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Completed

NCT Number: NCT04111250

Crestal vs Lateral Sinus Lift Augmentation

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.

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Key information

Conditions

Edentulous Alveolar Ridge Alveolar Bone Loss Bone Atrophy, Alveolar Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aldent University

Tirana, Albania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maxillary sinus augmentation

Procedure

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

Other names: Sinus lift

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital San Pietro Fatebenefratelli

Other

Registry information

Official study title

Crestal Versus Lateral Sinus Lift: One-year Results From a Within-patient Randomised Controlled Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 1, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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