Public trial
RBR-4dct89b Clinical Study of Bone Grafting in Dentistry
Date of registration: 04/18/2022 (mm/dd/yyyy)Last approval date : 05/26/2025 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Randomized Prospective Longitudinal Study of Calcium Phosphate Biphasic Graft
pt-br
Estudo Longitudinal Prospectivo Randomizado de Enxerto Bifásico de Fosfato de Cálcio
es
Randomized Prospective Longitudinal Study of Calcium Phosphate Biphasic Graft
Trial identification
- UTN code: U1111-1276-5336
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Public title:
en
Clinical Study of Bone Grafting in Dentistry
pt-br
Estudo Clínico de Enxerto Ósseo em Odontologia
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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47899821.0.0000.0121
Issuing authority: Plataforma Brasil
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5.245.340
Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de Santa Catarina
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47899821.0.0000.0121
Sponsors
- Primary sponsor: Universidade Federal de Santa Catarina
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Secondary sponsor:
- Institution: Dentscare - LTDA
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Supporting source:
- Institution: Dentscare - LTDA
- Institution: Universidade Federal de Santa Catarina
Health conditions
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Health conditions:
en
Loss of teeth due to accident, extraction or localized periodontal disease; Atrophy of the toothless alveolar ridge; Jaw Edentulous; Jaw Edentulous Partially
pt-br
Perda de dentes devida a acidente, extração ou a doenças periodontais localizadas; Atrofia do rebordo alveolar sem dentes; Arcada Edêntula; Arcada parcialmente edêntula
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General descriptors for health conditions:
en
C07.465.714.804 tooth loss
pt-br
C07.465.714.804 Perda de dente
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Specific descriptors:
en
K08.1 Loss of teeth due to accident, extraction or localized periodontal disease
pt-br
K08.1 Perda de dentes devida a acidente, extração ou a doenças periodontais localizadas
en
K08.2 Atrophy of the toothless alveolar ridge
pt-br
K08.2 Atrofia do rebordo alveolar sem dentes
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C05.500.480 Jaw, Edentulous
pt-br
C05.500.480 Arcada Edêntula
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C05.500.480.450 Jaw, Edentulous, Partially
pt-br
C05.500.480.450 Arcada parcialmente edêntula
Interventions
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Interventions:
en
This is a longitudinal and prospective randomized clinical study. Experimental groups: G1A: 50 areas (patients) for maxillary sinus lift with 200-500 µm granulation; G1B: 50 areas (patients) for maxillary sinus lifting with granulation 500-1000 µm; G1C: 50 areas (patients) for sinus maxillary lifting with granulation 1000-2000 µm; G2A: 50 areas (patients) to fill fresh sockets after tooth extraction with granulation 200-500 µm; G2B: 50 areas (patients) to fill fresh sockets after tooth extraction with granulation 500-1000 µm; G2C: 50 areas (patients) to fill fresh sockets after tooth extraction with granulation 1000-2000 µm; G3A: 50 areas (patients) to fill the gap between implant and alveolar bone plate after extraction and installation of immediate dental implant with granulation 200-500 µm; G3B: 50 areas (patients) to fill the gap between implant and alveolar bone plate after extraction and installation of immediate dental implant with granulation 500-1000 µm. Control groups: G1D: 50 areas (patients) for maxillary sinus lifting with similar material (BoneceramicR) with granulation 500-1000 µm; G2D: 50 areas (patients) for filling fresh sockets after tooth extraction with similar material (BoneceramicR) with granulation 500-1000 µm; G3C: 50 areas (patients) to fill the gap between implant and alveolar bone plate after extraction and immediate dental implant placement with similar material (BoneceramicR) with granulation 500-1000 µm.
