Edentulous MouthNCT01411683
Mandibular Overdentures Retained by Conventional or Mini Implants
A study testing Implant-retained mandibular overdenture in people with Edentulous Mouth and Edentulous Jaw, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to compare mandibular overdentures retained either by mini or standard size implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and oral health-related quality of life. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Edentulous Mouth, Edentulous Jaw
- What is being tested?
- Implant-retained mandibular overdenture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Apr 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complete edentulism;
- Request of implant stabilization of the existing lower conventional denture;
- Clinically acceptable maxillary and mandibular complete dentures;
- Adequate space in the anterior mandible for the placement of four mini implants and two conventional implants (regular diameter);
- Ability to maintain adequate oral hygiene and clean dentures;
- Systemic health status that permits minor surgical procedures;
- Adequate understanding of written and spoken Portuguese;
- Capacity of giving written informed consent.
Who cannot join
- Lack of minimum vertical mandibular bone height of 11mm in the interforaminal region;
- Acute or chronic symptoms of parafunctional disorders;
- History of radiation therapy to the orofacial region;
- Specific conditions that may jeopardize the treatment, i.e. alcoholism and smoking;
- Severe/serious illness that requires frequent hospitalization;
- Impaired cognitive function;
- Impossibility to return for evaluations/study recalls.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial
This study aims to compare mandibular overdentures retained either by mini or standard size implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and oral health-related quality of life. We will also evaluate post surgical discomfort, the success rate of prostheses and implants in the long term, denture quality and costs.
- Conditions
- Edentulous Mouth, Edentulous Jaw
- Being tested
- Implant-retained mandibular overdenture
- Keywords
- Cost estimates, Complete Denture, Dental Economics, Dental Implants, Dental Prosthesis, Implant-Supported, Denture Retention, Edentulous, Edentulism, Mini dental implant, Oral Health-Related Quality of Life, Overdenture, Patient Acceptance of Health Care, Quality of Health Care, Quality of Life, Patient Satisfaction
- Medical subject headings
- Mouth, Edentulous, Jaw, Edentulous, Patient Acceptance of Health Care, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant-retained mandibular overdentureDevice
Also called - Mini-implant overdenture.
Insertion of implants in the lower arch in order to retain existing complete dentures. Tested implants are approved by the Brazilian National Health Surveillance Agency for clinical use.
| Study group | Role | What they receive |
|---|---|---|
| 4 mini dental implants | Experimental | Retention of an overdenture by means of 4 mini implants. Receives: Device: Implant-retained mandibular overdenture |
| 2 mini dental implants | Experimental | Retention of an overdenture by means of 2 mini implants. Receives: Device: Implant-retained mandibular overdenture |
| 2 conventional dental implants | Active comparator | Retention of an overdenture by means of 2 conventional implants associated to ball attachments. Receives: Device: Implant-retained mandibular overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denture satisfaction
To be assessed by specific questionnaires
Measured: 2 years
Oral health-related quality of life
To be assessed by means of the Brazilian version of the OHIP-EDENT.
Measured: 2 years
Secondary outcomes (4)
Post-surgical discomfort
Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.
Measured: 7 days
Success rate of implant-retained mandibular overdentures
Survival of implant-retained overdentures.
Measured: 2 years
Denture quality
Functional aspects of mandibular overdentures, as assessed by a dentist.
Measured: 2 years
Treatment costs
This outcome will be measured by means of specific forms, according to 2 components:
- Direct costs: cost of labor, materials, radiographs and medications;
- Indirect costs: patient's time and transportation expenses.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2014
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Raphael Freitas de Souza, University of Sao Paulo
- Investigators
- Raphael F de Souza, DDS, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411683
- Sponsor's protocol ID
- FORP-PT-004
- Other IDs
- 2011.1.197.58.3, 2011/00688-7
- Status last verified
- Apr 2017
- First submitted
- 5 Aug 2011
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chaves CA, Souza RF, Cunha TR, Vecchia MP, Ribeiro AB, Bruniera JF, Silva-Sousa YT. Preliminary In Vitro Study on O-Ring Wear in Mini-Implant-Retained Overdentures. Int J Prosthodont. 2016 Jul-Aug;29(4):357-9. doi: 10.11607/ijp.4677.
PubMed 27479342Ribeiro AB, Della Vecchia MP, Cunha TR, Sorgini DB, Dos Reis AC, Muglia VA, de Albuquerque RF Jr, de Souza RF. Short-term post-operative pain and discomfort following insertion of mini-implants for retaining mandibular overdentures: a randomized controlled trial. J Oral Rehabil. 2015 Aug;42(8):605-14. doi: 10.1111/joor.12287. Epub 2015 Mar 13.
PubMed 25765784de Souza RF, Ribeiro AB, Della Vecchia MP, Costa L, Cunha TR, Reis AC, Albuquerque RF Jr. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial. J Dent Res. 2015 Oct;94(10):1376-84. doi: 10.1177/0022034515601959. Epub 2015 Aug 20.
PubMed 26294416dos Reis AC, Leon JE, Ribeiro AB, Della Vecchia MP, Cunha TR, de Souza RF. Traumatic ulcerative granuloma with stromal eosinophilia around mini dental implants without the protection of a denture base. J Prosthodont. 2015 Jan;24(1):83-6. doi: 10.1111/jopr.12184. Epub 2014 Jun 27.
PubMed 24975725Della Vecchia MP, Leles CR, Cunha TR, Ribeiro AB, Sorgini DB, Muglia VA, Reis AC, Albuquerque RF Jr, de Souza RF. Mini-Implants for Mandibular Overdentures: Cost-Effectiveness Analysis alongside a Randomized Trial. JDR Clin Trans Res. 2018 Jan;3(1):47-56. doi: 10.1177/2380084417741446. Epub 2017 Nov 20.
