Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft

Suez Canal University16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Implant Osseointegration Ozone Therapy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Implant Stability (ISQ)

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.

Time frame: Baseline, and 6 months postoperatively

Bone density

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.

Time frame: Baseline, 3 and 6 months postoperatively

Secondary Outcomes

Visual Analogue Scale of Pain (VAS)

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.

Time frame: Days 1, 3, and 7 postoperatively

Visual Scale of Edema

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).