Sinus PneumatizationNCT06604819
The Impact of Ozone Gel on the Bone Height and Density
A study testing Ozone gel placed after closed sinus lifting then implant placed simultaneously. and closed sinus lifting using osteotomes with simultaneous implant placement in people with Sinus Pneumatization, run by Suez Canal University at 1 site in Egypt.
Trial summary
Purpose: The present study was conducted to evaluate the effect of using ozone gel with maxillary sinus elevation using tenting technique on the clinical and radiographic outcome of implants placed simultaneously.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Pneumatization
- What is being tested?
- Ozone gel placed after closed sinus lifting then implant placed simultaneously. and closed sinus lifting using osteotomes with simultaneous implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Dec 2021to 20 Dec 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Compliance with all requirements in the study and signing the informed consent.
Who cannot join
- 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.
- Patients with bad oral hygiene.
- Patients who were alcohol and drug abusers.
- Heavy Smoker Patients.
- Patients who went previous sinus lifting surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Ozone Gel on the Bone Height and Density After Closed Sinus Lifting with Simultaneous Implant Placement: a Randomized Controlled Clinical Trial.
Purpose: The present study was conducted to evaluate the effect of using ozone gel with maxillary sinus elevation using tenting technique on the clinical and radiographic outcome of implants placed simultaneously..
Materials and Methods: A total of 30 sinuses with an average residual alveolar bone height ranging from 4-7 mm participated in this randomized controlled clinical trial. After closed sinus lift operation, patients were randomly and equally allocated into control group and ozone gel recipient group. Cone beam computed tomography was performed immediately and at 4 months postoperatively. Bone stability was measured immediately and at 3 \& 4 months postoperatively. Bone height and stability were evaluated radiographically, and bone stability was measured using the Osstell device.
Read the detailed description
Concern over biological augmentations used in bone healing has grown in recent years. One of the essential demands in sinus lifting procedure is to speed up the bone formation and enhance the quality of the formed bone in the space created after sinus elevation. Since more than 100 years medical grade ozone has been used as one of the non-medication methods of treatment. E. A. Fisch in the 1930's was the first dentist to use ozone therapy in his practice to aid in disinfection and wound healing. Current ozone uses a mixture of ozone gel and pure oxygen, with today's medical ozone generators which regulate the flow of medical grade O2 through high voltage tubes which is capable of producing pure ozone-oxygen mixtures in precise dosages.
Nevertheless, there is not enough evidence to support the use of ozone in oral and maxillofacial surgery. Ozone therapy has a therapeutic effect that promotes blood and growth factor supply, aids in wound healing, and may improve bone regeneration . However up till now, no studies were conducted to assess the impact of using ozone gel on bone formation in case maxillary sinus elevation.
- Conditions
- Sinus Pneumatization
- Being tested
- Ozone gel placed after closed sinus lifting then implant placed simultaneously., closed sinus lifting using osteotomes with simultaneous implant placement
- Keywords
- closed sinus lifting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone gel placed after closed sinus lifting then implant placed simultaneously.Drug
The patient received closed sinus lifting using osteotomes then ozone gel is prepared. 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 then implants were placed.
closed sinus lifting using osteotomes with simultaneous implant placementProcedure or surgery
The patient received closed sinus lifting using osteotomes with implant placed simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| closed sinus lifting using osteotomes with simultaneous implant placement | 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 . Receives: Procedure: closed sinus lifting using osteotomes with simultaneous implant placement |
| closed sinus lifting using osteotomes with simultaneous implant placement with ozone gel placement | 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 . Receives: Drug: Ozone gel placed after closed sinus lifting then implant placed simultaneously. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
- Resonance frequency analysis was performed to assess implant stability. The implant stability was measured using the Osstell ISQ scale "immediate postoperative then after 3 and 4 months . The readings were taken along the three surfaces of the implant (perpendicular to the implant axis, mesial surface and distal surface). Finally, the averages of these readings were taken as a representative value for each implant .
Measured: Immediate postoperative,3 months and 4 months postoperative
Secondary outcomes (2)
Bone Density
The bone density was evaluated using CBCT. To minimize the error from radiographic image alignment, the On Demand 3D fusion module software was used to generate a superimposed image at the sagittal and coronal planes of each implant to compare each parameter .
Measured: Immediate postoperative and 4 months postoperative
Bone height gain
Cone beam computed tomography (CBCT was taken to evaluate the accuracy of implant placement and to represent the baseline measurement for evaluation. The bone height gain was evaluated along the surface of each implant.
