Clinical trial NCT04527913: Interdental Plaque Reduction and Periodontitis
Official title: Interdental Plaque Reduction After Use of Different Devices in Patients With Periodontitis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre randomized, parallel design, clinical trial with a five-week follow-up
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: FMPS Full-mouth plaque score (FMPS)
timeFrame: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Secondary outcomes:
measure: Pocket probing depth (PPD)
timeFrame: Measured at Baseline and at 5 weeks
measure: Recession of the gingival margin (REC)
timeFrame: Measured at Baseline and at 5 weeks
measure: Clinical attachment level (CAL)
timeFrame: Measured at Baseline and at 5 weeks
measure: Gingival Index (GI)
timeFrame: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
measure: Angulated bleeding score (AngBS)
timeFrame: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University Hospital of Pisa
Study officials:
References: