Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

Not Applicable

Recruiting

• Conditions: Periodontal Diseases
• Interventions: Drug: Ozone gel

• Registration Number: NCT05538078
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-13
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15
• Study Start: 2022-10-15
• Primary Completion: 2023-02-10
• Study Completion: 2023-08-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Ozone gel	Ozone gel
active comparator	Ozone gel	nonsurgical periodontal treatment(scaling)

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	3months	clinical attachment gain by using UNC15 Periodontal probe/ numerical data

Secondary Outcome Measures

Name	Time	Method
Probing Depth	3 months	measuring probing depth by using UNC15 Periodontal probe/numerical data
plaque index	3 months	measuring it visually/numerical data
Dentinal Hypersensitivity	7 days	measuring it using VAS scale
Bleeding on Probing visually/numerical data	3 months	measuring it visually/numerical data

Trial Locations

Locations (1)

Faculty of dentistry ,Cairo university; 🇪🇬 Cairo, Manial, Egypt