Interdental Plaque Reduction and Periodontitis

Not Applicable

Completed

• Conditions: Periodontitis

• Registration Number: NCT04527913
• Lead Sponsor: University of Pisa

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2019-06
• Study Completion: 2020-08
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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).

Trial Locations

Locations (1)

University Hospital of Pisa; 🇮🇹 Pisa, Italy