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Crestal vs Lateral Sinus Lift Augmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111250
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Marco Tallarico, Hospital San Pietro Fatebenefratelli

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.

Condition or disease Intervention/treatment Phase
Edentulous Alveolar Ridge Bone Atrophy, Alveolar Procedure: Maxillary sinus augmentation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split mouth design
Masking: Single (Outcomes Assessor)
Masking Description: Where possible, outcomes assessor was blinded.
Primary Purpose: Treatment
Official Title: Crestal Versus Lateral Sinus Lift: One-year Results From a Within-patient Randomised Controlled Trial
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : April 2, 2019

Arm Intervention/treatment
Experimental: 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.

Procedure: Maxillary sinus augmentation
Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.
Other Name: Sinus lift

Active Comparator: 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.

Procedure: Maxillary sinus augmentation
Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.
Other Name: Sinus lift




Primary Outcome Measures :
  1. Prosthesis failure [ Time Frame: Up to 5 years ]
    Planned prosthesis which could not be placed due to implant failure(s), loss of the prosthesis secondary to implant failure(s) or a prosthesis that had to be remade for any reasons.

  2. Implant failure [ Time Frame: Up to 5 years ]
    Implant mobility, removal of stable implants dictated by progressive marginal bone loss or infection, and implants fracture or any other mechanical complications rendering the implant unusable. The stability of each individual implant was measured with the removed prosthesis at abutment connection, at delivery definitive prostheses and at 1 year after loading, by tightening the implant abutment screws with a torque of 20 Ncm or by assessing the stability of individual crowns using the handles of two metallic instruments.

  3. Complications [ Time Frame: Up to 5 years ]
    Any technical and biological complications

  4. Patient's preference (questionnaire) [ Time Frame: Assessed 1 week and 1 month after surgery ]
    Answers: 1) the side treated with the crestal technique, 2) the side treated with the lateral technique, 3) none, both treatments were equally good, 4) none, both treatments were equally bad.


Secondary Outcome Measures :
  1. Time (minutes) [ Time Frame: The time in minutes of the surgical procedure, from the incision of the gingiva to the placement of the last stitch ]
    Time needs to perform the procedure, starting from the surgical incision to the delivery of the last suture, including the additional implants.

  2. Marginal bone loss [ Time Frame: 1 year after loading ]
    Assessed on digital periapical radiographs taken with the paralleling technique at implant placement, prosthesis delivery and 1 year after loading using a digital apparatus (CS 2100, Carestream Dental, Rochester, NY, US). In the case of a not properly readable radiograph, the radiograph was to be taken again. Radiographs were stored in a TIFF format with a 600 dpi resolution, in a personal computer. Peri-implant marginal bone levels were measured using the DFW 2.8 software for windows (Soredex, Tuusula, Finland). The software was calibrated for every single image using the known implant diameter. The distance between marginal bone level and implant/abutment junction, was measured at both mesial and distal sides to the nearest 0.01 mm and averaged. Bone level changes at single implants was averaged at sinus level and then at group level. Reference points for the linear measurements were: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111250


Locations
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Albania
Aldent University
Tirana, Albania
Sponsors and Collaborators
Hospital San Pietro Fatebenefratelli
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Responsible Party: Marco Tallarico, Lecturer, Hospital San Pietro Fatebenefratelli
ClinicalTrials.gov Identifier: NCT04111250    
Other Study ID Numbers: iRaise_RCT
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Tallarico, Hospital San Pietro Fatebenefratelli:
Dental implants
Maxillary sinus augmentation
Crestal approach
Additional relevant MeSH terms:
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Alveolar Bone Loss
Atrophy
Pathological Conditions, Anatomical
Mouth Diseases
Stomatognathic Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases