Interdental Plaque Reduction and Periodontitis

Study Overview
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Brief Summary
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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
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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; slight change and moderate edema with slight change in texture, no bleeding, mild inflammation; redness hypertrophy, or edema and glazing, bleeding on probing, moderate inflammation; marked redness, hypertrophy, or edema, ulceration, spontaneous bleeding, severe inflammation. For AngBS the following scale will be used: 0: no bleeding; bleeding upon probe stimulation; 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.

Official Title
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Interdental Plaque Reduction After Use of Different Devices in Patients With Periodontitis: a Randomized Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Behavioral: Interdental Oral Hygiene Instruction (Int-OHI)
* Procedure: One session of professional supragingival scaling and polishing
* Procedure: Oral Hygiene Instruction (OHI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-centre randomized, parallel design, clinical trial with a five-week follow-up
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>15 patients receiving oral hygiene instructions as determined by their group allocation (use of manual toothbrush alone) | Procedure: One session of professional supragingival scaling and polishing<br>* 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.<br>Procedure: Oral Hygiene Instruction (OHI)<br>* 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.<br>|
| Experimental: Test group 1<br>15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss) | Behavioral: Interdental Oral Hygiene Instruction (Int-OHI)<br>* 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.<br>Procedure: One session of professional supragingival scaling and polishing<br>* 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.<br>Procedure: Oral Hygiene Instruction (OHI)<br>* 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.<br>|
| Experimental: Test group 2<br>15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes) | Behavioral: Interdental Oral Hygiene Instruction (Int-OHI)<br>* 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.<br>Procedure: One session of professional supragingival scaling and polishing<br>* 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.<br>Procedure: Oral Hygiene Instruction (OHI)<br>* 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.<br>|
| Experimental: Test group 3<br>15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks) | Behavioral: Interdental Oral Hygiene Instruction (Int-OHI)<br>* 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.<br>Procedure: One session of professional supragingival scaling and polishing<br>* 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.<br>Procedure: Oral Hygiene Instruction (OHI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FMPS Full-mouth plaque score (FMPS) | Changes in FMPS, measured orally through clinical examination. Unit of measure: N | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket probing depth (PPD) | Changes in PPD, measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and at 5 weeks | 
| Recession of the gingival margin (REC) | Changes in REC, measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and at 5 weeks | 
| Clinical attachment level (CAL) | Changes in CAL, measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and at 5 weeks | 
| Gingival Index (GI) | Changes in GI, measured orally through clinical examination. Unit of measure: scale from 0 (normal) to 3 (Marked redness, hypertrophy, or edema, ulceration) | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks | 
| Angulated bleeding score (AngBS) | 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). | Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks |