Clinical trial NCT06604819: The Impact of Ozone Gel on the Bone Height and Density
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Pneumatization
Keywords: closed sinus lifting
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&amp; 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.

Eligibility criteria: Inclusion Criteria:

* Patient age should be \&gt; 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.

Primary outcomes:
measure: Implant stability
timeFrame: Immediate postoperative,3 months and 4 months postoperative
Secondary outcomes:
measure: Bone Density
timeFrame: Immediate postoperative and 4 months postoperative
measure: Bone height gain
timeFrame: Immediate postoperative and 4 months postoperative
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Faculty of Dentistry, Suez Canal University
Study officials:
affiliation: Suez Canal University
name: Dina El-Zaefzaf, Masters
role: PRINCIPAL_INVESTIGATOR
References: