Interdental Plaque Reduction and Periodontitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527913
• Other study ID #: Periobrush
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: August 2020

Study information

• Verified date: November 2022
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
Italy	University Hospital of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pocket probing depth (PPD)	Changes in PPD, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and at 5 weeks
Secondary	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
Secondary	Clinical attachment level (CAL)	Changes in CAL, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and at 5 weeks
Secondary	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
Secondary	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