NCT04527913

Interdental Plaque Reduction and Periodontitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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; 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.

Conditions

• Periodontitis

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2019-06-01
• Completion: 2020-08-01
• First posted: 2020-08-27
• Last updated: 2022-11-07

Locations

1 site across 1 country: Italy