Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis
Primary Purpose
Periodontal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ozone gel
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
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
Sites / Locations
- Faculty of dentistry ,Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention
active comparator
Arm Description
Ozone gel
nonsurgical periodontal treatment(scaling)
Outcomes
Primary Outcome Measures
Clinical Attachment Level
clinical attachment gain by using UNC15 Periodontal probe/ numerical data
Secondary Outcome Measures
Probing Depth
measuring probing depth by using UNC15 Periodontal probe/numerical data
plaque index
measuring it visually/numerical data
Dentinal Hypersensitivity
measuring it using VAS scale
Bleeding on Probing visually/numerical data
measuring it visually/numerical data
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05538078
Brief Title
Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis
Official Title
Clinical and Radiographic Evaluation of Non-Surgical Therapy With and Without Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Anticipated)
Primary Completion Date
February 10, 2023 (Anticipated)
Study Completion Date
August 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
Ozone gel
Arm Title
active comparator
Arm Type
Active Comparator
Arm Description
nonsurgical periodontal treatment(scaling)
Intervention Type
Drug
Intervention Name(s)
Ozone gel
Other Intervention Name(s)
GeliO3,Bioemmei Srl,36100 Vicenza ,Italy
Intervention Description
application of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket
Primary Outcome Measure Information:
Title
Clinical Attachment Level
Description
clinical attachment gain by using UNC15 Periodontal probe/ numerical data
Time Frame
3months
Secondary Outcome Measure Information:
Title
Probing Depth
Description
measuring probing depth by using UNC15 Periodontal probe/numerical data
Time Frame
3 months
Title
plaque index
Description
measuring it visually/numerical data
Time Frame
3 months
Title
Dentinal Hypersensitivity
Description
measuring it using VAS scale
Time Frame
7 days
Title
Bleeding on Probing visually/numerical data
Description
measuring it visually/numerical data
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abeer A Barahim, BDS
Phone
00201501808068
Email
abeer.barahim@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Nesma M Shemais, PhD
Phone
00201005615697
Email
nesma.shemais@dentostry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer A Barahim, BDS
Organizational Affiliation
Master student
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nesma M Shemais, PhD
Organizational Affiliation
Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mona S Darhous, PhD
Organizational Affiliation
Professor of oral medicine and periodontology factuality of Dentistry,Cairo university
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of dentistry ,Cairo university
City
Cairo
State/Province
Manial
ZIP/Postal Code
12311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesma M Shemais, PhD
Phone
00201005615697
Email
nesma.shhemais@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis
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