Measured: Immediate postoperative and 4 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start21 Dec 2021
- Primary completion15 Dec 2022
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinus PneumatizationStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina yousry, Suez Canal University
- Investigators
- Dina El-Zaefzaf, Masters, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604819
- Sponsor's protocol ID
- 417/2021
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available upon request
Publications
Yousry D, Riad R, Soliman RA, ElSholkamy M. Does ozone gel enhance the bone width and buccal plate of bone thickness surrounding the implant following osseodensification? A randomized controlled clinical trial. Oral Maxillofac Surg. 2025 Apr 14;29(1):82. doi: 10.1007/s10006-025-01367-x.
PubMed 40229413
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ozone Gel on the Bone Height and Density After Closed Sinus Lifting with Simultaneous Implant Placement: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06604819
- Acronym / sponsor ID
- 417/2021
- Conditions
- Sinus Pneumatization
- Keywords
- closed sinus lifting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The present study was conducted to evaluate the effect of using ozone gel with maxillary sinus elevation using tenting technique on the clinical and radiographic outcome of implants placed simultaneously..
Materials and Methods: A total of 30 sinuses with an average residual alveolar bone height ranging from 4-7 mm participated in this randomized controlled clinical trial. After closed sinus lift operation, patients were randomly and equally allocated into control group and ozone gel recipient group. Cone beam computed tomography was performed immediately and at 4 months postoperatively. Bone stability was measured immediately and at 3 \& 4 months postoperatively. Bone height and stability were evaluated radiographically, and bone stability was measured using the Osstell device.
Detailed description
Concern over biological augmentations used in bone healing has grown in recent years. One of the essential demands in sinus lifting procedure is to speed up the bone formation and enhance the quality of the formed bone in the space created after sinus elevation. Since more than 100 years medical grade ozone has been used as one of the non-medication methods of treatment. E. A. Fisch in the 1930's was the first dentist to use ozone therapy in his practice to aid in disinfection and wound healing. Current ozone uses a mixture of ozone gel and pure oxygen, with today's medical ozone generators which regulate the flow of medical grade O2 through high voltage tubes which is capable of producing pure ozone-oxygen mixtures in precise dosages.
Nevertheless, there is not enough evidence to support the use of ozone in oral and maxillofacial surgery. Ozone therapy has a therapeutic effect that promotes blood and growth factor supply, aids in wound healing, and may improve bone regeneration . However up till now, no studies were conducted to assess the impact of using ozone gel on bone formation in case maxillary sinus elevation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| closed sinus lifting using osteotomes with simultaneous implant placement | Active comparator | Procedure: closed sinus lifting using osteotomes with simultaneous implant placementFull 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 . |
| closed sinus lifting using osteotomes with simultaneous implant placement with ozone gel placement | Experimental | Drug: Ozone gel placed after closed sinus lifting then implant placed simultaneously.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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Compliance with all requirements in the study and signing the informed consent.
Key exclusion criteria (8 listed)
- 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.
- Patients with bad oral hygiene.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozone gel placed after closed sinus lifting then implant placed simultaneously.The patient received closed sinus lifting using osteotomes then ozone gel is prepared. 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 then implants were placed. | Drug | closed sinus lifting using osteotomes with simultaneous implant placement with ozone gel placement |
| closed sinus lifting using osteotomes with simultaneous implant placementThe patient received closed sinus lifting using osteotomes with implant placed simultaneously. | Procedure or surgery | closed sinus lifting using osteotomes with simultaneous implant placement |
Primary outcome
Implant stability
Time frame: Immediate postoperative,3 months and 4 months postoperative
- Resonance frequency analysis was performed to assess implant stability. The implant stability was measured using the Osstell ISQ scale "immediate postoperative then after 3 and 4 months . The readings were taken along the three surfaces of the implant (perpendicular to the implant axis, mesial surface and distal surface). Finally, the averages of these readings were taken as a representative value for each implant .
2 secondary outcomes
Bone Density
Time frame: Immediate postoperative and 4 months postoperative
Bone height gain
Time frame: Immediate postoperative and 4 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 40229413Yousry D, Riad R, Soliman RA, ElSholkamy M. Does ozone gel enhance the bone width and buccal plate of bone thickness surrounding the implant following osseodensification? A randomized controlled clinical trial. Oral Maxillofac Surg. 2025 Apr 14;29(1):82. doi: 10.1007/s10006-025-01367-x.
- Individual participant dataSharing planned: Yes. It will be available upon request
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Pneumatization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina El-Zaefzaf, Masters principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone gel placed after closed sinus lifting then implant placed simultaneously. and closed sinus lifting using osteotomes with simultaneous implant placement in people with Sinus Pneumatization, 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 8 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 20 Sep 2024. 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.
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 (time frame: Immediate postoperative,3 months and 4 months postoperative). 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 NCT06604819, which also lists 1 linked publication.
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 20 Sep 2024.