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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Scaling and root planing + saline solution gel (control) will be adminster at probing depth > 5mm. |
|
| Test | Active Comparator | Scaling and root planing + Ozone Oil will be adminster at probing depth > 5mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test | Drug | Ozone oil used as an adjunctive of scaling and root planing and control, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | Percentage | baseline |
| Gingival Index | Percentage | baseline |
| Probing Depth | mm | baseline |
| clinical attachment level | mm | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | Percentage | 3 months |
| Gingival Index | Percentage | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
patients over 18 years old
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriela Alessandra da Cruz Galhardo Camargo | Recruiting | Nova Friburgo | Rio de Janeiro | 28625650 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29265454 | Background | Mauri-Obradors E, Merlos A, Estrugo-Devesa A, Jane-Salas E, Lopez-Lopez J, Vinas M. Benefits of non-surgical periodontal treatment in patients with type 2 diabetes mellitus and chronic periodontitis: A randomized controlled trial. J Clin Periodontol. 2018 Mar;45(3):345-353. doi: 10.1111/jcpe.12858. Epub 2018 Jan 19. |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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This is a prospective clinical randomized controlled, split mouth designed, doble blinded study.
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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.
| Control |
| Drug |
saline solution 0.09% used as an adjunctive as scaling and root planing |
|
|
| Probing Depth |
mm |
| 3 months |
| clinical attachment levels | mm | 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |