Crestal vs Lateral Sinus Lift Augmentation

NCT ID: NCT04111250

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2019-04-02

Brief Summary

The aim of this randomised controlled trial (RCT) of split-mouth design was to compare patient preference and effectiveness of two different techniques for lifting the maxillary sinus: the crestal approach versus the lateral window approach.

Detailed Description

Each patient having bilateral edentulism in posterior maxillae was randomised to receive one partial fixed prosthesis supported by one to three implants placed either with a crestal or with lateral window sinus lift procedure.

Eligibility criteria for participants

Only healed implant sites were considered (at least 3 months after tooth extraction). The vertical bone height at the implant sites to be included had to be between 2 to 6 mm and bone thickness at least 6 mm as measured on cone-bean computed tomography (CBCT) scans.

Patients were not admitted in the study if any of the following exclusion criteria was present:

general contraindications to implant surgery subjected to irradiation in the head and neck area immunosuppressed or immunocompromised treated or under treatment with intravenous amino-bisphosphonates poor oral hygiene and motivation untreated periodontal disease uncontrolled diabetes pregnant or lactating substance abusers psychiatric problems unrealistic expectations lack of opposite occluding dentition/prosthesis in the area intended for implant placement acute or chronic infection/inflammation in the area intended for sinus augmentation/implant placement referred only for implant placement who cannot be rehabilitated and followed at the treatment centre unable to attend a 5-year post-loading follow-up. Smokers were included and patients were categorised into three groups according to what declare: i) non-smokers; ìì) moderate smokers, if smoking up to 10 cigarettes/day; iii) heavy smokers if smoking more than 10 cigarettes/day.

Patients were recruited and treated in one private practice in Tirana, Albania by two operators: Marco Tallarico who performed all surgical interventions and Erta Xhanari who performed all prosthetic and maintenance procedures.

Conditions

Edentulous Alveolar Ridge; Bone Atrophy, Alveolar

Study Design

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

Study Groups

Crestal sinus lift using iRasie implant

Device: iRaise Sinus Lift implant (Maxillent, Herzliya, Israel). Procedure: crestal sinus lift augmentation.

We tested crestal versus lateral approach to the sinus. Crestal approach is made by a novel device (iRaise, implant system). Lateral approach is made conventionally with gold standard procedure (lateral approach).

The iRaise Sinus Lift implant is made of Titanium-6 Aluminum-4 Vanadium alloy, have a surface treated with grit blasting using an apatitic calcium phosphate media, followed by acid etching, and have an internal hexagon connection. Implants have an internal l-shape channel to allow saline and graft passage.

This implants system is made to perform crestal sinus lift procedure at the same time of the implant placement using the same device. After implant site preparation and initial implant placement, the hydraulic system is connected to the implant to allow the injection of saline and then graft the material. Then, the implant, is inserted for its full length.

Group Type: EXPERIMENTAL

Maxillary sinus augmentation

Intervention Type: PROCEDURE

Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.

Lateral sinus lift

Conventional procedure.

Lateral approach to the sinus was made following the conventional procedure.

A window on the lateral wall of the sinus is performed according to a conventional surgical lateral approach to the sinus cavity. Graft materials is filled inside the sinus cavity. Finally, iSure implants [Maxillent] are placed, and flap is sutured.

Group Type: ACTIVE_COMPARATOR

Maxillary sinus augmentation

Intervention Type: PROCEDURE

Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.

Interventions

Maxillary sinus augmentation

Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.

Intervention Type: PROCEDURE

Other Intervention Names

Sinus lift

Eligibility Criteria

Inclusion Criteria

• Partially edentulous patient
• Bilateral edentulism in posterior maxillae (premolars and molars)
• 18 years or older
• Able to understand and sign an informed consent.
• At least 3 months after tooth extraction
• Vertical bone height at the implant sites between 2 to 6 mm
• Bone thickness at least 6 mm as measured on CBCT scan

Exclusion Criteria

• general contraindications to implant surgery
• subjected to irradiation in the head and neck area
• immunosuppressed or immunocompromised
• treated or under treatment with intravenous amino-bisphosphonates
• poor oral hygiene and motivation
• untreated periodontal disease
• uncontrolled diabetes
• pregnant or lactating
• substance abusers
• psychiatric problems
• unrealistic expectations
• lack of opposite occluding dentition/prosthesis
• acute or chronic infection/inflammation
• augmentation/implant placement
• referred only for implant placement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital San Pietro Fatebenefratelli

OTHER

Sponsor Role: lead

Responsible Party

Marco Tallarico

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aldent University

Tirana, , Albania

Countries

Albania

Other Identifiers

iRaise_RCT

Identifier Type: -

Identifier Source: org_study_id