Contact information
Type
Scientific
Primary contact
Dr Ana Roseli de Queiroz Gonçalves
ORCID ID
Contact details
Street benjamin constant 61 s 803
Rio de janeiro
20241150
Brazil
+55 021 81721981
arquegons@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1042
Study information
Scientific title
Acronym
Study hypothesis
This study aimed at analysing the success of maxillary sinus graft using biomaterial (demineralised bovine bone graft) and platelets-rich plasma. Bone neoformation and implant success rate were recorded.
Ethics approval
No ethics approval was sought as this trial used only routine procedures, and informed consent was obtained from all participants.
Study design
Interventional single-arm trial
Primary study design
Interventional
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Grafts for severely reabsorbed edges of the maxillary sinus after tooth extraction
Intervention
All participants received maxillary sinus graft using biomaterial (demineralised bovine bone graft) and platelets-rich plasma. The implant was evaluated at 6 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The following were assessed at 6 months:
1. Implant failure rate
2. Success rate of implants
3. Graft bone formation rate
Secondary outcome measures
The following were assessed at 6 months:
1. Bone density (subjective), defined during the surgery - D3
2. Sub-antral rating as measured by three-dimensional imaging or radiography - SA1
Overall trial start date
01/09/2006
Overall trial end date
29/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, no age limits
2. Patients who were admitted to the Centre for Post-Graduate Studies, Dental Center CLIVO, Rio de Janeiro (AORJ, FAISA/ CIODONTO), who needed graft in the maxillary sinus for the insertion of implants and subsequent construction of the prosthesis
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
30
Participant exclusion criteria
Cases in which, at the time of surgery, membrane was pierced greater than 2 mm, resulting in the abortion procedure.
Recruitment start date
01/09/2006
Recruitment end date
29/02/2008
Locations
Countries of recruitment
Brazil
Trial participating centre
Street benjamin constant 61 s 803
Rio de janeiro
20241150
Brazil
Sponsor information
Organisation
Dental Center CLIVO (Centro Livre de Odontologia) (Brazil)
Sponsor details
Rio de Janeiro College of Dentistry (AORJ)
RUA Barão do Flamengo
22 S 801
Rio de Janeiro
22220-080
Brazil
+55 021 2225 4113
cursos@clivo.com.br
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Dental Center CLIVO (Centro Livre de Odontologia), Rio de Janeiro College of Dentistry (AORJ, FAISA/CIODONTO) (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary