NCT05538078

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2023

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

September 9, 2022

Last Update Submit

September 14, 2022

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment Level

    clinical attachment gain by using UNC15 Periodontal probe/ numerical data

    3months

Secondary Outcomes (4)

  • Probing Depth

    3 months

  • plaque index

    3 months

  • Dentinal Hypersensitivity

    7 days

  • Bleeding on Probing visually/numerical data

    3 months

Study Arms (2)

intervention

EXPERIMENTAL

Ozone gel

Drug: Ozone gel

active comparator

ACTIVE COMPARATOR

nonsurgical periodontal treatment(scaling)

Drug: Ozone gel

Interventions

Ozone gelDRUG

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

Also known as: GeliO3,Bioemmei Srl,36100 Vicenza ,Italy
active comparatorintervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. 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.
  • \. The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 3 months of follow-up.
  • \. Smokers. 8. Pregnant females. 9. Any known allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry ,Cairo university

Cairo, Manial, 12311, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39587593DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Abeer A Barahim, BDS

    Master student

    PRINCIPAL INVESTIGATOR

  • Nesma M Shemais, PhD

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

    STUDY DIRECTOR

  • Mona S Darhous, PhD

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

    STUDY CHAIR

Central Study Contacts

Abeer A Barahim, BDS

CONTACT

00201501808068abeer.barahim@dentistry.cu.edu.eg

Nesma M Shemais, PhD

CONTACT

00201005615697nesma.shemais@dentostry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 13, 2022

Study Start

October 15, 2022

Primary Completion

February 10, 2023

Study Completion

August 2, 2023

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

EG(1)