A multicentre prospective evaluation of mandibular bilateral distal extension removable partial dentures, supported by ITI dental implants.

A Randomized Controlled Clinical Trial using Mandibular Bilateral Distal Extension Removable Implant Partial Dentures to Resolve Partial Tooth Loss.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000652673

Enrollment

Registered

2005-10-18

Start date

2004-11-15

Completion date

2006-12-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A multicentre study in New Zealand, Colombia and the Netherlands to evaluate the outcomes of removable partial dentures (plates) supported by oral implants

Interventions

Intervention group receives the placement of 2 oral implants to support the removal partial dentures in the mandible.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. be categorised as being in one of three categories of patient edentulism (Class I, II or III) as defined by the American College of Prosthodontists (McGarry et al. 2002).2. an edentulous maxilla, and a Kennedy Classification I mandibular arch with healthy periodontal tissues around the natural teeth. They should be having difficulty wearing their existing mandibular partial denture opposing the maxillary complete denture; exacerbated with on-going residual ridge resorption. 3. With sufficient bone volume in the posterior mandible to receive two implants of at least 8-10mm in length and 4.1mm in diameter; 4. having suitable bone quality as assessed radiographically (Lekholm & Zarb 1985). 5. have sufficient bone volume to fulfil one of the Cawood & Howell (1988) residual ridge classifications, except Class VI.

Exclusion criteria

1. patients with a Class IV category of American College of Prosthodontists classification of partial edentulism (McGarry et al. 2002).2. physical and mental disabilities which interfere with the maintenance of implants or removal of the RPD's.

Outcome results