Peri-implant Tissues in BLX® Implants

N/ACompletedNCT03720236

University of Santiago de Compostela40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dental Implant Failed Dental Prosthesis Failure

Interventions

Implant bed preparation protocolPROCEDURE

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

Implant loadingPROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, Spain

Outcomes

Primary Outcomes

Primary stability of implants and peri-implant tissues

Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol (n = 20) and with the preparation protocol with under-fresh (n = 20). We will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ

Time frame: 12 months

Secondary Outcomes

Basal Peri-implant tissue level: implant stability

Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol (n = 20) and with the preparation protocol with under-fresh (n = 20). We will load the crowns in two different groups, code 1: loading the implants before 7 days after surgery; code 2: before 8 weeks after implant surgery. We will evaluate the stability at different moments, 8 weeks, 6 months and 12 months.The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ. ISQ values are obtained using resonance frequency analysis (RFA).

Time frame: 1 day

Basal Radiological Bone Implant level

At the moment of placing the implant a periapical radiography will be performed, considering this measure the basal radiological bone level (distance from the neck of the implant to the most crestal level of the alveolar bone). We will calculate the difference between the basal measure and the future measurements.

Time frame: 1 day

Basal Peri-implant tissue level: probing depth

Data from ClinicalTrials.gov

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