NCT04343066

Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Saint-Joseph University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.

Detailed description

This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest. Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4. A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method. The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement. The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.

Conditions

• Dental Implantation
• Bone Remodeling

Interventions

Type	Name	Description
DEVICE	Implant insertion	In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites. A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement. Random allocation of implant type per site will be done by the sealed envelope method. Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process. Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking \< 10 cigarettes, previous horizontal bone augmentation, FMBS \<20% and FMPS \< 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.

Timeline

• Start date: 2019-04-15
• Primary completion: 2019-11-30
• Completion: 2020-12-30
• First posted: 2020-04-13
• Last updated: 2020-10-23

Locations

1 site across 1 country: Lebanon

Regulatory

• FDA-regulated device study