Adults 18 to 70, any sex, with Plaque, Dental or Gingivitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change of Navy Plaque Index (Navy Pl) After One-time BrushingPrimary· Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. Post-brushing value is calculated by averaging PI values of 10 subjects after
Baseline
Group
Value
95% CI
Tapered Bristles A
367.5
± 67.4
Tapered Bristles B
346.5
± 70.4
End Rounded Bristles
355
± 50.9
After one-time brushing for 2 minutes
Group
Value
95% CI
Tapered Bristles A
145.4
± 61.8
Tapered Bristles B
123.8
± 59.6
End Rounded Bristles
130.1
± 59.0
Change of Navy Plaque Index (Navy PI) After 7-day BrushingSecondary· Pre-intervention at baseline and after 7- day brushing at baseline
Change of Navy Plaque Index (Navy Pl) after 7-day brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. 7-day value is calculated by averaging PI values of 10 subjects after 7-day brush
Baseline
Group
Value
95% CI
Tapered Bristles A
366.3
± 67.6
Tapered Bristles B
346.9
± 70.4
End Rounded Bristles
354.9
± 51.2
7 days
Group
Value
95% CI
Tapered Bristles A
372.3
± 42.1
Tapered Bristles B
373.8
± 49.8
End Rounded Bristles
380.1
± 44.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 1 week.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods.
This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT06017817 — Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
· NA
· recruiting
NCT06453005 — Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial
· NA
· recruiting
NCT05965076 — Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patie
· NA
· recruiting
NCT05384132 — Novel Dental Gel as an Adjunct to Scaling and Root Planing
· NA
· recruiting
Other Sunstar Americas trials
Trials by the same sponsor.
NCT04289051 — Clinical Evaluation of Oral Rinse for Xerostomia
· NA
· completed
NCT03213210 — Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis
· NA
· terminated
NCT03215667 — Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites
· NA
· terminated
NCT02702609 — Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sunstar Americas
Last refreshed: 15 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04681885.