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Use of the combination of Injectable platelet-rich fibrin with Plenum-oss® in maxillary sinus membrane elevation surgery

Controlled, randomized, double-blind clinical study of the predictability of the association of i-PRF with Plenum-oss® in maxillary sinus membrane elevation surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-63frmt7
Enrollment
Unknown
Registered
2025-07-25
Start date
2024-06-27
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Maxilla

Interventions

This is a randomized controlled clinical study, double-blind. Both the researchers who will evaluate the outcomes and the participants will not know which group each participant belongs to. The proced
Group 2 (experimental) - 10 maxillary sinuses grafted with hydroxyapatite (70%) + ß-tricalcium phosphate (30%)
Group 3 (experimental) - 10 maxillary sinuses grafted with hydroxyapatite (70%) + ß-tricalcium phosphate (30%) associated with i-PRF (1:1)
Group 4 (experimental) - 10 maxillary sinuses grafted with hydroxyapatite (70%) + ß-tricalcium phosphate (30%) associated with autogenous bone (1:1). The procedure for maxillary sinus lift will be per

Sponsors

Universidade estadual Paulista Júlio de Mesquita Filho - Campus Araraquara
Lead Sponsor
Faculdade de Odontologia da Universidade Estadual Paulista UNESP - Araraquara
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients aged at least 18 years; both sexes; healthy; with maxillary ridge atrophy with bone height less than 5 mm

Exclusion criteria

Exclusion criteria: Smoker; uncontrolled systemic diseases; blood dyscrasias; sinus pathologies; current or previous use of medications that interfere with bone turnover; irradiated in the head and neck region; pregnant women; untreated periodontal diseases

Design outcomes

Primary

MeasureTime frame
Bone volume gain and maintenance in the maxillary sinus after grafting, assessed by comparing cone beam computed tomography scans performed preoperatively, immediately postoperatively 15 days after tooth extraction, and late postoperatively after six months. Bone volume was calculated using three-dimensional segmentation software to determine whether the use of hydroxyapatite (70%) + ß-tricalcium phosphate (30%) associated with i-PRF promotes greater maintenance of graft volume when compared to the control group and the groups treated with hydroxyapatite (70%) + ß-tricalcium phosphate (30%) associated with autogenous bone and hydroxyapatite (70%) + ß-tricalcium phosphate (30%) alone. The difference in bone volume between the periods will be used to determine the effectiveness of each intervention in gaining and maintaining bone volume prior to the installation of dental implants.

Secondary

MeasureTime frame
Evaluation of new bone formation and the remaining synthetic graft through histomorphometric and immunohistochemical analysis performed from biopsies collected at the time of dental implant installation, as well as the evaluation of the safety of the PlenumOss synthetic graft (hydroxyapatite (70%) + ß-tricalcium phosphate (30%)) and the different treatments investigated, through the recording of adverse events such as persistent pain, exacerbated edema, infection and dehiscence of the surgical wound throughout the patient follow-up period

Countries

Brazil

Contacts

Public ContactMiguel Santos

Universidade estadual Paulista Júlio de Mesquita Filho - Campus Araraquara

miguel.mata@unesp.br+55(16)3301-6300

Outcome results

None listed

Source: REBEC (via WHO ICTRP)