Attachment Types for Single-implant Mandibular Overdentures: a Crossover Clinical Trial

NCT03048812 | Completed DMC

• 1 other identifier: UFG_43585
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dental implants are often the preferred treatment option and in some clinical scenarios they are considered the standard of care to restore missing or damaged teeth, due to the limitations of conventional treatments. For fully edentulous subjects, conventional tissue-supported dentures in some cases are associated with severe subjective complaints and difficult adaptation, mainly the mandibular denture, resulting in limited function and detrimental effects on oral health-related quality of life, especially for older patients. The use of implants to retain a mandibular denture (overdenture) has been recommended as a suitable and low-cost alternative to improve denture stability, with positive effects on oral comfort and function. The two-implant mandibular overdenture has been considered an effective design to achieve clinical benefits for patients. However, the main problem facing two-implant overdenture is the high cost of implantation and the relative complexity of the surgical intervention, so the use of a single midline implant to retain a mandibular overdenture was suggested as a more viable solution for reducing costs and complexity of treatment with similar benefits compared to solutions with higher number of implants. Nevertheless, there are few studies that compared the performance of different retention systems and their effects on patient-centered outcomes, such as satisfaction with the dentures, oral health-related quality of life, individual preferences and other subjective ratings of clinical outcomes. Thus, the aim of this randomized clinical trial with a crossover design is to investigate the changes in clinical and patient-reported outcomes following the use of different retention systems for a single implant-retained mandibular overdenture Hypothesis: it was hypothesized that clinical and patient-reported outcomes of a single-implant mandibular overdenture is dependent on the type of retention system, and patients have distinct preferences in relation to different attachments

Conditions

Edentulous Mouth; Complete Edentulism

Keywords

Dental implant; Mandibular overdenture; Cross-over study

Outcome Measures

Primary Outcomes (1)

• Patient preference

  Patient satisfaction with the attachment connected to the single implant overdenture

  3 months

Secondary Outcomes (3)

• Abutment loosening incidence

  3 months

• Patient satisfaction

  3 months

• Need for replacement

  3 months

Study Arms (2)

O'Ring attachment (A)

EXPERIMENTAL

One arm of our research will receive O'Ring attachment for 3 months and after this period they will recieve the second attachment Equator for more 3 months

Device: O'Ring Attachment (A); Device: Equator Attachment (B)

Equator attachment (B)

EXPERIMENTAL

The second arm of our research will receive Equator attachment for 3 months and after this period they will recieve the second attachement O Ring for more 3 months

Device: O'Ring Attachment (A); Device: Equator Attachment (B)

Interventions

O'Ring Attachment (A) DEVICE

Attachment A will be inserted in three months of follow up,followed by treatment B in a random order

Also known as: O'ring (Neodent, Curitiba, Paraná, Brazil)

Equator attachment (B); O'Ring attachment (A)

Equator Attachment (B) DEVICE

Attachment B will be inserted in three months of follow up,followed by treatment A in a random order

Also known as: Equator (Neodent, Curitiba, Paraná, Brazil)

Equator attachment (B); O'Ring attachment (A)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be completely edentulous, male or female with no age restrictions;
• Need replacement or confection of new complete dentures defined according to normative criteria and/or own demand;
• Have no contraindications for implant placement surgery (mainly related to uncontrolled systemic diseases such as diabetes and hypertension);
• Have enough bone volume in the mandibular midline area for installation of an implant without the need for augmentation procedures;
• be able to understand and answer to the questionnaires used in the study;
• agree to participate in this study by providing a written informed consent.

You may not qualify if:

• present signs that they will be uncompliant in the follow-up appointments;
• present local conditions that could directly influence stability and/or retention of the dentures

Sponsors & Collaborators

• Universidade Federal de Goias: lead

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Claudio R Leles, Doctorate

  UFG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessment will be blinded for assessment which treatment (O-Ring \\Equator) is provided
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are randomized to the AB sequence receive treatment A in the first period and treatment B in the second period, whereas experimental units that are randomized to the BA sequence receive treatment B in the first period and treatment A in the second period

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 9, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share