pt-br
Trata-se de um estudo clínico randomizado longitudinal e prospectivo. Grupos experimentais: G1A: 50 áreas (pacientes) para levantamento de seio maxilar com granulação 200-500 µm; G1B: 50 áreas (pacientes) para levantamento de seio maxilar com granulação 500-1000 µm; G1C: 50 áreas (pacientes) para levantamento de seio maxila com granulação 1000-2000 µm; G2A: 50 áreas (pacientes) para preenchimento de alvéolos frescos após exodontia com granulação 200-500 µm; G2B: 50 áreas (pacientes) para preenchimento de alvéolos frescos após exodontia com granulação 500-1000 µm; G2C: 50 áreas (pacientes) para preenchimento de alvéolos frescos após exodontia com granulação 1000-2000 µm; G3A: 50 áreas (pacientes) para preenchimento do gap entre implante e tábua óssea alveolar após exodontia e instalação de implante dentário imediato com granulação 200-500 µm; G3B: 50 áreas (pacientes) para preenchimento do gap entre implante e tábua óssea alveolar após exodontia e instalação de implante dentário imediato com granulação 500-1000 µm. Grupos controle: G1D: 50 áreas (pacientes) para levantamento de seio maxilar com material similar (BoneceramicR) com granulação 500-1000 µm; G2D: 50 áreas (pacientes) para preenchimento de alvéolos frescos após exodontia com material similar (BoneceramicR) com granulação 500-1000 µm; G3C: 50 áreas (pacientes) para preenchimento do gap entre implante e tábua óssea alveolar após exodontia e instalação de implante dentário imediato com material similar (BoneceramicR) com granulação 500-1000 µm.
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Descriptors:
en
E06.892 Oral Surgery
pt-br
E06.892 Cirurgia Bucal
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E04.545.550.280 dental implantation
pt-br
E04.545.550.280 implantação dentária
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D25.130 biocompatible materials
pt-br
D25.130 materiais biocompatíveis
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 03/01/2022 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 550 - 12 Y 0 -
Inclusion criteria:
en
Patients who have indications for bone grafting in maxillary sinus lift, socket filling after tooth extraction and filling the gap after implantation immediately after tooth extraction, compatible with indications for the use of bone graft biomaterials; patients over 12 years old; both genders
pt-br
Pacientes que apresentem indicações para enxertia óssea em levantamento de seio maxilar, preenchimento de alvéolo após exodontia e preenchimento do gap após implantação imediatamente após exodontia, compatíveis com indicações de uso dos biomateriais de enxertia óssea; pacientes maiores de 12 anos; ambos os sexos
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Exclusion criteria:
en
Patients under 12 years old; patients with infected areas and acute inflammatory processes; Pregnant or breastfeeding patients; patients with endocrine diseases or uncompensated chronic diseases such as diabetes, autoimmune dysfunction, therapy; or using drugs that compromise the healing response of bone tissue como prolonged therapy with corticosteroids, chemotherapy, bisphosphonates
pt-br
Pacientes menores de 12 anos; pacientes com áreas infectadas e processos inflamatórios agudos; pacientes gestantes ou lactentes; pacientes com doenças endócrinas ou doenças crônicas não compensadas como diabetes, disfunção autoimune, terapia; ou em uso de medicamentos que comprometam a resposta cicatricial do tecido ósseo como terapia prolongada com corticosteroides, quimioterapia, bifosfonatos
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Parallel 4 Double-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
The effectiveness of the biphasic ceramic will allow a tissue and clinical behavior equivalent to the control groups, when the characteristics of volume maintenance and reconstruction of the required areas are evaluated.
pt-br
A eficácia da cerâmica bifásica permitirá um comportamento tecidual e clínico equivalente aos grupos controle, quando avaliadas as características de manutenção de volume e reconstruções das áreas requeridas.
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Secondary outcomes:
en
The effectiveness of biphasic ceramic in relation to tissue and clinical behavior will be equivalent in all granulations used (200-500 μm, 500-1000 μm and 1000-2000 μm).
pt-br
A eficácia da cerâmica bifásica em relação ao comportamento tecidual e clínico será equivalente em todas as granulações utilizadas (200-500 μm, 500-1000 μm e 1000-2000 μm).
