The effect of treatment for gum disease (periodontitis) plus ozone gas therapy on patients with type 2 diabetes
| ISRCTN | ISRCTN17281691 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17281691 |
- Submission date
- 18/07/2022
- Registration date
- 23/07/2022
- Last edited
- 15/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
The theory of there being a relationship between inflammatory gum disease (periodontitis) and diabetes explains the variations in glycaemic control in patients with diabetes after periodontal treatment. Likewise, the presence of oxidative stress, a common trigger in the onset of both diseases, had led to the understanding of periodontitis as a risk factor in the progression of diabetes. Ozone therapy, in addition to periodontal treatment, has been demonstrated to be effective in reducing systemic oxidative stress.
Who can participate?
Patients with type 2 diabetes mellitus (T2DM) and generalized periodontitis
What does the study involve?
Subjects will receive either periodontal treatment followed by up to 6 sessions of gaseous ozone therapy or periodontal therapy alone
What are the possible benefits and risks of participating?
The benefit of treatment is an improvement of oxidative status. There are no risks associated with participation in the study.
Where is the study run from?
Albanian University (Albania)
When is the study starting and how long is it expected to run for?
May 2018 to May 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Biagio Rapone (Albania)
biagiorapone79@gmail.com
Contact information
Principal Investigator
Interdisciplinary Department of Medicine
Piazza Giulio Cesare 11
University of Bari Aldo Moro
Bari
70124
Italy
| Phone | +39 3477619817 |
|---|---|
| biagiorapone79@gmail.com |
Study information
| Study design | Double-blinded randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of gaseous ozone therapy in addition to periodontal treatment on oxidative stress in individuals with type 2 diabetes: A double-blinded, randomized clinical trial |
| Study hypothesis | Periodontal treatment plus gaseous ozone therapy reduces oxidative stress in type 2 diabetes patients more than periodontal treatment alone |
| Ethics approval(s) | Approved 16/07/2018, Albanian University Committee (Rruga e Durresit, Tirane I 001 Albania; +355 686086880; e.qorri@albanianuniversity.edu.al), ref: 224 |
| Condition | Reduction of oxidative stress in patients with type 2 diabetes via periodontal treatment and ozone therapy |
| Intervention | Subjects receive either periodontal treatment followed by up to 6 sessions of gaseous ozone therapy or periodontal therapy alone |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gaseous ozone |
| Primary outcome measure | Oxidative stress quantified as the total oxidant status (TOS), total antioxidant status (TAS), nitric oxide (NO) levels, malondialdehyde (MDA) levels, glutathione (L-γ-glutamyl-L-cysteinyl-glycine, GSH) levels measured using a commercially available kit to derive in saliva and a spectrophotometric procedure in blood at baseline, 3, and 6 months |
| Secondary outcome measures | 1. Periodontal depth (PD) measured using a periodontal probe at baseline, 3, and 6 months 2. Clinical attachment level (CAL) measured using a periodontal treatment at baseline, 3, and 6 months 3. Bleeding on Probing (BOP) measured using a periodontal probe at baseline, 3 and 6 months |
| Overall study start date | 10/05/2018 |
| Overall study end date | 17/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 patients per group |
| Total final enrolment | 200 |
| Participant inclusion criteria | 1. Meet the type 2 diabetes mellitus (T2DM) diagnostic criteria recommended by the American Diabetes Association (ADA) in 2020: 1.1. FPG ≥126 mg/dl (7.0 mmol/l), or 2-h PG ≥200 mg/dl (11.1 mmol/l) during OGTT, or HbA1C ≥ 6.5 % (48 mmol/mol), or a random plasma glucose ≥200 mg/dl (11.1 mmol/l) 2. Diagnosis of generalized periodontitis |
| Participant exclusion criteria | 1. Declined cognitive function and unable to make informed consent 2. Underwent periodontal treatment within the last 12 months 3. Systemic antibiotic therapy within the last 6 months 4. Pregnancy or breastfeeding 5. Uncontrolled hypertension 6. History of heart disease or stroke which might interfere with the systemic antioxidative status 7. Active smokers (>10 cigarettes/daily) |
| Recruitment start date | 20/07/2018 |
| Recruitment end date | 13/09/2018 |
Locations
Countries of recruitment
- Albania
Study participating centre
Tirane
001
Albania
Sponsor information
University/education
Rruga e Durresit
Tirana
001
Albania
| Phone | +355 686086880 |
|---|---|
| informacioni@albanianuniversity.edu.al | |
| Website | https://albanianuniversity.edu.al |
"ROR" |
https://ror.org/02f8a6404 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 18/08/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/01/2022 | 13/01/2023 | Yes | No |
| Results article | results | 11/05/2023 | 15/05/2023 | Yes | No |
Editorial Notes
15/05/2023: Publication reference added.
13/01/2023: Publication reference added and total final enrollment amended from 200 to 232.
22/07/2022: Trial's existence confirmed by Albanian University Committee
