Interdental Plaque Reduction and Periodontitis
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Interdental Oral Hygiene Instruction (Int-OHI)
One session of professional supragingival scaling and polishing
Oral Hygiene Instruction (OHI)
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis
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
Sites / Locations
- University Hospital of Pisa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Control group
Test group 1
Test group 2
Test group 3
Arm Description
15 patients receiving oral hygiene instructions as determined by their group allocation (use of manual toothbrush alone)
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss)
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes)
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks)
Outcomes
Primary Outcome Measures
FMPS Full-mouth plaque score (FMPS)
Changes in FMPS, measured orally through clinical examination. Unit of measure: N
Secondary Outcome Measures
Pocket probing depth (PPD)
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Recession of the gingival margin (REC)
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Clinical attachment level (CAL)
Changes in CAL, measured orally through clinical examination. Unit of measure: mm
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)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04527913
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
August 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-centre randomized, parallel design, clinical trial with a five-week follow-up
Masking
InvestigatorOutcomes Assessor
Masking Description
Center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
15 patients receiving oral hygiene instructions as determined by their group allocation (use of manual toothbrush alone)
Arm Title
Test group 1
Arm Type
Experimental
Arm Description
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss)
Arm Title
Test group 2
Arm Type
Experimental
Arm Description
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes)
Arm Title
Test group 3
Arm Type
Experimental
Arm Description
15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks)
Intervention Type
Behavioral
Intervention Name(s)
Interdental Oral Hygiene Instruction (Int-OHI)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
One session of professional supragingival scaling and polishing
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Oral Hygiene Instruction (OHI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
FMPS Full-mouth plaque score (FMPS)
Description
Changes in FMPS, measured orally through clinical examination. Unit of measure: N
Time Frame
Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Secondary Outcome Measure Information:
Title
Pocket probing depth (PPD)
Description
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and at 5 weeks
Title
Recession of the gingival margin (REC)
Description
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and at 5 weeks
Title
Clinical attachment level (CAL)
Description
Changes in CAL, measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and at 5 weeks
Title
Gingival Index (GI)
Description
Changes in GI, measured orally through clinical examination. Unit of measure: scale from 0 (normal) to 3 (Marked redness, hypertrophy, or edema, ulceration)
Time Frame
Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Title
Angulated bleeding score (AngBS)
Description
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).
Time Frame
Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Hospital of Pisa
City
Pisa
ZIP/Postal Code
56121
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Interdental Plaque Reduction and Periodontitis
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