The assessment of the success of implants in the maxillary sinus graft
ISRCTN | ISRCTN24003246 |
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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
Scientific
Street benjamin constant 61 s 803
Rio de janeiro
20241150
Brazil
Phone | +55 021 81721981 |
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arquegons@hotmail.com |
Study information
Study design | Interventional single-arm trial |
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Primary study design | Interventional |
Secondary study design | Other |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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(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) studied | 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 |
Primary outcome measure | 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 study start date | 01/09/2006 |
Completion date | 29/02/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Other |
Sex | Both |
Target number of participants | 30 |
Key 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 |
Key exclusion criteria | Cases in which, at the time of surgery, membrane was pierced greater than 2 mm, resulting in the abortion procedure. |
Date of first enrolment | 01/09/2006 |
Date of final enrolment | 29/02/2008 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Street benjamin constant 61 s 803
Rio de janeiro
20241150
Brazil
20241150
Brazil
Sponsor information
Dental Center CLIVO (Centro Livre de Odontologia) (Brazil)
Hospital/treatment centre
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 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |