Periodontitis
Conditions
Brief summary
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.
Detailed description
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; 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.
Interventions
BEHAVIORALInterdental 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.
PROCEDUREOne 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.
PROCEDUREOral 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.
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
Intervention model description
Single-centre randomized, parallel design, clinical trial with a five-week follow-up
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* males or females of age range between 18 and 70 years, * 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
* pregnancy or breast-feeding, * indication to antibiotic therapy prior to treatment, * chronic infections, * systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases), * not willing to give a consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FMPS Full-mouth plaque score (FMPS) | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks | Changes in FMPS, measured orally through clinical examination. Unit of measure: N |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pocket probing depth (PPD) | Measured at Baseline and at 5 weeks | Changes in PPD, measured orally through clinical examination. Unit of measure: mm |
| Recession of the gingival margin (REC) | Measured at Baseline and at 5 weeks | Changes in REC, measured orally through clinical examination. Unit of measure: mm |
| Clinical attachment level (CAL) | Measured at Baseline and at 5 weeks | Changes in CAL, measured orally through clinical examination. Unit of measure: mm |
| Gingival Index (GI) | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks | Changes in GI, measured orally through clinical examination. Unit of measure: scale from 0 (normal) to 3 (Marked redness, hypertrophy, or edema, ulceration) |
| Angulated bleeding score (AngBS) | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks | 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). |
Countries
Italy
Outcome results
None listed