and disability (five items), social disability (five items) and oral pain and discomfort (five items).
Measured: Change from baseline on oral health-related quality of life impacts at 12 months
Secondary outcomes (1)
Satisfaction with dentures
Satisfaction with dentures measured using the patients' ratings of the overall satisfaction with the mandibular denture, and satisfaction with comfort, stability, esthetics, ability to speak, and ability to chew. All satisfaction items will be measured on a 10-point visual analogue scale ranging from 0 to 10
Measured: Change from baseline on satisfaction with dentures at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 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, Principal investigator, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801566
- Sponsor's protocol ID
- U1111-1129-9956
- Acronym
- SIOver
- Status last verified
- Mar 2016
- First submitted
- 25 Feb 2013
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment: Radiographic Evaluations, Patient's Satisfaction, and Oral-health-related Quality of Life
- ClinicalTrials.gov ID
- NCT01801566
- Acronym / sponsor ID
- SIOver / U1111-1129-9956
- Conditions
- Mouth, Edentulous
- Keywords
- Mandibular Prosthesis Implantation, Prostheses and Implants, Denture, Complete, Lower
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Mar 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.
This study aims to evaluate the treatment with single implant overdenture for the edentulous mandible. The investigators hypothesize that treatment with lower overdenture retained by a single implant appears to have satisfactory effectiveness as a treatment for patients with specific conditions (such as maladaptive patients), with the advantages of simplicity and greater immediate benefits when compared to the conventional full denture, improving the retention and stability of the denture and better oral-related quality of life.
Detailed description
This study is a longitudinal evaluation of clinical and patient-reported outcomes related to the single-implant mandibular overdenture treatment. Sixty completely edentulous individuals will be included. First, new complete dentures will be fabricated for all of them. Panoramic radiographs and conventional tomograms of the mandibular midline region will be obtained in order to plan the implant placement surgery. After the adaptation period related to the use of the new dentures, a single implant (Titamax IT Cortical, Neodent, Curitiba, Brazil) will be installed in the mandibular midline of all participants. According to the primary stability obtained in the implant placement patients will be treated with an immediate loading protocol when achieving torque of at least 30 Ncm and implant stability quotient (ISQ) of at least 60. In cases of values below cited, conventional loading protocol will be adopted. Ball O-ring will be used as the attachment system for the mandibular overdenture. Clinical and patient-reported outcomes will be collected after 1, 3, 6 and 12 months after the installation of the overdentures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional implant loading protocol | Active comparator | Procedure: Single implant-retained mandibular overdentureSingle implant-retained mandibular overdenture |
| Immediate loading implant protocol | Experimental | Procedure: Single implant-retained mandibular overdentureSingle implant-retained mandibular overdenture |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fully edentulous patients
- Need of replacement of the mandibular denture or patient without mandibular denture
- Patients with poor adaptation to the mandibular denture
- Patients with good general health
Key exclusion criteria (5 listed)
- Patients who refuse to receive a conventional dentures opposed to a mandibular overdenture retained by a single implant
- Patients with local intraoral diseases that influence denture stability, retention and adaptation of the lower denture (such as changes or anatomical deformations of the jaws, mucosal changes caused by fungi and bacteria, tumor changes and absolute xerostomia)
- Patients with systemic, psychological or neurological diseases that preclude or hinder oral movements of the patient for clinical care and/or clinical follow-up in all stages of the research
- Patients who choose other treatment modalities not covered by the study
- Patients with alcoholism or other severe behavioral disorders that compromise their participation in the study
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-retained mandibular overdenture60 patients treated with single implant retained complete mandibular denture (overdenture) opposed to a conventional maxillary denture, allocated into 2 experimental groups according to the implant loading protocol (conventional and immediate), evaluated at baseline and after 1, 3, 6 and 12 months after treatment. | Procedure or surgery | Conventional implant loading protocol, Immediate loading implant protocol |
Primary outcome
Oral health-related quality of life impacts
Time frame: Change from baseline on oral health-related quality of life impacts at 12 months
Oral health related quality of life impacts were measured using the Brazilian version of the Oral Health Impact Profile for Edentulous subjects (Souza et al., 2007; Souza et al., 2010), considering the overall scale and its four different scale domains: masticatory discomfort and disability (four items), (2) psychological discomfort and disability (five items), social disability (five items) and oral pain and discomfort (five items).
1 secondary outcome
Satisfaction with dentures
Time frame: Change from baseline on satisfaction with dentures at 12 months
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 Mar 2016.
- Website of the Main study sponsorLink provided by the sponsor.
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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 principal investigator
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 Single implant-retained mandibular overdenture 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 5 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 Mar 2016. 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: Change from baseline on oral health-related quality of life impacts at 12 months). 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 16 Mar 2016.