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Completed

NCT Number: NCT01411683

Mandibular Overdentures Retained by Conventional or Mini Implants

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.

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Key information

Conditions

Edentulous Mouth Behavior Edentulous Jaw Health Behavior Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Patient Acceptance of Health Care Patient Satisfaction Stomatognathic Diseases Tooth Diseases Treatment Adherence and Compliance

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, 14040-904, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Implant-retained mandibular overdenture

Device

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.

Other names: - Mini-implant overdenture.

Primary outcomes

  1. Denture satisfaction

    Time frame: 2 years

    To be assessed by specific questionnaires

  2. Oral health-related quality of life

    Time frame: 2 years

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

Secondary outcomes

  1. Post-surgical discomfort

    Time frame: 7 days

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

  2. Success rate of implant-retained mandibular overdentures

    Time frame: 2 years

    Survival of implant-retained overdentures.

  3. Denture quality

    Time frame: 2 years

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

  4. Treatment costs

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial

Important dates

Study start
2011
Primary completion
2014
Study completion
2017
First posted
Aug 8, 2011
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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