Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03243591 |
| Other study ID # |
0388-17-EP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2017 |
| Est. completion date |
July 1, 2019 |
Study information
| Verified date |
September 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing
the risk of loss of bone support. The purpose of this study is to evaluate the impact of
brushing the bacterial biofilm at the implant-mucosa interface with one of two,
commercially-available dental gels over a 30-day period on amounts of biofilm and indices of
mucosal inflammation. Adult subjects (> 19 years old) will be invited to consent if they have
at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater,
no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens
disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic
antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel
group will be instructed to apply a pea size amount of dentifrice brushing the implant and
mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to
record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and
adverse events.
Description:
This will be a prospective, randomized, controlled, double-blind, single center study. Once
eligibility has been determined, up to 21 Subjects will be enrolled. Subjects will be
randomly assigned in a 1:1 ratio to treat with either Livionex Dental Gel (a plaque control
gel that is safe for ingestion and is currently sold by Livionex Inc.) or the control
Aquafresh toothpaste. Each study visit will last 30 minutes.
The soft tissue around the dental implant will be observed at baseline and after 30 days for
inflammation using the Gingivitis Index and probed with a UNC 15 periodontol probe for pocket
depth and bleeding. A photograph will be taken of the most inflamed side of the implant.
Plaque will be stained with oral hygiene staining rinse and evaluated for Plaque Index.
Finally, a paper strip will be inserted between the gingiva and implant on facial and lingual
sides for 30 seconds each.
GINGIVITIS INDEX: Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation, 1 =
Mild inflammation slight change in color and little change in texture 2 = Moderate
inflammation moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon
probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous
bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around
the tooth) scored.
PLAQUE INDEX Using Quigley Staining Hein Method with Turesky Modification:Units on a scale 0
to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band
of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two
thirds of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque
score = sum of all scores divided by the number of sites (teeth) scored.
Each patients will be instructed to brush around the implant with a pea size amount of
dentifrice provided, twice daily for 30 days.
