Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft

NCT07368114 | Completed Phase 2

• 1 other identifier: 738/2023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 .

Conditions

Dental; Implant Osseointegration; Ozone Therapy; Bone Graft

Keywords

Osseointegration; Dental Implants; Ozonated Olive Oil Gel; Injectable Bone Graft

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Visual Analogue Scale of Pain (VAS)

  Days 1, 3, and 7 postoperatively

• Visual Scale of Edema

  Days 1, 3, and 7 postoperatively

Study Arms (2)

Group I (Control Group)

ACTIVE COMPARATOR

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; Biological: β-tricalcium phosphate Injectable Bone Graft

Group II (Study Group)

EXPERIMENTAL

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

Procedure: Immediate implant placement; Biological: Ozonated olive oil gel

Interventions

β-tricalcium phosphate Injectable Bone Graft BIOLOGICAL

Immediate implant placement in the mandibular premolar region with application of injectable bone graft material to the peri-implant defect.

Also known as: Group I, Control Group

Group I (Control Group)

Immediate implant placement PROCEDURE

Placement of a dental implant immediately after tooth extraction in the mandibular premolar region following standard surgical protocol.

Group I (Control Group); Group II (Study Group)

Ozonated olive oil gel BIOLOGICAL

Immediate implant placement in the mandibular premolar region with application of ozonated olive oil gel to the peri-implant defect.

Also known as: Group II, Study Group

Group II (Study Group)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Location

Related Publications (4)

• 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.

  PMID: 19040437 BACKGROUND

• 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.

  PMID: 24049221 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 39563399 RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mohamed Said Hamed, Professor

  Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

  STUDY CHAIR

• Shimaa Abdallah Metawea, B.D.S

  Dentist at Ministry of Health and Population

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 26, 2026
• Study Start: December 10, 2023
• Primary Completion: May 10, 2025
• Study Completion: September 10, 2025
• Last Updated: January 26, 2026

Record last verified: 2023-10

Locations

EG (1)