Ozone Gel Application in Controlled Type 2 Diabetic Patie... | NCT05538078

Studies
Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

NCT05538078

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 15, 2022Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Periodontal Diseases

Interventions

Ozone gel

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2022Estimated

Primary Completion Date

Feb 10, 2023Estimated

Completion Date

Aug 2, 2023Estimated

First Submitted Date

Sep 9, 2022

First Submission Date that Met QC Criteria

Sep 9, 2022

First Posted Date

Sep 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2022

Last Update Posted Date

Sep 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The adjunctive topical subgingival application ozone gel creates a great improvements in the clinical, bacteriological and immunological parameters over the gold standard of periodontal pocket treatment alone.

Detailed Description

The aim of this study is to compare the effect of using ozone gel as a locally delivered adjunct to scaling and root planning versus scaling and root planning alone on the clinical parameters in stageIII grade B in periodontitis patients with controlled diabetic patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental	Ozone gel	Drug: Ozone gel
active comparator	Active Comparator	nonsurgical periodontal treatment(scaling)	Drug: Ozone gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ozone gel	Drug	application of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket	active comparator intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Attachment Level	clinical attachment gain by using UNC15 Periodontal probe/ numerical data	3months

Secondary Outcomes

Measure	Description	Time Frame
Probing Depth	measuring probing depth by using UNC15 Periodontal probe/numerical data	3 months
plaque index	measuring it visually/numerical data

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with controlled diabetic type II. (HgA1C <7) (Mori et al., 2021)
Adult patients above 18 years old.
Patients with stage III and grade B periodontitis.
Patients accept 3-months follow-up period (cooperative patients).
Patients provide an informed consent

Exclusion Criteria:

1. Presence of prosthetic crowns. 2. Extensive restorations. 3. Periodontal therapy within the last 12 months. 4. Having surgical therapy or undergoing orthodontic treatment. 5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.

6. The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 3 months of follow-up.

7. Smokers. 8. Pregnant females. 9. Any known allergies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abeer A Barahim, BDS	Contact	00201501808068		abeer.barahim@dentistry.cu.edu.eg
Nesma M Shemais, PhD	Contact	00201005615697		nesma.shemais@dentostry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Abeer A Barahim, BDS	Master student	Principal Investigator
Nesma M Shemais, PhD	Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of dentistry ,Cairo university	Recruiting	Cairo	Manial	12311	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39587593	Derived	Barahim AA, Shemais N, Mousa A, Darhous M. Clinical and radiographic evaluation of non-surgical therapy with and without ozone gel application in controlled type 2 diabetic patients with periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2024 Nov 25;24(1):1435. doi: 10.1186/s12903-024-05212-7.

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases