Early loading of mandibular single implant overdentures using a novel implant and attachment system: A randomized controlled clinical trial with laboratory component

Active, not recruiting

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

• Registration Number: ACTRN12608000585325
• Lead Sponsor: Southern Implants

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Elderly edentulous patients with history of difficulties with their complete mandibular dentures and with minimum height and width of bone at the midline of the mandible to accommodate a 7X8 mm diameter implants

Exclusion Criteria

Any systemic or local condition contradictory to implant surgery; Bruxism, Irradiated or grafted jaws; Smoking > 10 cigarettes a day; Drug abuse; Un-willingness to attend regular recalls.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the surgical outcome (success) of using single midline implants to support mandibular overdentures for 1 year following early loading protocol at 6 weeks. The implant success will be measured according to the criteria prescribed by Albrektsson and Zarb (1998) which require marginal bone loss around the implant to be < than 1.0 mm in the first year and < than 0.2 mm every year after. This will be determined using standardized peri-apical radiographic procedures (Payne et al 2001).[Assessment of baseline bone level will be carried out at 6 weeks post-op when implants are loaded with the overdentures. The measurement will then be repeated 1 year later. Each participant will be subjected to one measurement annually. The marginal bone level measurements will be carried out using standardized peri-apical radiographs.]

Secondary Outcome Measures

Name	Time	Method
To determine the prosthodontic outcome of mandibular single implant overdentures following early loading protocol at 6 weeks. The prosthodontic outcome will be measured by recording all maintenance events that will be endured by the implant overdenture starting from baseline (6 weeks post-op) up to the end of first year of service. These maintenance events will be allocated to 1 of 12 different categories of following the proposal of Payne et al (2001). The outcome of the implant overdenture at the end of the first year of service (based on these categories) will then be assigned to 1 of 6 objectively defined outcome fields: Success, Survival, Unknown, Dead, Retreatment (repair), and Retreatment (replace) otherwise known as the Six-Field Protocol for Implant Overdentures (Payne et al, 2001).[The maintenance events recording will start from baseline (6 weeks post-op) which corresponds to the start of loading and continues all through and up to the end of the first year of service.]