Peri-implant Tissues in BLX® Implants

NCT ID: NCT03720236

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-02
• Study Completion Date: 2020-06-19

Brief Summary

This is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in BLX implants loaded early or delayed and with different surgical milling protocols. To this end, 40 BLX implants with a diameter of 3.75x10 will be placed in areas of mature bone scarred after extraction. They will be divided into 2 study groups, and these in turn into two subgroups. Group A: complete milling, Group B: partial milling. Each group will be assigned with code 1: early load and code 2: deferred load. Clinical and radiological parameters will be evaluated.

Conditions

Dental Implant Failed; Dental Prosthesis Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Full preparation

Group A: the complete milling protocol indicated by the manufacturer for the 3.75x10 mm BLX implant will be performed.

Group Type: EXPERIMENTAL

Implant bed preparation protocol

Intervention Type: PROCEDURE

This is the first surgical phase, we prepare the implant bed by using different increasing size drills.

Partial preparation

Group B: the partial / under milling protocol for the 3.75x10 mm implant, indicated by the manufacturer, will be carried out.

Group Type: EXPERIMENTAL

Implant bed preparation protocol

Intervention Type: PROCEDURE

This is the first surgical phase, we prepare the implant bed by using different increasing size drills.

Deferred loading

Code 2: for implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. Impressions will be taken at 6 weeks to place the provisional prosthesis at 8 weeks. At 6 months the final impressions will be taken for the definitive load.

Group Type: EXPERIMENTAL

Implant loading

Intervention Type: PROCEDURE

This is the second phase, based on prosthetic procedures, to design the crown over the dental implant

Immediate load

The code 1: to the implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. The impression will be made in the same surgery and the placement of the provisional prosthesis before 7 days. At 6 months the final impressions will be taken for the definitive load.

Group Type: EXPERIMENTAL

Implant loading

Intervention Type: PROCEDURE

This is the second phase, based on prosthetic procedures, to design the crown over the dental implant

Interventions

Implant bed preparation protocol

This is the first surgical phase, we prepare the implant bed by using different increasing size drills.

Intervention Type: PROCEDURE

Implant loading

This is the second phase, based on prosthetic procedures, to design the crown over the dental implant

Intervention Type: PROCEDURE

Other Intervention Names

IBP; IL

Eligibility Criteria

Inclusion Criteria

• Patients without systemic pathology
• Adult of age who agree to be part of the study and sign the informed consent.
• Patients smoking less than 5 cigarettes / day,
• Patients not being completely edentulous
• Unitary / multiple absences in the area posterior with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques
• Area of mature bone healed at least 6 months post-extraction.
• The minimum torque for early loading will be 25 N. The placement of the implant will be mechanical up to 40 N maximum and manually finished with a surgical dynamometer.
• The placement of the abutment will be at a minimum of 25 N, in case the primary stability of the implant allows it, it will be placed at 35 N.
• The placement of the implant must always be 4 mm below the future gingival margi

Exclusion Criteria

• Immunosuppressed patients
• Aesthetic edentulous areas of 13-23 and 33-43
• Smokers of more than 5 cigarettes
• Implants with a lower torque whose will be submerged with a screw and a protocol will be followed in 2 phases, being discarded from the study.
• Index of bleeding greater than 30%
• Patients with less than 2 mm of keratinized gingiva
• Implants with ISQ index <55
• When a margin of 1 mm safety cannot be assumed to the inferior dental nerve

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Manohay Dental SAU

UNKNOWN

Sponsor Role: collaborator

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Mario Pérez Sayáns

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mario Perez Sayans, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Santiago de Compostela

Locations

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, Spain

Countries

Spain

Related Links

http://imaisd.usc.es/grupoficha.asp?idpersoatipogrupo=75189&i=es&s=-2-26-148

GI-1319

Other Identifiers

CT-2018-05

Identifier Type: -

Identifier Source: org_study_id