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To evaluate effectiveness of teeth cleaning alone and with adjunctive use of a gel which releases oxygen in patients suffering from gum disease and type-2 diabetes mellitus - A randomized controlled clinical trial

To evaluate effectiveness of oxygen releasing gel as an adjunct to non-surgical periodontal therapy on salivary and serum chemerin and interleukin-6 levels in patients of periodontitis with type 2 diabetes mellitus- A randomized controlled clinical trial - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077532
Enrollment
40
Registered
2024-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Oxygen releasing gel Blue M gel ( Along with scaling and root planing): patients of periodontitis with Type 2 diabetes mellitus who will receive non-surgical periodontal therapy (Scali

Sponsors

All India Institute of Medical Sciences Bathinda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Stage 2 or 3 and Grade B or C Periodontitis patients. 2. Patients with type 2 diabetes mellitus diagnosed atleast from 1 year. 3. HbA1c 6.5 % . 4. Patients on oral hypoglycaemic agents. 5. No periodontal treatment received from last 6 months. 6. Pocket depth of 4mm on atleast 2 site. 7. A total of at least 20 teeth should be present in dentition.

Exclusion criteria

Exclusion criteria: 1.Current or former smoker. 2.Alcoholic patient. 3.Patient with any other systemic disease. 4.Patients with cancer or history of chemotherapy or radiotherapy. 5.Pregnant and lactating females 6.Patients on Antibiotics, anti-inflammatory drugs from last 6 months. 7.Patients on insulin therapy.

Design outcomes

Primary

MeasureTime frame
1. Clinical outcome - Clinical attachment level (CAL), Gingival index , Probing Depth (PD), Plaque index. 2. Immunological outcome - Chemerin and interleukin-6 concentration in saliva and serum. Timepoint: baseline, 8 weeks, 12 weeks

Secondary

MeasureTime frame
1. Biochemical outcome - HbA1c levels in blood.Timepoint: baseline, 12 weeks

Countries

India

Contacts

Public ContactDr Mehak gupta

All India Institute of Medical Sciences Bathinda

latagoyal83@gmail.com8475000284

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026