CClinicalTrials.gg
Sign In
CompletedNCT01411683Updated Apr 17, 2017

Mandibular Overdentures Retained by Conventional or Mini Implants

An interventional study of Implant-retained mandibular overdenture in Edentulous Mouth and Edentulous Jaw, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2017-04-17.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study 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. We will also evaluate post surgical discomfort, the success rate of prostheses and implants in the long term, denture quality and costs.

02

Conditions studied

  • Edentulous Mouth
  • Edentulous Jaw

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
03

In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's enrollment of 120 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    4 mini dental implants

    Retention of an overdenture by means of 4 mini implants.

    Device: Implant-retained mandibular overdenture

  • Experimental
    2 mini dental implants

    Retention of an overdenture by means of 2 mini implants.

    Device: Implant-retained mandibular overdenture

  • Active comparator
    2 conventional dental implants

    Retention of an overdenture by means of 2 conventional implants associated to ball attachments.

    Device: Implant-retained mandibular overdenture

Interventions

  • DeviceImplant-retained mandibular 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.

    Also known as: - Mini-implant overdenture.

06

What researchers measure

Primary outcomes

  1. Denture satisfaction

    To be assessed by specific questionnaires

    Time frame: 2 years

  2. Oral health-related quality of life

    To be assessed by means of the Brazilian version of the OHIP-EDENT.

    Time frame: 2 years

Secondary outcomes

  1. Post-surgical discomfort

    Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.

    Time frame: 7 days

  2. Success rate of implant-retained mandibular overdentures

    Survival of implant-retained overdentures.

    Time frame: 2 years

  3. Denture quality

    Functional aspects of mandibular overdentures, as assessed by a dentist.

    Time frame: 2 years

  4. 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.

    Time frame: 2 years

07

Study locations

1 site
  • Ribeirão Preto Dental School
    Ribeirão Preto, São Paulo 14040-904, Brazil
08

References and documents

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 27479342 ↗
  • Ribeiro 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 25765784 ↗
  • de 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 26294416 ↗
  • dos 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 24975725 ↗
  • Della 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01411683
Lead sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Raphael Freitas de Souza (Associate Professor, University of Sao Paulo) — Principal investigator
First posted
Aug 8, 2011
Start date
Sep 2011
Primary completion
Dec 2014
Completion
Apr 2017
Last update
Apr 17, 2017

Study contacts

Raphael F de Souza, DDS, PhD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Jaw, Edentulous→

Other studies from this sponsor

University of Sao Paulo

Start the discussion