Interdental Plaque Reduction and Periodontitis

University of Pisa

Status: Completed

Conditions: Periodontitis

Treatments: Procedure: Oral Hygiene Instruction (OHI); Behavioral: Interdental Oral Hygiene Instruction (Int-OHI); Procedure: One session of professional supragingival scaling and polishing

Study type: Interventional

Funder types: Other

Identifiers

NCT04527913

Periobrush

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Control group

Experimental group

Description:

15 patients receiving oral hygiene instructions as determined by their group allocation (use of manual toothbrush alone)

Treatment:

Procedure: Oral Hygiene Instruction (OHI)

Procedure: One session of professional supragingival scaling and polishing

Test group 1

Experimental group

Description:

15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss)

Treatment:

Procedure: Oral Hygiene Instruction (OHI)

Behavioral: Interdental Oral Hygiene Instruction (Int-OHI)

Procedure: One session of professional supragingival scaling and polishing

Test group 2

Experimental group

Description:

15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes)

Treatment:

Procedure: Oral Hygiene Instruction (OHI)

Behavioral: Interdental Oral Hygiene Instruction (Int-OHI)

Procedure: One session of professional supragingival scaling and polishing

Test group 3

Experimental group

Description:

15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks)

Treatment:

Procedure: Oral Hygiene Instruction (OHI)

Behavioral: Interdental Oral Hygiene Instruction (Int-OHI)

Procedure: One session of professional supragingival scaling and polishing