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

ISRCTN	ISRCTN24003246
DOI	https://doi.org/10.1186/ISRCTN24003246
Protocol serial number	1042
Sponsor	Dental Center CLIVO (Centro Livre de Odontologia) (Brazil)
Funder	Dental Center CLIVO (Centro Livre de Odontologia), Rio de Janeiro College of Dentistry (AORJ, FAISA/CIODONTO) (Brazil)

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

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

Primary study design	Interventional
Study design	Interventional single-arm trial
Secondary study design	Other
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(s)	The following were assessed at 6 months: 1. Implant failure rate 2. Success rate of implants 3. Graft bone formation rate
Key secondary outcome measure(s)	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
Completion date	29/02/2008

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

Street benjamin constant 61 s 803

Rio de janeiro
20241150
Brazil

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan