Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT04111250
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2019-06-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Crestal vs Lateral Sinus Lift Augmentation
Sponsor:
Hospital San Pietro Fatebenefratelli
Organization:
Study Overview
Official Title:
Crestal Versus Lateral Sinus Lift: One-year Results From a Within-patient Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: