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Impact of Oral Hygiene Gels on Peri-implant Mucositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03243591
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Reinhardt, University of Nebraska

Brief 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.

Condition or disease Intervention/treatment Phase
Mucositis Other: Livionex gel Other: Aquafresh gel Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, controlled, double-blind, single center
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Gels are in coded opaque tubes created at the manufacturer
Primary Purpose: Treatment
Official Title: Impact of Oral Hygiene Gels on Peri-implant Mucositis
Actual Study Start Date : August 22, 2017
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Active Comparator: Livionex gel
Brushing area of mucositis with Livionex gel for 30 days
Other: Livionex gel
Brushing area of mucositis with gel
Other Name: Aquafresh gel

Active Comparator: Aquafresh gel
Brushing area of mucositis with Aquafresh gel for 30 days
Other: Aquafresh gel
Aquafresh gel




Primary Outcome Measures :
  1. Gingival Index [ Time Frame: 30 days ]
    Level of clinical inflammation around dental implant


Secondary Outcome Measures :
  1. Plaque Index [ Time Frame: 30 days ]
    Amount of biofilm around dental implant

  2. Crevicular Fluid Biomarkers [ Time Frame: 30 days ]
    Fluid from around implant measured for inflammation markers with ELISA



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • history of 5 mm+ pocket bleeding on probing around implant

Exclusion Criteria:

  • dental treatment of implant in previous 30 days
  • Sjogrens disease
  • immunodeficiencies (e.g. AIDS)
  • poorly-controlled diabetes
  • regular use of antibiotics, anti-inflammatory drugs or immune suppressants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243591


Locations
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United States, Nebraska
University of Nebraska Medical Center College of Dentistry
Lincoln, Nebraska, United States, 68583
Sponsors and Collaborators
University of Nebraska

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Responsible Party: Richard Reinhardt, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03243591    
Other Study ID Numbers: 388-17-EP
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases