Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2011-09-30
2020-08-31
Brief Summary
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Detailed Description
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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;
1. slight change and moderate edema with slight change in texture, no bleeding, mild inflammation;
2. redness hypertrophy, or edema and glazing, bleeding on probing, moderate inflammation;
3. marked redness, hypertrophy, or edema, ulceration, spontaneous bleeding, severe inflammation.
For AngBS the following scale will be used:
0: no bleeding;
1. bleeding upon probe stimulation;
2. spontaneous 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control group
15 patients receiving oral hygiene instructions as determined by their group allocation (use of manual toothbrush alone)
One session of professional supragingival scaling and polishing
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.
Oral Hygiene Instruction (OHI)
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.
Test group 1
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss)
Interdental Oral Hygiene Instruction (Int-OHI)
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.
One session of professional supragingival scaling and polishing
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.
Oral Hygiene Instruction (OHI)
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.
Test group 2
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes)
Interdental Oral Hygiene Instruction (Int-OHI)
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.
One session of professional supragingival scaling and polishing
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.
Oral Hygiene Instruction (OHI)
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.
Test group 3
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks)
Interdental Oral Hygiene Instruction (Int-OHI)
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.
One session of professional supragingival scaling and polishing
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.
Oral Hygiene Instruction (OHI)
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.
Interventions
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Interdental Oral Hygiene Instruction (Int-OHI)
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.
One session of professional supragingival scaling and polishing
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.
Oral Hygiene Instruction (OHI)
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.
Eligibility Criteria
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Inclusion Criteria
* good health status,
* presence of at least 20 natural teeth
* residual periodontal pockets with PPD≥4mm, in need of specific oral hygiene regimen.
Exclusion Criteria
* indication to antibiotic therapy prior to treatment,
* chronic infections,
* systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
* not willing to give a consent
18 Years
70 Years
ALL
Yes
Sponsors
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University of Pisa
OTHER
Responsible Party
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Filippo Graziani, DDS MClinDent PhD
Full Professor
Locations
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University Hospital of Pisa
Pisa, , Italy
Countries
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Other Identifiers
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Periobrush
Identifier Type: -
Identifier Source: org_study_id
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