Bone Graft, Dental, Implant Osseointegration, Ozone Therapy
Conditions
Keywords
Osseointegration, Dental Implants, Ozonated Olive Oil Gel, Injectable Bone Graft
Brief summary
Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. The aim of this study is to evaluate clinically and radiographically the efficacy of injectable bone graft versus ozonated olive oil gel to promote bone formation and improve outcomes in immediate implant cases. 16 immediate implants will be placed in mandibular premolar region the study will be devided equally and randomlly into two groups , Group 1: it will be 8 immediate implants represent the control group were the implants will be placed with injectable bone graft , Group 2: will be 8 immediate implant represent the study group were the implants will be placed with ozonated olive oil gel be used as a graft material . The implant stability will be assessed clinically using Ostell , and the bone density will be assed radiographically .
Interventions
PROCEDUREImmediate implant placement
Placement of a dental implant immediately after tooth extraction in the mandibular premolar region following standard surgical protocol.
BIOLOGICALβ-tricalcium phosphate Injectable Bone Graft
Immediate implant placement in the mandibular premolar region with application of injectable bone graft material to the peri-implant defect.
BIOLOGICALOzonated olive oil gel
Immediate implant placement in the mandibular premolar region with application of ozonated olive oil gel to the peri-implant defect.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
16 immediate implants will be placed in the mandibular premolar region, divided randomly into two groups: Group 1 (control) will use injectable bone graft for 8 implants, while Group 2 (study) will use ozonated olive oil gel as graft material for the other 8 implants.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged between 20 and 60 years. * Adults of both genders. * Patients who are medically healthy and without systemic conditions that could contraindicate implant placement. * Patients requiring extraction of a single unrestorable mandibular premolar indicated for immediate implant placement. * Presence of sufficient apical and peripheral bone to achieve primary implant stability (minimum 3-5 mm of bone beyond the socket apex and overall socket length ≥ 10 mm).
Exclusion criteria
* Pregnant and lactating women's * Heavy smoking (\>10 cigarettes/day) * Severe parafunctional habits (e.g., uncontrolled bruxism). * Periapical infections or lesions. * Gingival and periodontal diseases. * Inability or unwillingness to attend scheduled follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Stability (ISQ) | Baseline, and 6 months postoperatively | Osstell enables precise and objective monitoring of osseointegration and implant stability through non-invasive measurements. A cable-connected probe requires a smart peg to be securely attached to the implant. When using the device, it should be held at a right angle to the implant, with a maximum deviation of 45 degrees and a distance of 0.6-2.5 mm from the test surface. The implant stability is measured using the ISQ scale, ranging from 1 to 100, where values above 70 indicate strong stability, 60-69 indicate medium stability, and lower values suggest lower stability. Measurements are taken immediately postoperatively and reassessed after 6 months for final stability confirmation. |
| Bone density | Baseline, 3 and 6 months postoperatively | Direct paralleling digital periapical radiographs were obtained using the KaVo Scan eXam™ One system and the Rinn extension cone paralleling device. The KaVo system employs a thin, flexible, wireless phosphorescent imaging plate, and the imaging plate size 2 has a specific active surface area and resolution. A long cone was attached to the x-ray tube, and fixed exposure parameters were applied throughout the study. Radiographic assessments occurred immediately post-operative and after 3 and 6 months. Image analysis utilized IDRISI Kilimanjaro software for restoration, enhancement, and densitometric measurements. This software uniquely monitored changes in bone density in two zones: the osseointegration zone near the implant border and the surrounding bone interface. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale of Pain (VAS) | Days 1, 3, and 7 postoperatively | The Visual Analog Scale (VAS) is a widely utilized instrument for quantifying pain intensity in clinical settings. It features a 10-centimeter horizontal line marked at both ends to represent the range of possible pain experiences, where one end is typically labeled "no pain" and the opposite end may carry descriptors such as "unimaginably unspeakable pain." Patients are instructed to indicate their pain level by placing a mark on the line that corresponds to their current pain experience. The measurement in centimeters from the "no pain" endpoint to the patient's designated point provides a straightforward numerical representation of pain severity. This method is favored for its simplicity and its ability to yield quantifiable data, facilitating better pain assessment and management in various medical contexts. |
| Visual Scale of Edema | Days 1, 3, and 7 postoperatively | Facial edema was assessed using a clinical grading scale based on visual inspection and palpation, classifying it into four severity categories: No Edema (normal contours and symmetry), Low-grade Edema (mild swelling without functional limitations), Intermediate-grade Edema (moderate swelling with visible asymmetry and slight discomfort), and High-grade Edema (pronounced swelling with evident asymmetry and significant functional interference). |
Countries
Egypt
Contacts
STUDY_CHAIRMohamed Said Hamed, Professor
Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University
PRINCIPAL_INVESTIGATORShimaa Abdallah Metawea, B.D.S
Dentist at Ministry of Health and Population
STUDY_DIRECTORAhmed Mohamed El Rawdy, Professor
Professor of Oral and Maxillofacial Radiology, Faculty of Dentistry - Suez Canal University
STUDY_DIRECTORAhmed Abd elmohsen Younis, Assistant. Professor
Assistant. Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University
Outcome results
None listed