Clinical Trials Directory

Trials / Completed

CompletedNCT04111250

Crestal vs Lateral Sinus Lift Augmentation

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Hospital San Pietro Fatebenefratelli · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREMaxillary sinus augmentationRaise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.

Timeline

Start date
2015-11-01
Primary completion
2018-03-30
Completion
2019-04-02
First posted
2019-10-01
Last updated
2019-10-01

Locations

1 site across 1 country: Albania

Source: ClinicalTrials.gov record NCT04111250. Inclusion in this directory is not an endorsement.