The assessment of the success of implants in the maxillary sinus graft

ISRCTN ISRCTN24003246
DOI https://doi.org/10.1186/ISRCTN24003246
Secondary identifying numbers 1042
Submission date
20/10/2008
Registration date
27/10/2008
Last edited
27/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ana Roseli de Queiroz Gonçalves
Scientific

Street benjamin constant 61 s 803
Rio de janeiro
20241150
Brazil

Phone +55 021 81721981
Email arquegons@hotmail.com

Study information

Study designInterventional single-arm trial
Primary study designInterventional
Secondary study designOther
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThis 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(s)No ethics approval was sought as this trial used only routine procedures, and informed consent was obtained from all participants.
Health condition(s) or problem(s) studiedGrafts for severely reabsorbed edges of the maxillary sinus after tooth extraction
InterventionAll participants received maxillary sinus graft using biomaterial (demineralised bovine bone graft) and platelets-rich plasma. The implant was evaluated at 6 months.
Intervention typeOther
Primary outcome measureThe following were assessed at 6 months:
1. Implant failure rate
2. Success rate of implants
3. Graft bone formation rate
Secondary outcome measuresThe 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 study start date01/09/2006
Completion date29/02/2008

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants30
Key inclusion criteria1. 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
Key exclusion criteriaCases in which, at the time of surgery, membrane was pierced greater than 2 mm, resulting in the abortion procedure.
Date of first enrolment01/09/2006
Date of final enrolment29/02/2008

Locations

Countries of recruitment

  • Brazil

Study participating centre

Street benjamin constant 61 s 803
Rio de janeiro
20241150
Brazil

Sponsor information

Dental Center CLIVO (Centro Livre de Odontologia) (Brazil)
Hospital/treatment centre

Rio de Janeiro College of Dentistry (AORJ)
RUA Barão do Flamengo
22 S 801
Rio de Janeiro
22220-080
Brazil

Phone +55 021 2225 4113
Email cursos@clivo.com.br
Website http://www.clivo.com.br

Funders

Funder type

University/education

Dental Center CLIVO (Centro Livre de Odontologia), Rio de Janeiro College of Dentistry (AORJ, FAISA/CIODONTO) (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan