Completed

Ozone Gel for Bone Height and Density After Sinus Lifting

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What is being tested

Ozone gel placed after closed sinus lifting then implant placed simultaneously.

+ closed sinus lifting using osteotomes with simultaneous implant placement

DrugProcedure
Who is being recruted

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2021
See protocol details

Summary

Principal SponsorSuez Canal University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 21, 2021

Actual date on which the first participant was enrolled.

This clinical trial explores the use of ozone gel to improve bone healing in dental procedures involving sinus lifting and implant placement. Sinus lifting is a surgical procedure that helps prepare the upper jaw for dental implants by increasing bone height and density. Enhancing bone formation in this area is crucial, and ozone gel, known for its medical applications for over a century, is being tested for its potential benefits. This study is important as it seeks to provide evidence on using ozone gel in oral surgeries, which could lead to better outcomes for patients undergoing these procedures. Participants in this study will undergo a sinus lifting procedure, during which ozone gel will be applied to the treatment site. This gel is a mixture of ozone and pure oxygen designed to enhance blood flow, promote healing, and potentially improve bone regeneration. The study will measure changes in bone height and density to determine the effectiveness of ozone gel. Although ozone therapy is believed to aid healing, this trial aims to gather concrete evidence on its benefits in dental surgery, contributing to safer and more effective treatment options.

Official TitleThe Impact of Ozone Gel on the Bone Height and Density After Closed Sinus Lifting with Simultaneous Implant Placement: a Randomized Controlled Clinical Trial.
NCT06604819
Principal SponsorSuez Canal University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Patient age should be > 18 years of age.
Patients included were ASA I and ASA II.
Both males and females were included in the study.
Patients with need of tooth replacements in the maxillary premolar and molar area where the residual alveolar bone height ranges from 4-7 mm and bone density D3 or D4.
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8 exclusion criteria prevent from participating
Patients with immunological diseases or diseases affecting bone healing.
Patients suffering from uncontrolled systemic diseases.
Patients with active acute infection related to the planned implant site, maxillary sinusitis or pathosis.
Patients with parafunctional occlusal habits.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Full thickness mucoperiosteal flap was elevated.• The pilot drill of the implant system was used to create an osteotomy 1 mm short of the subantral floor. • The insertion of the osteotome were repeated several times until the required membrane lift was achieved then the osteotome corresponding in size to the last drill was used.Ozone gel was delivered into the osteotomy . To obtain the ozone gel, pure olive oil was blasted with 25 μ/ml O3 gas for two days, or until the oil changed from a greenish-colored liquid to a whitish gel. The longevity Ext 120 ozone generator executed out this process. After that, placement of the implant was done .Healing abutment was placed to allow for multiple times measurements of implant stability and primary closure was done and the flap was sutured in an interrupted manner using 4/0 prolene suture .

Group II

Active Comparator
Full thickness mucoperiosteal flap was elevated.• The pilot drill of the implant system was used to create an osteotomy 1 mm short of the subantral floor. • The insertion of the osteotome were repeated several times until the required membrane lift was achieved then the osteotome corresponding in size to the last drill was used.After that, placement of the implant was done .Healing abutment was placed to allow for multiple times measurements of implant stability and primary closure was done and the flap was sutured in an interrupted manner using 4/0 prolene suture .

Study Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Faculty of Dentistry, Suez Canal University

Ismailia, EgyptOpen Faculty of Dentistry, Suez Canal University in Google Maps
CompletedOne Study Center