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To determine the efficacy of four different oral hygiene protocols involving adjunctive interdental cleaning devices in periodontal patients in terms of plaque and gingival inflammatory scores.
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD), presence of recession of the gingival margin (Rec) and full mouth plaque score (FMPS) will be recorded on six sites/tooth by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe by a calibrated examiner blind to group allocation.
Gingival index (GI) and angulated bleeding score (AngBS) will be recorded at four sites/tooth.
For GI the following scale will be used:
0 normal appearance of gingiva, no bleeding, no inflammation;
For AngBS the following scale will be used:
0: no bleeding;
Consequently, interdental plaque score (IPS), interdental gingival index (IGI), and interdental angulated bleeding score (IAngBI) will be calculated.
Patients will be followed through a five-week period. The timepoints will be the following: T -7 (oral hygiene instructions), T0 (professional supragingival scaling and polishing), T14, T28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental | 15 patients receiving oral hygiene instructions as determined by their group allocation (use of manual toothbrush alone) |
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| Test group 1 | Experimental | 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss) |
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| Test group 2 | Experimental | 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes) |
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| Test group 3 | Experimental | 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interdental Oral Hygiene Instruction (Int-OHI) | Behavioral | Int-OHI will be given focusing on the interdental device of the allocated group for each patient and will be given only once at timepoint T-7. No further formal Int-OH instructions will be given, unless specifically asked by the patient. Int-OHI will be delivered by trained dental hygienist/periodontist. |
| Measure | Description | Time Frame |
|---|---|---|
| FMPS Full-mouth plaque score (FMPS) | Changes in FMPS, measured orally through clinical examination. Unit of measure: N | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket probing depth (PPD) | Changes in PPD, measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and at 5 weeks |
| Recession of the gingival margin (REC) | Changes in REC, measured orally through clinical examination. Unit of measure: mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Pisa | Pisa | 56121 | Italy |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Single-centre randomized, parallel design, clinical trial with a five-week follow-up
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Center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
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| One session of professional supragingival scaling and polishing | Procedure | A session of professional supragingival scaling and polishing: instrumentation will be performed by a trained dental hygienist/periodontist with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed. |
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| Oral Hygiene Instruction (OHI) | Procedure | OHI will be given focusing on manual toothbrushing and will be given only once at timepoint T-7. No further formal OH instructions will be given, unless specifically asked by the patient. OHI will be delivered by trained dental hygienist/periodontist. |
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| Measured at Baseline and at 5 weeks |
| Clinical attachment level (CAL) | Changes in CAL, measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and at 5 weeks |
| Gingival Index (GI) | Changes in GI, measured orally through clinical examination. Unit of measure: scale from 0 (normal) to 3 (Marked redness, hypertrophy, or edema, ulceration) | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks |
| Angulated bleeding score (AngBS) | Changes in AngBS, measured orally through clinical examination. Unit of measure: scale from 0 (no bleeding), 1 (bleeding upon probe stimulation) to 2 (spontaneous bleeding). | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks |