Periodontal Diseases
Conditions
Keywords
Periodontitis, Periodontal treatment, diabetes
Brief summary
The goal of this clinical trial is to evaluate the use of ozone oil as an adjunctive of non-surgical periodontal treatment (NSPT) on diabetics type 2 patients (DM2) compared to control group with chronic periodontal disease. The principal question is to evaluate if the ozone oil could improve periodontal clinical parameters. Thirty-two sites of 16 diabetics type 2 patients (DM2) with moderate to advanced periodontal disease containing two sites with periodontal pocket depth (PPD) of \> 5 mm were selected. The treatment was distributed in 2 groups in the split mouth design: Control- scaling and root planing + saline solution (control) and Test - scaling and root planning + ozone oil
Interventions
DRUGtest
Ozone oil used as an adjunctive of scaling and root planing and control,
DRUGControl
saline solution 0.09% used as an adjunctive as scaling and root planing
Sponsors
Universidade Federal Fluminense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants - The randomization performed will use the coin heads or tails method, Investigators -Two treatments at randomly chosen sites separate in two groups: Ozone oil use as an adjunctive of scaling and root planing and saline solution 0.09%, as a control, associate as an adjunctive of scaling and root planing. Ultrasonic scaler and Gracey curets use to remove all calculus and biofilms during scaling and root planing. The oils are numbere syringes labeled 1 and 2 for blinded applications, and 1 ml of each oil were administrated in a previous selected site. After removing baseline samples of biofilm, the scaling and root planing were performed using ultrasonic devices and manual Gracey curettes.
Intervention model description
This is a prospective clinical randomized controlled, split mouth designed, doble blinded study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Periodontitis * Systemic type 2 diabetes
Exclusion criteria
* Hypersensitivity to ozone oil * Osteoporosis types I and II * Alcoholism * Immunosuppressio * Pregnant and lactating * Physical/emotional stress drugs * Use of antibiotics, anti-inflammatories and hormone * Oral candidiasis * Received periodontal treatment in the last six months prior to the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical attachment level | baseline | mm |
| Plaque Index | baseline | Percentage |
| Gingival Index | baseline | Percentage |
| Probing Depth | baseline | mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | 3 months | Percentage |
| Gingival Index | 3 months | Percentage |
| Probing Depth | 3 months | mm |
| clinical attachment levels | 3 months | mm |
Countries
Brazil
Outcome results
None listed