An interventional study of Power sonic toothbrush and Manual toothbrush in Plaque Induced Gingivitis, sponsored by Lander Enterprises, LLC. Completed at 1 site in United States. Open to participants aged 5 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Lander Enterprises, LLC · Not applicable, Interventional, and Treatment
The goal of this 30 day, randomized, two group, parallel, examiner-blind clinical study is to evaluate the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on supragingival dental plaque and gingivitis, compared to an American Dental Association (ADA) reference manual soft toothbrush. The extent of gingival abrasion and recession and oral safety will be evaluated.
This single-center, randomized, controlled, examiner-blind, 30-day parallel designs study will consist of Screening and Baseline visits with approximately 80 subjects (age 5-65 years) who will read and sign an informed consent form and assent form, be assessed for evidence of gingivitis and plaque according to the Modified Gingival Index (MGI) and the Lobene-Soparkar Modification of Turesky Modified Quigley-Hein Plaque Index (LSPI) at Baseline, and days 15 and 30 post-baseline. Oral safety, gingival recession and gingival abrasion will be measured at all visits. Subjects will be randomly assigned to one of two groups: twice daily brushing with a fluoride toothpaste and 1) two-minute brushing with ADA reference standard manual toothbrush, or 2) 30-second brushing with AutoBrush® 360° U-shaped Sonic Toothbrush.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 76 is above the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Lander Enterprises, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: U-shaped Power Toothbrush with fluoride toothpaste
Device: Power sonic toothbrush
Device: Soft Manual Toothbrush with fluoride toothpaste
Device: Manual toothbrush
Subjects will brush twice daily for 30 seconds using a fluoride toothpaste.
Also known as: AutoBrush 360 U-Shaped power toothbrush
Subjects will brush twice daily for 2 minutes using a fluoride toothpaste.
Also known as: ADA Reference standard soft manual toothbrush
Gingivitis: Modified Gingival Index (MGI)
Gingival Inflammation, assessed on a 5-point scale (0 to 4), will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of all scorable teeth using criteria: 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 = Mild inflammation of the entire gingival unit; 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Time frame: Whole mouth mean change in MGI scores at Day 30.
Plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index (LSPI)
Plaque will be disclosed using a red disclosing solution and each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual), according to the criteria noted below: 0 = No plaque; 1 = Separate flecks or discontinuous band of plaque at the gingival (cervical) margin; 2 = Thin (up to 1 mm), continuous band of plaque at the gingival margin; 3 = Band of plaque wider than 1 mm but less than 1/3 of tooth surface area; 4 = Plaque covering 1/3 or more, but less than 2/3 of tooth surface area; 5 = Plaque covering 2/3 or more of tooth surface area.
Time frame: Whole mouth mean change in LSPI scores at Day 30, immediate post-brushing (Pre- to Post-Brushing scores)
Gingivitis
Whole mouth MGI, Gumline MGI, Proximal, Mean distal score of the last posterior tooth in each quadrant.
Time frame: Change from Baseline at Day 15 and Day 30]
Plaque
LSPI: Whole mouth, Gumline, Proximal, distal score of the last posterior tooth in each quadrant.
Time frame: Change from Baseline at Day 15 and Day 30
Safety: gingival recession
Gingival recession measurements (mm) will be carried out at six sites per tooth (mesio-buccal, mid-buccal, distobuccal, mesio-lingual, mid-lingual, and disto-lingual). Recession will be measured as the visible distance from the cemento-enamel junction (CEJ) to the gingival margin.
Time frame: Changes from Baseline at Day 15 and Day 30
Safety: gingival abrasion
Gingival Abrasion will be assessed with a 2-tone disclosing solution to help visualize abraded areas of the oral epithelium. Gingival tissues of each tooth will be divided into 3 areas on both the facial and lingual surfaces, as illustrated in Fig. 1: marginal (cervical free gingiva), interdental (papillary free gingiva) and mid-gingival (attached gingiva). If abrasion is present, the site will be recorded as small (≤2 mm), medium (3-5 mm) and large (\>5 mm). If no abrasion is present, the site will be recorded as "0".
Time frame: Changes from Baseline at Day 15 and Day 30
Plan to share: No
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Lander Enterprises, LLC