Summary Results
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Baseline char:
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Participants ranged in age from 18 to 79 and lived in Florianópolis and the metropolitan region. The groups were mostly made up of women, who made up 59% of the participants. The average age for both sexes was around 55 years old
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Participants flow:
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Due to the pandemic (COVID-19) and the occurrence of a public servants' strike in the first half of 2024, the recruitment of research participants will need to be extended. To date, 39 patients have been treated, totaling 78 grafted areas
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Adverse events:
en
No adverse events reported
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Outcome measure:
en
Of the 78 grafted areas, 60 correspond to the test groups and 18 to the control groups. Of the 60 areas related to the test groups, 26 correspond to sinus lift cases, 19 correspond to cases of filling fresh alveoli after exodontia and 15 correspond to filling gaps between implant and alveolar bone plate after exodontia and immediate dental implant installation. 100% of the areas proved to be suitable for dental implants and there were no failures in the grafted areas
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Results summary:
en
The use of autogenous grafts has been considered the “gold standard” for alveolar ridge reconstruction in dental implant rehabilitation. However, this technique has disadvantages such as increased morbidity, limited quantity of material, technical difficulty and graft resorption. Bone substitutes have therefore been advocated as an alternative to autogenous grafts. Against this backdrop, the aim of this study was to evaluate the performance of the Nanosynt® bone substitute in surgical techniques, during and after oral rehabilitation. Patients over the age of 12 with indications for bone grafting in maxillary sinus lift, socket filling after exodontia and gap filling after implantation immediately after exodontia take part in the study. After screening, the patients are randomly allocated into 4 groups (Nanosynt® 200-500µm, Nanosynt® 500-1000µm, Nanosynt® 1000-2000µm or Straumann® BoneceramicTM 500-1000 µm) according to their treatment needs. The quantitative measurement of the bone tissue gained is carried out by a blinded operator through the analysis of standardized cone beam CT scans. For this purpose, CT scans are obtained before and after grafting, at the times assigned to each group. To date, 100% of the grafted areas have proved suitable for dental implants, with no failures or adverse events reported
Data Sharing Plan
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Data Sharing Plan:
en
No
Contacts
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Public contact
- Full name: Roberta Uyara Ferreira
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- Address: Av. Edgar Nelsom Meister, 474 - Zona Industrial Norte
- City: Joinville / Brazil
- Zip code: 89219-501
- Phone: +55 47 99160-4500
- Email: roberta.uyara@fgmdentalgroup.com
- Affiliation: Dentscare - LTDA
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Scientific contact
- Full name: Rafael Cury Cecato
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- Address: R. Eng. Agronômico Andrei Cristian Ferreira, s/n - Trindade - Universidade Federal de Santa Catarina/Campus Florianópolis - Centro de Ciências da Saúde / Departamento de Odontologia - Centro de Ensino e Pesquisa em Implantes Dentários
- City: Florianópolis / Brazil
- Zip code: 88040-900
- Phone: +55 48 3721-9077
- Email: rafaelcurycecato@hotmail.com
- Affiliation: Universidade Federal de Santa Catarina
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Site contact
- Full name: Cesar Augusto Magalhães Benfatti
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- Address: R. Eng. Agronômico Andrei Cristian Ferreira, s/n - Trindade - Universidade Federal de Santa Catarina/Campus Florianópolis - Centro de Ciências da Saúde / Departamento de Odontologia - Centro de Ensino e Pesquisa em Implantes Dentários
- City: Florianópolis / Brazil
- Zip code: 88040-900
- Phone: +55 (48) 3721 3407
- Email: cesarbenfatti@yahoo.com
- Affiliation: Universidade Federal de Santa Catarina
Additional links:
Total de Ensaios Clínicos 18841.
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