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

Phase 1

Active, not recruiting

• Conditions: Partial tooth loss - partial edentulism; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12605000655640
• Lead Sponsor: Southern Implants, South Africa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified