The Impact of Ozone Gel on the Bone Height and Density

NCT ID: NCT06604819

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2023-12-20

Brief 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..

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.

Conditions

Sinus Pneumatization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

closed sinus lifting using osteotomes with simultaneous implant placement

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 .

Group Type: ACTIVE_COMPARATOR

closed sinus lifting using osteotomes with simultaneous implant placement

Intervention Type: PROCEDURE

The patient received closed sinus lifting using osteotomes with implant placed simultaneously.

closed sinus lifting using osteotomes with simultaneous implant placement with ozone gel placement

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 Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

closed sinus lifting using osteotomes with simultaneous implant placement

The patient received closed sinus lifting using osteotomes with implant placed simultaneously.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Dina yousry

Principle investigator "Doctorate candidate"

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina El-Zaefzaf, Masters

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Locations

Faculty of Dentistry, Suez Canal University

Ismailia, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 40229413 (View on PubMed)

Other Identifiers

417/2021

Identifier Type: -

Identifier Source: org_study_id