A Randomised, Controlled, Clinical Trial of Conventional and Immediately Loaded Tapered Implants, With Screw-Retained Crowns.

A Randomised, Controlled, Clinical Trial of Conventional and Immediately Loaded Tapered Implants, With Screw-Retained Crowns to Resolve Single Tooth Loss.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000655640

Enrollment

Registered

2005-10-18

Start date

2004-02-11

Completion date

Unknown

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

To compare surgical, prosthodontic, and patient outcomes of conventional and immediately loaded, single, tapered implants restored with screw-retained crowns in the anterior maxilla.

Interventions

Placement of single oral implants in the upper jaw to support single implant crowns for 5 years.

Study design

Allocation

Randomised controlled trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Able to understand and sign the informed consent form prior to starting of the study. 2) Able and willing to comply with all study requirements. 3) Adequate oral hygiene. 4) Adequate bone volume to accommodate the implant (implant lengths of 10-15mm; diameter of 2.5-4.0mm). 5) Good bone quality (class I-III) at the implant recipient site by radiographic assessment (Lekholm & Zarb 1985). 6) Recipient site for single implant in the anterior maxilla (Zone 1 or anterior portion of Zone 2). Patient may have one or two sites. Each site must have teeth mesial and distal to it. 7) Intention to be a long-term (minimum 5 years) resident of the Otago region, New Zealand. Able to participate in the trial and attend annual recalls.

Exclusion criteria

1) Heavy smoking or tobacco chewing2) History of alcoholism or drug abuse3) Severe bruxism or clenching habits4) Physical and/or mental disabilities, which will interfere with the maintenance of the implants5) Previous history of failed implant6) History of radiation treatment to the head and neck7) Undergoing chemotherapy8) Long-term therapy with steroids, immunosuppressants or biphosphates9) Insulin dependent and uncontrolled adult onset diabetic patients10) Chronic renal or liver disease11) Systemic and local bone disorders and pathology12) Serious cardiac and pulmonary disorders13) Haematological disorders14) High risk of developing bacterial endocarditis15) Immuno-compromised patient including HIV-positive16) Untreated periodontitis.

Outcome results