Clinical trial NCT04111250: 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
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Alveolar Ridge
Bone Atrophy, Alveolar
Keywords: Dental implants
Maxillary sinus augmentation
Crestal approach
Lead sponsor: Hospital San Pietro Fatebenefratelli
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prosthesis failure
timeFrame: Up to 5 years
measure: Implant failure
timeFrame: Up to 5 years
measure: Complications
timeFrame: Up to 5 years
measure: Patient's preference (questionnaire)
timeFrame: Assessed 1 week and 1 month after surgery
Secondary outcomes:
measure: Time (minutes)
timeFrame: The time in minutes of the surgical procedure, from the incision of the gingiva to the placement of the last stitch
measure: Marginal bone loss
timeFrame: 1 year after loading
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: Aldent University
Study officials:
References: