Interdental Plaque Reduction and Periodontitis

NCT04527913 | Completed

• 1 other identifier: Periobrush
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pocket probing depth (PPD)

  Measured at Baseline and at 5 weeks

• Recession of the gingival margin (REC)

  Measured at Baseline and at 5 weeks

• Clinical attachment level (CAL)

  Measured at Baseline and at 5 weeks

• Gingival Index (GI)

  Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks

• Angulated bleeding score (AngBS)

  Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks

Study Arms (4)

Control group

EXPERIMENTAL

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; Procedure: Oral Hygiene Instruction (OHI)

Test group 1

EXPERIMENTAL

15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss)

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

Test group 2

EXPERIMENTAL

15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes)

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

Test group 3

EXPERIMENTAL

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); Procedure: One session of professional supragingival scaling and polishing; Procedure: Oral Hygiene Instruction (OHI)

Interventions

Interdental Oral Hygiene Instruction (Int-OHI) BEHAVIORAL

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.

Test group 1; Test group 2; Test group 3

One session of professional supragingival scaling and polishing PROCEDURE

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.

Control group; Test group 1; Test group 2; Test group 3

Oral Hygiene Instruction (OHI) PROCEDURE

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.

Control group; Test group 1; Test group 2; Test group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University Hospital of Pisa

Pisa, 56121, Italy

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Single-centre randomized, parallel design, clinical trial with a five-week follow-up

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 27, 2020
• Study Start: September 1, 2011
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2020
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

IT (1)