The Impact of Ozone Gel on the Bone Height and Density

NCT06604819 | Completed DMC

• 1 other identifier: 417/2021
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinus Pneumatization

Keywords

closed sinus lifting

Outcome Measures

Primary Outcomes (1)

• 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 .

  Immediate postoperative,3 months and 4 months postoperative

Secondary Outcomes (2)

• Bone Density

  Immediate postoperative and 4 months postoperative

• Bone height gain

  Immediate postoperative and 4 months postoperative

Study Arms (2)

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 .

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 .

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

Interventions

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 with ozone gel placement

closed sinus lifting using osteotomes with simultaneous implant placement PROCEDURE

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

closed sinus lifting using osteotomes with simultaneous implant placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40229413 DERIVED

Study Officials

• Dina El-Zaefzaf, Masters

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: biostatistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator "Doctorate candidate"

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 20, 2024
• Study Start: December 21, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 20, 2023
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: It will be available after the research is published.
• Access Criteria: It will be available upon request

Locations

EG (1)