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Use of animal derived bone substitutes in oral reahabilitation

Xenogenous bone grafts

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5fx9cvc
Enrollment
Unknown
Registered
2020-11-30
Start date
2017-07-02
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

Alveolar ridge atrophy

Interventions

Horizontal ridge augentation with deproteinized bovine bone blocks, comapred to autologous block from mandibular ramus, in aplit-mouth study design. 12 health patients, aging from 18-75 years-old rece
A01.941.875

Sponsors

Universidade Estadual Paulista, Faculdade de Odontologia de Araraquara
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: adult (over 18 years old); any sex; with totally edentulous maxillary ridge; remaining alveolar bone width between 2 and 10mm; remaining alveolar height of at least 10mm.

Exclusion criteria

Exclusion criteria: Smokers; chronic unstable systemic illnesses; pregnant or nursing women; under chemotherapy or radiotherapy; with active sites of infection; who take medications which affects the bone metabolism; with recent extraction socket in the area of interest; patients with bad oral habits that could affect the bone repair.

Design outcomes

Primary

MeasureTime frame
The main outcome was the incorporation of the graft to the donor site. These outcome was assessed by computed tomography, in three different periods: pre-operative, immediately after graft placement, and 9 motnhs after healing. Clinical measurements of thickness and volume were also performed, as well as bone biopsies of grafted areas, to evaluate the microarchitectural pattern and histolgoical incorporation of graft. The bone volume was expressed in mm³; the micro architechture was assessed by bone volume ratio, trabecular number, thickness and separation, also connectivity and trabecular pattern. The histological incorporation was assessed by percentage of mineralized tissue and percentage of remnant biomaterial. ;Another primary outcome was the clinical complications after graft placement, this complications were assessed by qualitative classfication, in each post operative appointments. The researches evalauted: wound dehiscence, paresthesia, wound infection, swelling, haemathoma, and seroma formation thoughout visual evaluation and inquiring.

Secondary

MeasureTime frame
Secondary outcome was the realibility of implant placement in grafted areas. This reliability was assessed thorghout implant instalation torque. The implant torque was measured by a digital torquimeter attached to the counter angle head, and measuren in Newtons, .;Another secondary outcome was the implant stability quocient, the stability was assessed by frequncimenter Ostell, measured in a standard scale betwenn 0 and 100, being 100 the most stable condition.

Countries

Brazil

Contacts

Public ContactPedro Henrique;Valfrido Carvalho;Pereira-Filho

Universidade Estadual Paulista, Faculdade de Odontologia de Araraquara;Universidade Estadual Paulista, Faculdade de Odontologia de Araraquara

pedro.azambuja@unesp.br;dinho@foar.unesp.br+55-53-984247626;+55-16-33016386

Outcome results

None listed

Source: REBEC (via WHO ICTRP)