Interdental Plaque Reduction and Periodontitis

• Sponsor: University of Pisa (Other)
• Overall Status: Completed
• CT.gov ID: NCT04527913
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4
• Actual Duration (Months): 107
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Behavioral: Interdental Oral Hygiene Instruction (Int-OHI); Procedure: One session of professional supragingival scaling and polishing; Procedure: Oral Hygiene Instruction (OHI)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-centre randomized, parallel design, clinical trial with a five-week follow-upSingle-centre randomized, parallel design, clinical trial with a five-week follow-up
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
• Primary Purpose: Prevention
• Official Title: Interdental Plaque Reduction After Use of Different Devices in Patients With Periodontitis: a Randomized Clinical Trial
• Actual Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

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 T0. 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)	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 T0. 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.; 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 T0. 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 2 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes)	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 T0. 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.; 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 T0. 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 3 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); 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 T0. 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.; 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 T0. No further formal OH instructions will be given, unless specifically asked by the patient. OHI will be delivered by trained dental hygienist/periodontist.

Outcome Measures

Primary Outcome Measures

1. 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

1. Pocket probing depth (PPD) [Measured at Baseline and at 5 weeks]

   Changes in PPD, measured orally through clinical examination. Unit of measure: mm

2. 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

3. Clinical attachment level (CAL) [Measured at Baseline and at 5 weeks]

   Changes in CAL, measured orally through clinical examination. Unit of measure: mm

4. 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)

5. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Pisa	Pisa		Italy	56121

Sponsors and Collaborators

• University of Pisa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Filippo Graziani, DDS MClinDent PhD, Full Professor, University of Pisa
• ClinicalTrials.gov Identifier: NCT04527913
• Other Study ID Numbers: Periobrush
• First Posted: Aug 27, 2020
• Last Update Posted: Aug 28, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis

Study Results

No Results Posted as of Aug 28, 2020