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NCT Number: NCT06604819

The Impact of Ozone Gel on the Bone Height and Density

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.

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Key information

Conditions

Sinus Pneumatization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 placement

Procedure

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

Primary outcomes

  1. 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 .

Secondary outcomes

  1. Bone Density

    Time frame: Immediate postoperative and 4 months postoperative

    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 .

  2. Bone height gain

    Time frame: Immediate postoperative and 4 months postoperative

    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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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