PubMed 30938654
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01411683
- Acronym / sponsor ID
- FORP-PT-004
- Conditions
- Edentulous Mouth, Edentulous Jaw
- Keywords
- Cost estimates, Complete Denture, Dental Economics, Dental Implants, Dental Prosthesis, Implant-Supported, Denture Retention, Edentulous, Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Aug 2011 (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 compare mandibular overdentures retained either by mini or standard size implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and oral health-related quality of life. We will also evaluate post surgical discomfort, the success rate of prostheses and implants in the long term, denture quality and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 mini dental implants | Experimental | Device: Implant-retained mandibular overdentureRetention of an overdenture by means of 4 mini implants. |
| 2 mini dental implants | Experimental | Device: Implant-retained mandibular overdentureRetention of an overdenture by means of 2 mini implants. |
| 2 conventional dental implants | Active comparator | Device: Implant-retained mandibular overdentureRetention of an overdenture by means of 2 conventional implants associated to ball attachments. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Complete edentulism;
- Request of implant stabilization of the existing lower conventional denture;
- Clinically acceptable maxillary and mandibular complete dentures;
- Adequate space in the anterior mandible for the placement of four mini implants and two conventional implants (regular diameter);
- Ability to maintain adequate oral hygiene and clean dentures;
Key exclusion criteria (7 listed)
- Lack of minimum vertical mandibular bone height of 11mm in the interforaminal region;
- Acute or chronic symptoms of parafunctional disorders;
- History of radiation therapy to the orofacial region;
- Specific conditions that may jeopardize the treatment, i.e. alcoholism and smoking;
- Severe/serious illness that requires frequent hospitalization;
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 |
|---|---|---|
| Implant-retained mandibular overdentureAlso: - Mini-implant overdenture.Insertion of implants in the lower arch in order to retain existing complete dentures. Tested implants are approved by the Brazilian National Health Surveillance Agency for clinical use. | Device | 2 conventional dental implants, 2 mini dental implants, 4 mini dental implants |
Primary outcome
Denture satisfaction
Time frame: 2 years
To be assessed by specific questionnaires
Oral health-related quality of life
Time frame: 2 years
To be assessed by means of the Brazilian version of the OHIP-EDENT.
4 secondary outcomes
Post-surgical discomfort
Time frame: 7 days
Success rate of implant-retained mandibular overdentures
Time frame: 2 years
Denture quality
Time frame: 2 years
Treatment costs
Time frame: 2 years
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 17 Apr 2017.
- Results publication: PubMed 27479342Chaves CA, Souza RF, Cunha TR, Vecchia MP, Ribeiro AB, Bruniera JF, Silva-Sousa YT. Preliminary In Vitro Study on O-Ring Wear in Mini-Implant-Retained Overdentures. Int J Prosthodont. 2016 Jul-Aug;29(4):357-9. doi: 10.11607/ijp.4677.
- Results publication: PubMed 25765784Ribeiro AB, Della Vecchia MP, Cunha TR, Sorgini DB, Dos Reis AC, Muglia VA, de Albuquerque RF Jr, de Souza RF. Short-term post-operative pain and discomfort following insertion of mini-implants for retaining mandibular overdentures: a randomized controlled trial. J Oral Rehabil. 2015 Aug;42(8):605-14. doi: 10.1111/joor.12287. Epub 2015 Mar 13.
- Results publication: PubMed 26294416de Souza RF, Ribeiro AB, Della Vecchia MP, Costa L, Cunha TR, Reis AC, Albuquerque RF Jr. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial. J Dent Res. 2015 Oct;94(10):1376-84. doi: 10.1177/0022034515601959. Epub 2015 Aug 20.
- Results publication: PubMed 24975725dos Reis AC, Leon JE, Ribeiro AB, Della Vecchia MP, Cunha TR, de Souza RF. Traumatic ulcerative granuloma with stromal eosinophilia around mini dental implants without the protection of a denture base. J Prosthodont. 2015 Jan;24(1):83-6. doi: 10.1111/jopr.12184. Epub 2014 Jun 27.
- Derived from this study: PubMed 30938654Della Vecchia MP, Leles CR, Cunha TR, Ribeiro AB, Sorgini DB, Muglia VA, Reis AC, Albuquerque RF Jr, de Souza RF. Mini-Implants for Mandibular Overdentures: Cost-Effectiveness Analysis alongside a Randomized Trial. JDR Clin Trans Res. 2018 Jan;3(1):47-56. doi: 10.1177/2380084417741446. Epub 2017 Nov 20.
- Institutional page of the Ribeirão Preto Dental School (research site)Link provided by the sponsor.
- Principal Investigator´s CV (RF de Souza)Link provided by the sponsor.
- Principal Investigator´s CV (RF Albuquerque Jr)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Edentulous Mouth
Not yet recruiting
Clinical and Radiographic Comparison of Two Implant-Abutment Connections
Dental Implant, Edentulous Alveolar Ridge
RecruitingObservational study
Assessing Current Clinical Concepts in Dental Practice
Dental Implant
Recruiting
Clinical Outcomes of 3D Printed and Milled Complete Dentures
Edentulous Mouth, Edentulous Jaw
RecruitingPhase 4
Clinical Performance of Nobel N1 System
Tooth Loss, Dental Implant
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
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.
Raphael F de Souza, DDS, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant-retained mandibular overdenture in people with Edentulous Mouth and Edentulous Jaw, run by University of Sao Paulo 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 8 inclusion and 7 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 17 Apr 2017. 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?
Denture satisfaction (time frame: 2 years). 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 NCT01411683, which also lists 5 linked publications.
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 17 Apr 2017; AzTrials last refreshed its copy on 27 Oct 2026.