Periodontal DiseasesNCT05538078
Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis
A study testing Ozone gel in people with Periodontal Diseases, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Ozone gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2022to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry ,Cairo university
Cairo, Manial, 12311
Nesma M Shemais, PhD, 00201005615697, nesma.shhemais@dentistry.cu.edu.eg
About this study
Official title: 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.
Read the 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
- Being tested
- Ozone gel
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone gelDrug
Also called GeliO3,Bioemmei Srl,36100 Vicenza ,Italy
application of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Ozone gel Receives: Drug: Ozone gel |
| active comparator | Active comparator | nonsurgical periodontal treatment(scaling) Receives: Drug: Ozone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
clinical attachment gain by using UNC15 Periodontal probe/ numerical data
Measured: 3months
Secondary outcomes (4)
Probing Depth
measuring probing depth by using UNC15 Periodontal probe/numerical data
Measured: 3 months
plaque index
measuring it visually/numerical data
Measured: 3 months
Dentinal Hypersensitivity
measuring it using VAS scale
Measured: 7 days
Bleeding on Probing visually/numerical data
measuring it visually/numerical data
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start15 Oct 2022 (estimated)
- Primary completion10 Feb 2023 (estimated)
- Study completion2 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Abubaker Mohamed Barahim, Cairo University
- Investigators
- Abeer A Barahim, BDS, Principal investigator, Master studentNesma M Shemais, PhD, Study director, Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo universityMona S Darhous, PhD, Study chair, Professor of oral medicine and periodontology factuality of Dentistry,Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538078
- Sponsor's protocol ID
- Ghala
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39587593
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Non-Surgical Therapy With and Without Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT05538078
- Acronym / sponsor ID
- Ghala
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 2 Aug 2023 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: Ozone gelOzone gel |
| active comparator | Active comparator | Drug: Ozone gelnonsurgical periodontal treatment(scaling) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozone gelAlso: GeliO3,Bioemmei Srl,36100 Vicenza ,Italyapplication of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket | Drug | active comparator, intervention |
Primary outcome
Clinical Attachment Level
Time frame: 3months
clinical attachment gain by using UNC15 Periodontal probe/ numerical data
4 secondary outcomes
Probing Depth
Time frame: 3 months
plaque index
Time frame: 3 months
Dentinal Hypersensitivity
Time frame: 7 days
Bleeding on Probing visually/numerical data
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 39587593Barahim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer A Barahim, BDS principal investigator
Master student
Nesma M Shemais, PhD study director
Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university
Mona S Darhous, PhD study chair
Professor of oral medicine and periodontology factuality of Dentistry,Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone gel in people with Periodontal Diseases, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer A Barahim, BDS (00201501808068, abeer.barahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.