- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07610876
Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration
Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Patients requiring extraction and immediate implant placement in the maxillary premolar region often present with peri-implant defects and jumping gaps that may compromise osseointegration and long-term implant success. Autogenous bone grafts are considered the gold standard for bone augmentation because of their osteogenic, osteoinductive, and osteoconductive properties; however, they are associated with donor-site morbidity, limited availability, and increased surgical time. Recently, autologous demineralized dentin graft (ADDG) derived from extracted teeth has been introduced as a promising alternative grafting material due to its chemical and histological similarity to alveolar bone.
Dentin and bone share a common embryologic origin and similar composition, including type I collagen and low crystalline hydroxyapatite. Demineralized dentin graft material has demonstrated favorable osteoconductive and osteoinductive properties and has been successfully used in guided bone regeneration and immediate implant procedures. In immediate implant placement, the extracted tooth may be processed and reused as graft material to fill the jumping gap around the implant.
Melatonin (N-acetyl-5-methoxytryptamine) is an antioxidant molecule that has demonstrated beneficial effects on bone metabolism and osseointegration. Melatonin reduces osteoclastic activity, promotes osteoblast differentiation, enhances bone formation, and decreases oxidative stress during healing. Previous studies have suggested that local application of melatonin around dental implants may improve early osseointegration and bone healing.
The purpose of this randomized clinical study is to evaluate clinically and radiographically the effect of using melatonin gel in conjunction with autologous demineralized dentin graft on the osseointegration of immediately placed implants.
Thirty patients with non-restorable maxillary premolar teeth indicated for extraction and immediate implant placement will be recruited from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Eligible patients will be randomly allocated into two equal groups. In Group I, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft alone. In Group II, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft mixed with melatonin gel.
Clinical assessment will include implant stability measurement using the Penguin device, peri-implant sulcus depth, and modified bleeding on probing index. Radiographic evaluation will be performed using cone beam computed tomography (CBCT) to assess buccal bone thickness, crestal Bone Height, jumping distance, and bone density at baseline, immediately after implant placement, and during follow-up periods up to 9 months postoperatively.
The results of this study may help determine whether the addition of melatonin gel to autologous demineralized dentin graft improves osseointegration and peri-implant bone healing in immediate implant placement procedures.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: B.S.D Abd El Fattah ELSaid Attia
- Número de teléfono: +20100465932
- Correo electrónico: PGS.230043@dent.suez.edu.eg
Ubicaciones de estudio
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Ismailia, Egipto
- Reclutamiento
- Suez Canal University, Faculty of Dentistry
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Contacto:
- Dean, Faculty of Dentistry, Suez Canal University
- Número de teléfono: (+2064) 3223007
- Correo electrónico: President_office@suez.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age above 20 years
- Non-restorable maxillary premolar teeth
- Candidates for immediate implant placement
- Intact socket walls
- Jumping gap >2 mm
- Non-smokers or light smokers
- No acute infection
- Adequate bone for primary stability
Exclusion Criteria:
- Heavy smokers
- Bruxism or clenching
- Uncontrolled systemic disease
- Chemotherapy/radiotherapy
- Immunocompromised patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ADDG Alone
Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) alone after extraction of non-restorable teeth.
Clinical and radiographic evaluation will be performed during the follow-up period.
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Autologous demineralized dentin graft prepared from extracted non-restorable teeth will be used for filling the jumping gap around immediately placed dental implants.
Tooth preparation includes removal of restorations, caries, periodontal ligament, pulp tissue, calculus, and cementum, followed by grinding and demineralization using 2% nitric acid before graft placement.
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Experimental: ADDG + Melatonin Gel
Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) mixed with melatonin gel after extraction of non-restorable teeth.
Clinical and radiographic evaluation will be performed during the follow-up period.
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Melatonin gel will be mixed with autologous demineralized dentin graft and used for filling the jumping gap around immediately placed dental implants in the maxillary premolar region to enhance osseointegration and peri-implant bone healing.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Implant Stability Quotient (ISQ)
Periodo de tiempo: Baseline and 6 months
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Measured using Penguin device immediately after implant placement and after 6 months.
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Baseline and 6 months
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Jumping Distance
Periodo de tiempo: Immediate postoperative and 9 months after implant placement
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The horizontal bucco-implant gap (jumping distance) will be measured radiographically using CBCT at 0 mm, 2 mm, and 5 mm apical to the implant shoulder as the perpendicular distance from the implant surface to the inner buccal bone plate.
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Immediate postoperative and 9 months after implant placement
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Bone Density
Periodo de tiempo: Immediate postoperative and 9 months after implant placement
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Bone density around the implant will be measured radiographically using CBCT and expressed in Hounsfield units (HU) to evaluate peri-implant bone maturation and osseointegration.
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Immediate postoperative and 9 months after implant placement
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peri-Implant Sulcus Depth (PISD)
Periodo de tiempo: Baseline, 6 months, and 9 months
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Peri-implant sulcus depth will be measured clinically using a periodontal probe at the buccal, palatal, mesial, and distal aspects around the implant.
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Baseline, 6 months, and 9 months
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Modified Bleeding on Probing Index (MBOP)
Periodo de tiempo: Baseline, 6 months, and 9 months
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Modified bleeding on probing index will be recorded clinically using a periodontal probe to evaluate peri-implant soft tissue inflammation around the implant.
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Baseline, 6 months, and 9 months
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Buccal Bone Thickness (BBT)
Periodo de tiempo: Immediate postoperative, and 9 months after implant placement
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Buccal bone thickness will be measured radiographically using standardized CBCT scans at 0 mm, 2 mm, and 5 mm apical to the implant shoulder to evaluate horizontal buccal bone dimensional changes around immediately placed implants.
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Immediate postoperative, and 9 months after implant placement
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Crestal Bone Height (CBH)
Periodo de tiempo: Baseline (immediately after implant placement) and 9-month follow-up
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CBH was measured from the implant platform to the most coronal crestal bone at the mesial, distal, buccal, and palatal aspects using standardized CBCT images.
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Baseline (immediately after implant placement) and 9-month follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Hany Kamel Shalaby, Professor of Oral Medicine and Periodontology, Dean Faculty of Dentistry
- Director de estudio: Shaima Mohammed Morsy, Assistant Professor of Oral Medicine and Periodontology
- Director de estudio: Rasha El-Sayed Afifi, Lecturer of Oral Medicine and Periodontology
- Investigador principal: Abd El Fattah ELSaid Attia, B.S.D, B.S.D
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 854/2024
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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