Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Drug: Ozone gel

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abeer A Barahim, BDS; Phone Number: 00201501808068; Email: abeer.barahim@dentistry.cu.edu.eg
• Study Contact Backup: Name: Nesma M Shemais, PhD; Phone Number: 00201005615697; Email: nesma.shemais@dentostry.cu.edu.eg

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 12311
      • Recruiting
      • Faculty of dentistry ,Cairo university
      • Contact: Nesma M Shemais, PhD; Phone Number: 00201005615697; Email: nesma.shhemais@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervention; Ozone gel	Drug: Ozone gel; application of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket; Other Names: GeliO3,Bioemmei Srl,36100 Vicenza ,Italy
ACTIVE_COMPARATOR: active comparator; nonsurgical periodontal treatment(scaling)	Drug: Ozone gel; application of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket; Other Names: GeliO3,Bioemmei Srl,36100 Vicenza ,Italy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	3 months
Dentinal Hypersensitivity	measuring it using VAS scale	7 days
Bleeding on Probing visually/numerical data	measuring it visually/numerical data	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Abeer A Barahim, BDS, Master student; Study Director: Nesma M Shemais, PhD, Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university; Study Chair: Mona S Darhous, PhD, Professor of oral medicine and periodontology factuality of Dentistry,Cairo university

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2022
• Primary Completion (ANTICIPATED): February 10, 2023
• Study Completion (ANTICIPATED): August 2, 2023

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (ACTUAL): September 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: Ghala

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No