Viewing Study NCT06604819



Ignite Creation Date: 2024-10-26 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06604819
Status: COMPLETED
Last Update Posted: None
First Post: 2024-09-11

Brief Title: The Impact of Ozone Gel on the Bone Height and Density
Sponsor: None
Organization: None

Study Overview

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
Status: COMPLETED
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 1930s 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 todays 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None