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Professional oral hygiene has become a customary procedure in everyday dentistry. Both manual and sonic brushes are part of normal oral hygiene education practice. Compared with manual toothbrushes, ergonomic instruments, such as sonic toothbrushes, can be a more practical and less demanding mean to remove biofilm and plaque efficiently. Studies in literature investigate the efficacy of toothbrushes in plaque removal, but the investiagator's study would validate efficacy of toothbrushes post-causal therapy, towards lower plaque accumulation, and reduction in bleeding.
The objective of this study is to compare two methods (manual VS sonic) of tooth brushing in terms of impact on the gingival index and plaque index after one session of Full Mouth-Erythritol Powder Air Polishing Therapy (FM-EPAPT) in healthy patients.
The hypothesis of the present randomized controlled trial is that sonic tooth brushing accumulates less plaque (-10%) than manual tooth brushing.
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be instructed to use:
Everyone's goal to have a healthy mouth is the removal of biofilm, plaque and calculus from the dental surface everyday. Moreover routine recalls ensure a better oral health and greater protection against caries, gingivitis and periodontitis. Regular attendance to oral hygiene sessions plays an important role but has to be accompanied by the compliance with home oral care instructions. The patients should be adequately instructed to take care of their oral health.
TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.
STUDY POPULATION: Healthy subject affected by gingivitis are included in the study. Presence of gingivitis is defined as bleeding on probing (BOP) > 25%.
PRIMARY OUTCOME: Change in Plaque Index (PI): change in 10% less of the site in test group.
SECONDARY OUTCOME:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonic toothbrush | Experimental |
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| Manual toothbrush | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonic Toothbrush | Device | Sonic Toothbrush (Philips Sonicare Flexcare Platinum ToothbrushĀ®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plaque Index (PI) | Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits. Change in 10% of the site in test group. 10% site modification in favor of the test group. | Baseline, 2, 4, 6 weeks and 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gingival Index (GI) | Change in percentage of site with bleeding after gently run on the surface of the marginal gingiva. Baseline values will be compared to the values recorded in the follow-up visits. | Baseline, 2, 4, 6 weeks and 6, 12 months |
| Change in REC (Clinical Gingival Recession) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magda Mensi | Asst Degli Spedali Civili Di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magda Mensi | Brescia | Lombardy | 25123 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2017 | Sep 16, 2020 |
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Monocetric, pragmatic, single blinded, randomized clinical trial, parallel design.
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| Manual Toothbrush | Device | Manual brushing (Technique Pro - GUMĀ® Sunstar Italiana SRL) |
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Change in mean of REC value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits. |
| Baseline 6, 12 months |
| Change in CAL (Clinical Attachment Level) | Change in mean of CAL value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits. | Baseline 6, 12 months |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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