Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

Periodontal Diseases Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Non-Surgical Therapy With and Without Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538078
• Other study ID #: Ghala
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: August 2, 2023

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: Abeer A Barahim, BDS
• Phone: 00201501808068
• Email: abeer.barahim[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient with controlled diabetic type II. (HgA1C <7) (Mori et al., 2021)

2. Adult patients above 18 years old.

3. Patients with stage III and grade B periodontitis.

4. Patients accept 3-months follow-up period (cooperative patients).

5. 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

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• Ozone gel
application of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket

Locations

Country	Name	City	State
Egypt	Faculty of dentistry ,Cairo university	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Level	clinical attachment gain by using UNC15 Periodontal probe/ numerical data	3months
Secondary	Probing Depth	measuring probing depth by using UNC15 Periodontal probe/numerical data	3 months
Secondary	plaque index	measuring it visually/numerical data	3 months
Secondary	Dentinal Hypersensitivity	measuring it using VAS scale	7 days
Secondary	Bleeding on Probing visually/numerical data	measuring it visually/numerical data	3 months