Non-invasive Solution for Periodontal and Peri-implant Diseases (INPERIO)

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 2, 2019

Primary Completion Date

July 4, 2022

Study Completion Date

July 4, 2022

Conditions
Peri-Implantitis
Interventions
DEVICE

Zirconia implants with G3-coated abutments (test implants and abutments)

"Test and control interventions correspond to those usually applied in dental implantology. The two-step protocol will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected."

DEVICE

Zirconia implants with control abutments (test implants, negative control abutments)

"Test and control interventions correspond to those usually applied in dental implantology. The two-step protocol will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected."

DEVICE

Titanium implants with G3-coated abutments (control implants, test abutments)

"Test and control interventions correspond to those usually applied in dental implantology. The two-step protocol will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected."

DEVICE

Titanium implants with control abutments (negative control implants and abutments)

"Test and control interventions correspond to those usually applied in dental implantology. The two-step protocol will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected."

DEVICE

Zirconia implants and titanium implants, for histological and histomorphometric evaluation.

"6 implants (3 tests and 3 controls) will be used to evaluate and compare osseointegration, via histological and histomorphometrical analysis, in the area of the wisdom teeth (non useful sites that will not interfere with the rest of the study or the patient's life) - it can only be performed in patients who no longer have these teeth. The procedure will match that described for Groups A-B-C-D. In this case, implants will only remain in the mouth for 2 months, after which they will be removed for analysis. The extraction will be performed with local anesthesia. A flap will be raised to expose the implant and, using a trephine bur (1 mm wider than the implant diameter), a bone cylinder containing the implant will be extracted. The resulting bone defect and regeneration process will be similar to those following a normal molar extraction. The flap will be sutured and primary curing is expected. A new implantation will not be carried out since in this area it is totally unnecessary."

Trial Locations (1)

28232

ICOA Noroeste SLP, Las Rozas de Madrid

All Listed Sponsors
collaborator

Horizon 2020 - European Commission

OTHER

collaborator

ICOA Noroeste SLP

UNKNOWN

collaborator

National Research Council, Spain

OTHER_GOV

collaborator

Experior

INDUSTRY

lead

Nanoker Research S.L.

INDUSTRY