Condition category
Oral Health
Date applied
20/10/2008
Date assigned
27/10/2008
Last edited
27/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.clivo.com.br

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

Publication citations

Additional files

Editorial Notes