NCT04043286

The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels

The Effects of Disconnection and Reconnection of Definitive Abutments on Peri-Implant Bone Levels: A 1-year Split-Mouth Randomized Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to evaluate the effects of definitive abutment connection at the time of implant placement on peri-implant bone levels and soft tissue changes in posterior maxilla and mandible regions.

Detailed description

A total of 38 implants were placed in 17 patients with at least 2 missing posterior teeth in the maxilla or the mandible for this study. Each patient received 2 or 4 implants. A definitive prefabricated abutment (test group) was randomly connected to one implant at implant placement (T0) and left undisturbed throughout the duration of the study. On the other implant, a healing abutment (control group) was connected and subjected to go through three disconnections and reconnections at 3 months (T3), 6 months (T6), and 12 months (T12) after the implant placement. Throughout the study period (1 year), all implants remained unrestored. Marginal bone level changes (MBLC) were assessed using standardized periapical radiographs taken at T0 and T12. Peri-implant soft tissue parameters including the keratinized mucosa width and lingual mucosa thickness were also recorded and evaluated.

Conditions

• Bone Loss
• Implant Complication
• Gingival Recession

Interventions

Type	Name	Description
DEVICE	Definitive abutment	With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures

Timeline

• Start date: 2019-09-30
• Primary completion: 2023-09-18
• Completion: 2023-09-18
• First posted: 2019-08-02
• Last updated: 2024-12-04
• Results posted: 2024-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study