Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft

Suez Canal University

Status and phase: Completed; Phase 2

Conditions: Dental; Ozone Therapy; Implant Osseointegration; Bone Graft

Treatments: Procedure: Immediate implant placement; Biological: Ozonated olive oil gel; Biological: β-tricalcium phosphate Injectable Bone Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT07368114

738/2023

Details and patient eligibility

About

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 .

Enrollment: 16 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group I (Control Group)

Active Comparator group

Description:

8 implants were inserted immediately after teeth extraction with grafting of injectable β-tricalcium phosphate (β-TCP) bone graft around the implant.

Treatment:

Biological: β-tricalcium phosphate Injectable Bone Graft

Procedure: Immediate implant placement

Group II (Study Group)

Experimental group

Description:

8 implants were inserted immediately after teeth extraction with grafting of ozonated olive oil gel around the implant.

Treatment:

Biological: Ozonated olive oil gel

Procedure: Immediate implant placement