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The effect of treatment for gum disease (periodontitis) plus ozone gas therapy on patients with type 2 diabetes

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17281691
Enrollment
200
Registered
2022-07-23
Start date
2018-07-20
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction of oxidative stress in patients with type 2 diabetes via periodontal treatment and ozone therapy Oral Health

Interventions

Subjects receive either periodontal treatment followed by up to 6 sessions of gaseous ozone therapy or periodontal therapy alone

Sponsors

Albanian University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Oxidative stress quantified as the total oxidant status (TOS), total antioxidant status (TAS), nitric oxide (NO) levels, malondialdehyde (MDA) levels, glutathione (L-?-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

MeasureTime frame
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

Countries

Albania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026