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Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management. 22
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07492576 é um estudo intervencionista para Colocação de implante imediato. Seu status atual é: em recrutamento. O estudo começou em 19 de março de 2026 e pretende incluir 22 participantes. Coordenado por British University In Egypt e deve ser concluído em 29 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de março de 2026.
Resumo
Will (GBR) by application of magnesium membrane with immediate implant will have more volume gain , higher pink esthetic score, and lower visual analogue scale than dual zone grafting technique? Several methods have been suggested for the preservation of post-extraction resorption and promoting an increase in the bone density with immediate implant placement. one of these techniques is the dual zone concept (DZ), atr...Mostrar mais
Título oficial
Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management: a Randomized Controlled Clinical Trial
Condições médicas
Colocação de implante imediatoPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:- 4. E. Gurbuz, E. Ceylan: Comparison of a non-grafted socket shield technique with guided bone regeneration in immediate implant placement: a randomized clinical trial. Int. J. Oral Maxillofac. Surg. 2025; 54: 356-364. © 2024.
- 3. Araújo MG, Wennström JL, Lindhe J. Modeling of the buccal and lingual bone walls of fresh extraction sites followin...
Outros IDs do estudo
- 25-050
Número NCT
Data de início (real)
2026-03-19
Última atualização postada
2026-03-25
Data de conclusão (estimada)
2026-12-29
Inscrição (estimada)
22
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
Magnesium shield ,
Immidate implant
dual zone concept with immediate implant.
Immidate implant
dual zone concept with immediate implant.
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Experimentalmagnesium shield (GBR) Atraumatic flapless tooth extraction using periotomes and forceps will be performed to preserve the available labial bone wall the alveolus will be curetted with a curette, and the remaining inflammatory tissue will be removed. Then, the implant site will be prepared, and the implant will be inserted \[8\]. A novel magnesium membrane will be placed between thin labial bone wall and soft tissue. the membrane will be c...Mostrar mais | GBR surgery using magnesium Shield Atraumatic flapless tooth extraction using periotomes and forceps will be performed to preserve the available labial bone wall the alveolus will be curetted with a curette, and the remaining inflammatory tissue will be removed. Then, the implant site will be prepared, and the implant will be inserted \[8\]. A novel magnesium membrane will be placed between thin labial bone wall and soft tissue. the membrane will be c...Mostrar mais |
Comparador ativoDual Zone concept (DZ) technique ( control group ) Atraumatic flapless tooth extraction using peristomes and luxators, then Osteotomy site preparation will be done according to the manufacturers.
instructions followed by immediate implant placement. The implant will be 3-4m.m apical to the free gingival margin (FGM) , engaging intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which will be set to b...Mostrar mais | Dual Zone concept (DZ) technique Atraumatic flapless tooth extraction using peristomes and luxators, then Osteotomy site preparation will be done according to the manufacturers.
instructions followed by immediate implant placement. The implant will be 3-4m.m apical to the free gingival margin (FGM) , engaging intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which will be set to be at least 35 Ncm ...Mostrar mais |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
bucco-palatal dimensional ridge changes | The Bucco-palatal dimensional ridge alterations were assessed via digital scans to assess the difference and changes in the overall ridge dimensions (mm). Reference points were assigned in the baseline measurements of the scans using the Standard Triangle Language (STL) files of the models obtained via digital scanning to allow standardized comparisons after 3,6, and 9 months. The 3D software allowed the alignment of the reference points identified on the models. | Pre-operative , day 1 , then 3,6 , 9 months later |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Pink esthetic score (PES) | Pink esthetic score will be recorded for five variables: "mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site". A score of 2, 1, or 0 will be assigned to all five PES parameters.
The two papillary scores (mesial and distal) will be assessed for the complete presence (score 2), incomplete presence (score 1) or absence (score0) of papillary tissue. The curvature of the facial soft tissue line, also defined as the line of emergence of the implant restoration from the soft tissues, will be evaluated as being identical (score 2 ), slightly different (score 1), or markedly different (score 0) compared to the natural control tooth and thus, provided a natural symmetrical or disharmonious appearance and in comparison to the contralateral tooth in terms of an identical vertical level (score 2), a slight (\<1 mm) discrepancy (score 1), or a major (\>1 mm) discrepancy | Baseline, 3 , 6,and 9 months |
• Volumetric changes ( digital scanner ) | To assess the volumetric differences between the baseline, 3, 6 and 9 months postoperatively, digital replica using scanner. Digital replicas were produced resembling various time intervals during treatment. Superimposing the different replicas of each case utilizing the best fit algorithm by using reference points from the tooth surfaces. The implant site region was delineated by the mucogingival line, the mesial and distal papillary midline, and the alveolar crest. Thus, alterations in volume between the digitized superimposed replicas could be recorded. (Akcali et al., 2015). | Pre-operative ,day 1 , 3,6 ,and 9 months |
• Mid facial mucosal recession (MFR) | changes were assessed by three measurements, taken at the tip of the mesial papillae, tip of the distal papillae, and mid-facial gingival margin, preoperative, once at baseline and were compared to measurements after ,3, 6, and 9 months. | Pre-operative baseline and 3,6,9 months |
• Labial bone thickness | Assessed on the sagittal section of the CBCT at three points: the implant platform (crestal thickness), half of the implant length (middle thickness) and implant apex (apical thickness). | The labial bone thickness will be measured at day 1and 9 months later |
• Soft tissue thickness (STT) | using an anesthetic needle with rubber stopper to pierce the gingiva horizontally and perpendicular to the long axis of the tooth till bone contact 2mm coronal to the MGJ and in the mid distance mesiodistally. The part of the instrument penetrating into soft tissue will be measured in mm. (Cairo et al 2017) | measured at baseline and 9 months |
Visual analogue scale measures postoperative pain (VAS) | Pain score is reported by the patient directly through The Visual Analogue Scale score (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain) | 3 days , 7 days ,and 14 days |
• Probing depth | Probing depth is the distance from the gingival margin to the base of the sulcus or periodontal pocket, measured using a periodontal probe. | Baseline and 9 months |
• Plaque index | simple method used to record the presence of dental plaque on tooth surfaces. It is commonly called the O'Leary Plaque Control Record (PCR). | Baseline and 9 months |
• Bleeding index | clinical index used to evaluate gingival inflammation by measuring bleeding after gentle probing.
1. A periodontal probe is gently inserted into the gingival sulcus.
2. The probe is moved along the gingival margin with light pressure.
3. The site is observed for bleeding within about 10-30 second | Baseline and 9 months |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- 18-60 years of age
- Patients have hopeless maxillary teeth, a thin buccal plate of bone ≤1 mm and intact overlying soft tissue intact overlying soft tissues in aesthetic zone (EDS-2, Kan classification)
- Periodontally healthy (good oral hygiene)
- Medically controlled patient
- Smokers
- patients with systemic diseases
- history of chemotherapy or radiotherapy within the past 2 years.
- Acute infection
Responsável pelo estudo
RIM MAZEN, Investigador principal, Rim Mazen Ghanem , demonstrator , faculty of dentistry, the British university in Egypt
Contato central do estudo
Contato: Rim M Ghanem, Bachelor degree of dentistry, 0106037279, [email protected]
1 Locais do estudo em 1 países
The British university in Egypt, Cairo, Egypt
Dalia G Ghalwash, Professor, Contato, 0100 5120159, [email protected]
Em recrutamento