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AzTrials

DentalPhase 2NCT07368114

Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft

A Phase 2 study testing Immediate implant placement, β-tricalcium phosphate Injectable Bone Graft and Ozonated olive oil gel in people with Dental and Implant Osseointegration, run by Suez Canal University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Dental, Implant Osseointegration, Ozone Therapy
What is being tested?
Immediate implant placement, β-tricalcium phosphate Injectable Bone Graft and Ozonated olive oil gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteEgypt
Study dates
10 Dec 2023to 10 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Egypt1 site

  • Suez Canal University, Faculty of Dentistry

    Ismailia

Other trials in Egypt

About this study

Official title: 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 .

Being tested
Immediate implant placement, β-tricalcium phosphate Injectable Bone Graft, Ozonated olive oil gel
Keywords
Osseointegration, Dental Implants, Ozonated Olive Oil Gel, Injectable Bone Graft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate implant placementProcedure or surgery

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

  • β-tricalcium phosphate Injectable Bone GraftBiological

    Also called Group I, Control Group

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

  • Ozonated olive oil gelBiological

    Also called Group II, Study Group

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

Study groups in NCT07368114
Study groupRoleWhat they receive
Group I (Control Group)Active comparator8 implants were inserted immediately after teeth extraction with grafting of injectable β-tricalcium phosphate (β-TCP) bone graft around the implant.
Receives: Procedure: Immediate implant placement; Biological: β-tricalcium phosphate Injectable Bone Graft
Group II (Study Group)Experimental8 implants were inserted immediately after teeth extraction with grafting of ozonated olive oil gel around the implant.
Receives: Procedure: Immediate implant placement; Biological: Ozonated olive oil gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, and 6 months postoperatively

  2. 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.

    Measured: Baseline, 3 and 6 months postoperatively

Secondary outcomes (2)

  1. 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.

    Measured: Days 1, 3, and 7 postoperatively

  2. 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).

    Measured: Days 1, 3, and 7 postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start10 Dec 2023
  3. Primary completion10 May 2025
  4. Study completion10 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07368114
Sponsor's protocol ID
738/2023
Status last verified
Oct 2023
First submitted
8 Jan 2026
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 19040437

  • 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.

    PubMed 24049221

  • 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.

    PubMed 39563399

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Immediate implant placement, β-tricalcium phosphate Injectable Bone Graft and Ozonated olive oil gel in people with Dental and Implant Osseointegration, run by Suez Canal University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Stability (ISQ) (time frame: Baseline, and 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07368114, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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