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

Saint-Joseph University

Status

Unknown

Conditions

Bone Remodeling

Dental Implantation

Treatments

Device: Implant insertion

Study type

Interventional

Funder types

Other

Identifiers

NCT04343066

FMD195

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient age: between 20 and 65
No systematic contraindication for implant surgery
No more than 10 cigarettes/day
Previous horizontal bone augmentation 6 months prior to implant placement
Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%)

Exclusion criteria

Smokers more than 10 cigarettes/day
Pregnant/lactating women
Alcoholics/drug addicts
Uncontrolled diabetics, immunocompromised, blood hemostasis problems
Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing
Patients not willing to sign the consent form
History of radiotherapy in the head and neck region in the last 5 years
Active periodontitis on the remaining teeth