Interdental Plaque Reduction and Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: One session of professional supragingival scaling and polishing; Procedure: Oral Hygiene Instruction (OHI); Behavioral: Interdental Oral Hygiene Instruction (Int-OHI)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56121
    • University Hospital of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; 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; 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.; Procedure: Oral 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.
Experimental: Test group 1; 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss)	Procedure: One 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.; Procedure: Oral 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.; Behavioral: Interdental 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.
Experimental: Test group 2; 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes)	Procedure: One 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.; Procedure: Oral 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.; Behavioral: Interdental 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.
Experimental: Test group 3; 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks)	Procedure: One 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.; Procedure: Oral 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.; Behavioral: Interdental 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: Periobrush

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No