Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft

Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft on Osseointegration of Immediate Dental Implants

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 Overview

• Status: Completed
• Conditions: Implant Osseointegration; Bone Graft; Dental; Ozone Therapy
• Intervention / Treatment: Procedure: Immediate implant placement; Biological: β-tricalcium phosphate Injectable Bone Graft; Biological: Ozonated olive oil gel

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Suez Canal University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Immediate implant placement; Placement of a dental implant immediately after tooth extraction in the mandibular premolar region following standard surgical protocol.; Biological: β-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.; Other Names: Control Group; Group I
Experimental: Group II (Study Group); 8 implants were inserted immediately after teeth extraction with grafting of ozonated olive oil gel around the implant.	Procedure: Immediate implant placement; Placement of a dental implant immediately after tooth extraction in the mandibular premolar region following standard surgical protocol.; Biological: Ozonated olive oil gel; Immediate implant placement in the mandibular premolar region with application of ozonated olive oil gel to the peri-implant defect.; Other Names: Study Group; Group II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 3 and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Days 1, 3, and 7 postoperatively

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Chair: Mohamed Said Hamed, Professor, Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University; Principal Investigator: Shimaa Abdallah Metawea, B.D.S, Dentist at Ministry of Health and Population; Study Director: Ahmed Mohamed El Rawdy, Professor, Professor of Oral and Maxillofacial Radiology, Faculty of Dentistry - Suez Canal University; Study Director: Ahmed Abd elmohsen Younis, Assistant. Professor, Assistant. Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

Publications and helpful links

General Publications

• Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
• Botticelli D, Renzi A, Lindhe J, Berglundh T. Implants in fresh extraction sockets: a prospective 5-year follow-up clinical study. Clin Oral Implants Res. 2008 Dec;19(12):1226-32. doi: 10.1111/j.1600-0501.2008.01620.x.
• Abas, M., Ghanem, W., El Desouky, G., El Gerby, Y. (2021). 'Clinical and Radiographic Evaluation of Immediate Implant with Bone Graft (Hyprooss)', Dental Science Updates, 2(1), pp. 17-25.
• Barone S, Zaffino P, Salviati M, Destito M, Antonelli A, Bennardo F, Cevidanes L, Spadea MF, Giudice A. Automated pipeline for linear and volumetric assessment of facial swelling after third molar surgery. BMC Oral Health. 2024 Nov 19;24(1):1404. doi: 10.1186/s12903-024-05193-7.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2023
• Primary Completion (Actual): May 10, 2025
• Study Completion (Actual): September 10, 2025

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Osseointegration; Dental Implants; Ozonated Olive Oil Gel; Injectable Bone Graft
• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 738/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No