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Crestal vs Lateral Sinus Lift Augmentation

Primary Purpose

Edentulous Alveolar Ridge, Bone Atrophy, Alveolar

Status
Completed
Phase
Not Applicable
Locations
Albania
Study Type
Interventional
Intervention
Maxillary sinus augmentation
Sponsored by
Hospital San Pietro Fatebenefratelli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring Dental implants, Maxillary sinus augmentation, Crestal approach

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aldent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crestal sinus lift using iRasie implant

Lateral sinus lift

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Prosthesis failure
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.
Implant failure
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.
Complications
Any technical and biological complications
Patient's preference (questionnaire)
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

Time (minutes)
Time needs to perform the procedure, starting from the surgical incision to the delivery of the last suture, including the additional implants.
Marginal bone loss
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.

Full Information

First Posted
June 16, 2019
Last Updated
September 29, 2019
Sponsor
Hospital San Pietro Fatebenefratelli
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1. Study Identification

Unique Protocol Identification Number
NCT04111250
Brief Title
Crestal vs Lateral Sinus Lift Augmentation
Official Title
Crestal Versus Lateral Sinus Lift: One-year Results From a Within-patient Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Pietro Fatebenefratelli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge, Bone Atrophy, Alveolar
Keywords
Dental implants, Maxillary sinus augmentation, Crestal approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth design
Masking
Outcomes Assessor
Masking Description
Where possible, outcomes assessor was blinded.
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crestal sinus lift using iRasie implant
Arm Type
Experimental
Arm Description
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.
Arm Title
Lateral sinus lift
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Maxillary sinus augmentation
Other Intervention Name(s)
Sinus lift
Intervention Description
Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.
Primary Outcome Measure Information:
Title
Prosthesis failure
Description
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.
Time Frame
Up to 5 years
Title
Implant failure
Description
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.
Time Frame
Up to 5 years
Title
Complications
Description
Any technical and biological complications
Time Frame
Up to 5 years
Title
Patient's preference (questionnaire)
Description
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.
Time Frame
Assessed 1 week and 1 month after surgery
Secondary Outcome Measure Information:
Title
Time (minutes)
Description
Time needs to perform the procedure, starting from the surgical incision to the delivery of the last suture, including the additional implants.
Time Frame
The time in minutes of the surgical procedure, from the incision of the gingiva to the placement of the last stitch
Title
Marginal bone loss
Description
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.
Time Frame
1 year after loading

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Aldent University
City
Tirana
Country
Albania

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Crestal vs Lateral Sinus Lift Augmentation

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