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Completed

NCT Number: NCT04527913

Interdental Plaque Reduction and Periodontitis

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Pisa

Pisa, 56121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. FMPS Full-mouth plaque score (FMPS)

    Time frame: 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 outcomes

  1. Pocket probing depth (PPD)

    Time frame: 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)

    Time frame: Measured at Baseline and at 5 weeks

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

  3. Clinical attachment level (CAL)

    Time frame: Measured at Baseline and at 5 weeks

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

  4. Gingival Index (GI)

    Time frame: 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)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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