This trial is active, not recruiting.

Conditions disorder of maxillary sinus, accessory; bone, bone atrophy
Treatments freeze bone allograft, lyophilized bone allograft
Sponsor University of Sao Paulo
Start date June 2014
End date December 2016
Trial size 15 participants
Trial identifier NCT02583737, CAEE 30738714.0.0000.0075.


Bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and many biomaterials have been used to solve filling issues to maintain the sinus floor lifted in a position that can allow dental implants installation. Bone grafts have shown to be the best choice of filling grafts. Despite autologous bone are the gold standard filling biomaterial it is associates with great mortality and morbidity. So, bone allografts from tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue bone are the most common allografts but literature is poor in randomized controlled parallel clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and freeze bone allografts from human bone tissue bank. The investigators want to verify which one can develop greater osteogenesis, if is there any difference between them regarding the architectural trabeculae formation, if there are different patterns of reabsorption and finally if is there any differences between them regarding primary and lately dental implants stability. To answer those questions the investigators propose firstly, to carry out microtomographic and histological analysis from trephine bone samples after six months of sinus lifting and grafting in healthy participants undergoing osseointegrated dental implants. Secondly, the primary and lately implant stability is going to be achieved employing Resonance Frequency Analysis (RFA).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
(Active Comparator)
sinus lifting with tissue bank lyophilized bone filling
lyophilized bone allograft
sinus lifting filling procedure employing lyophilized bone allograft from tissue bone bank.
(Active Comparator)
sinus lifting with freeze bone bank filling
freeze bone allograft
sinus lifting filling procedure employing freeze bone allograft from tissue bone bank.

Primary Outcomes

volume of bone neoformation in mm3
time frame: six months after grafting
area of bone neoformation in μm2
time frame: six months after grafting

Secondary Outcomes

dental implants stability value
time frame: six months after grafting
dental implants stability value
time frame: six months after dental implant

Eligibility Criteria

Male or female participants from 30 years up to 60 years old.

Inclusion Criteria: - healthy - totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region. Exclusion Criteria: - recent sinusitis history - hypersensibility for sinus allergens, tabagism, ethylism - severe periodontal disease, diabetes, hypertension. - Cases that occur schneiderian membrane perforation will be excluded from the final sample.

Additional Information

Official title Histological and Microtomographic Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting: A Randomized Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.