Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

NCT ID: NCT05538078

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-08-02

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention

Ozone gel

Group Type: EXPERIMENTAL

Ozone gel

Intervention Type: DRUG

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

active comparator

nonsurgical periodontal treatment(scaling)

Group Type: ACTIVE_COMPARATOR

Ozone gel

Intervention Type: DRUG

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

Interventions

Ozone gel

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

Intervention Type: DRUG

Other Intervention Names

GeliO3,Bioemmei Srl,36100 Vicenza ,Italy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abeer Abubaker Mohamed Barahim

Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abeer A Barahim, BDS

Role: PRINCIPAL_INVESTIGATOR

Master student

Nesma M Shemais, PhD

Role: STUDY_DIRECTOR

Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university

Mona S Darhous, PhD

Role: STUDY_CHAIR

Professor of oral medicine and periodontology factuality of Dentistry,Cairo university

Locations

Faculty of dentistry ,Cairo university

Cairo, Manial, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abeer A Barahim, BDS

Role: CONTACT

abeer.barahim@dentistry.cu.edu.eg

00201501808068

Nesma M Shemais, PhD

Role: CONTACT

nesma.shemais@dentostry.cu.edu.eg

00201005615697

Facility Contacts

Nesma M Shemais, PhD

Role: primary

nesma.shhemais@dentistry.cu.edu.eg

00201005615697

References

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.

Reference Type: DERIVED

PMID: 39587593 (View on PubMed)

Other Identifiers

Ghala

Identifier Type: -

Identifier Source: org_study_id