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

Not Applicable

Completed

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

• Registration Number: ISRCTN17281691
• Lead Sponsor: Albanian University

Brief Summary

2022 Results article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8775443/ results (added 13/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37170229/ results (added 15/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-17
• Study Start: 2022-07-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Periodontal depth (PD) measured using a periodontal probe at baseline, 3, and 6 months<br>2. Clinical attachment level (CAL) measured using a periodontal treatment at baseline, 3, and 6 months<br>3. Bleeding on Probing (BOP) measured using a periodontal probe at baseline, 3 and 6 months