Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft on Osseointegration of Immediate Dental Implants
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Suez Canal University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Implant Stability (ISQ)
Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group I (Control Group)
8 implants were inserted immediately after teeth extraction with grafting of injectable β-tricalcium phosphate (β-TCP) bone graft around the implant.
Intervention: Immediate implant placement (Procedure)
Group I (Control Group)
8 implants were inserted immediately after teeth extraction with grafting of injectable β-tricalcium phosphate (β-TCP) bone graft around the implant.
Intervention: β-tricalcium phosphate Injectable Bone Graft (Biological)
Group II (Study Group)
8 implants were inserted immediately after teeth extraction with grafting of ozonated olive oil gel around the implant.
Intervention: Immediate implant placement (Procedure)
Group II (Study Group)
8 implants were inserted immediately after teeth extraction with grafting of ozonated olive oil gel around the implant.
Intervention: Ozonated olive oil gel (Biological)
Outcomes
Primary Outcomes
Implant Stability (ISQ)
Time Frame: 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
Time Frame: 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 Outcomes
- Visual Analogue Scale of Pain (VAS)(Days 1, 3, and 7 postoperatively)
- Visual Scale of Edema(Days 1, 3, and 7 postoperatively)