Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture

NCT03463174 | Completed DMC

• 1 other identifier: UFG_020_12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular overdenture.

Conditions

Mouth, Edentulous; Complete Edentulism

Keywords

overdenture; edentulism; dental implant; cost-effectiveness; economic analysis; effectiveness

Outcome Measures

Primary Outcomes (1)

• Oral health-related quality of life (OHRQoL)

  The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.

  From baseline to 12 months after the intervention

Secondary Outcomes (1)

• Satisfaction with the dentures

  From baseline to 12 months after the intervention

Other Outcomes (1)

• Costs

  From denture's fabrication to 12 months after the intervention

Study Arms (2)

Single-implant mandibular overdenture

EXPERIMENTAL

Participants allocated to this group will have a dental implant placed in the mandibular midline followed by the immediately insertion of a ball attachment and the incorporation of a retention matrix to the mandibular denture.

Procedure: Mandibular overdenture

Mandibular complete denture

ACTIVE COMPARATOR

Participants allocated to this group will not receive any additional treatment besides the new set of conventional complete dentures. When needed, retreatment or any adjustment/repair in the dentures will be performed accordingly. Participants will receive regular maintenance for their dentures, including adjustments for the elimination of sore areas, denture relining and repair of fractures, when needed, until the end of the follow-up period.

Other: Mandibular complete denture

Interventions

Mandibular overdenture PROCEDURE

Placement of an implant in the mandibular midline.

Also known as: Dental Implant (Straumann StandardPlus SLActive® RN implant)

Single-implant mandibular overdenture

Mandibular complete denture OTHER

No intervention.

Also known as: Complete denture

Mandibular complete denture

Eligibility Criteria

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

You may qualify if:

• To present favorable general health and the need to be rehabilitated with a new set of complete dentures
• To agree to be randomly assigned to one of the two study groups
• To be able to comprehend and answer the data collection instruments.

You may not qualify if:

• Presence of general health conditions that may contraindicate implant surgery (such as uncontrolled type II diabetes mellitus or uncontrolled cardiovascular conditions)
• Insufficient height and volume in the midline region to receive an implant of at least 3.75mm x 9.0mm
• Presence of evident signs of cognitive impairment and/or oral conditions requiring additional treatments, such as oral lesions and temporomandibular disorders
• Inability to attend to the scheduled appointments and follow-up visits

Sponsors & Collaborators

• Universidade Federal de Goias: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

School of Dentistry, Federal University of Goias

Goiânia, Goiás, 74605-220, Brazil

Location

Related Publications (1)

• Nogueira TE, Aguiar FMO, Esfandiari S, Leles CR. Effectiveness of immediately loaded single-implant mandibular overdentures versus mandibular complete dentures: A 1-year follow-up of a randomized clinical trial. J Dent. 2018 Oct;77:43-50. doi: 10.1016/j.jdent.2018.07.006. Epub 2018 Jul 10.

  PMID: 30006117 DERIVED

MeSH Terms

Conditions

Mouth, Edentulous

Interventions

Dental Implants; Denture, Complete

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Dentures

Study Officials

• Claudio R Leles, DDS, PhD

  Universidade Federal de Goias

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 13, 2018
• Study Start: March 10, 2015
• Primary Completion: September 20, 2017
• Study Completion: October 31, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

BR (1)