Impact of Oral Hygiene Gels on Peri-implant Mucositis

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.

Study Overview

• Status: Completed
• Conditions: Mucositis
• Intervention / Treatment: Other: Livionex gel; Other: Aquafresh gel

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68583
      • University of Nebraska Medical Center, College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Aquafresh gel
Active Comparator: Aquafresh gel; Brushing area of mucositis with Aquafresh gel for 30 days	Other: Aquafresh gel; Aquafresh gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Index	Level of clinical inflammation around dental implant	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	Amount of biofilm around dental implant	30 days
Crevicular Fluid Biomarkers	Fluid from around implant measured for inflammation markers with ELISA	30 days

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Richard A Reinhardt, DDS, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: 0388-17-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No