Partial Edentulism in the Maxilla or in the Mandible, Tooth Loss
Conditions
Keywords
Immediate implant placement, Dental implants, Mandibular premolars, Autogenous bone graft, Osseointegration, Implant stability, Marginal bone loss
Brief summary
This clinical study aims to evaluate the clinical and radiographic outcomes of immediate dental implant placement in mandibular premolar sites. Patients requiring extraction of mandibular premolars will receive immediate implant placement, with or without autogenous bone grafting, according to the study protocol. When indicated, autogenous bone graft will be harvested using piezosurgery during the implant procedure. Participants will be followed up clinically and radiographically to assess implant stability, marginal bone level changes, and peri-implant tissue conditions over a defined follow-up period. The results of this study may help determine the effectiveness and predictability of immediate implant placement in mandibular premolar regions.
Detailed description
This prospective clinical study is designed to evaluate the clinical and radiographic outcomes of immediate dental implant placement in mandibular premolar regions following tooth extraction. Patients indicated for extraction of mandibular premolars will be enrolled according to predefined inclusion and exclusion criteria. Following atraumatic tooth extraction, immediate dental implant placement will be performed in the extraction socket. two group included, one without bone graft and the other group with autogenous bone graft from ramus . Autogenous bone grafting will be utilized according to the study protocol and will be harvested intraoperatively using piezosurgery to ensure precise and minimally traumatic bone collection. Implant placement will be performed following standard surgical protocols. Primary implant stability will be assessed at the time of placement. Patients will receive postoperative care and instructions according to institutional guidelines. Clinical and radiographic evaluations will be conducted during follow-up visits to assess implant stability, peri-implant soft tissue condition, and marginal bone level changes. Radiographic assessment will be performed using standardized imaging techniques. The primary outcome measures will include implant stability and marginal bone level changes around the implant. Secondary outcome measures will include implant stability and marginal bone level changes around the implant . overall implant success rate. The results of this study aim to provide evidence regarding the predictability and effectiveness of immediate implant placement in mandibular premolar sites, with particular emphasis on the role of autogenous bone graft harvested using piezosurgery.
Interventions
PROCEDUREImmediate implant with autogenous bone graft
Immediate implant with autogenous bone graft using piezo surgery
PROCEDUREImmediate implant without bone graft
Immediate implant without bone graft
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients requiring extraction of mandibular premolars. * Age ≥ 25 years. * Adequate oral hygiene and motivated patients for implant treatment. * Sufficient bone volume to allow immediate implant placement (with or without minor augmentation). * Patients willing to participate and attend follow-up visits for at least 6 months. * Systemically healthy patients (ASA I or II).
Exclusion criteria
* Uncontrolled systemic diseases (e.g., uncontrolled diabetes, immunocompromised patients). * Heavy smokers (e.g., \>10-15 cigarettes/day). * Active periodontal or acute infection at the implant site. * Poor oral hygiene or non-compliant patients. * Pregnancy or lactation. * History of radiotherapy in head and neck region. * Severe bone deficiency not suitable for immediate implant placement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osseointegration success rate (%) | 6 months after implant placement. | Implant success will be evaluated based on the absence of mobility, pain, infection, and peri-implant radiolucency around the implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability (ISQ) | At implant placement and 6 months after implant placement | Implant stability will be measured using resonance frequency analysis (ISQ values) at the time of implant placement and during follow-up. |
| Marginal bone loss (mm) | Baseline (at implant placement) and 4 months after implant placement | Marginal bone level changes around the implant will be assessed using standardized periapical radiographs. Measurements will be performed using Digora software |
| Implant survival rate (%) | 6 months after implant placement | Presence of implant in situ without mobility or failure at follow-up visit. |
| Postoperative complication (%) | Up to 6 months after implant placement. | Clinical assessment of pain, swelling, infection, and delayed healing after implant placement. |
Countries
Egypt
Outcome results
None listed