Impact of Oral Hygiene Gels on Peri-implant Mucositis

NCT03243591 | Completed

• 1 other identifier: 0388-17-EP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucositis

Outcome Measures

Primary Outcomes (1)

• Gingival Index

  Level of clinical inflammation around dental implant

  30 days

Secondary Outcomes (2)

• Plaque Index

  30 days

• Crevicular Fluid Biomarkers

  30 days

Study Arms (2)

Livionex gel

ACTIVE COMPARATOR

Brushing area of mucositis with Livionex gel for 30 days

Other: Livionex gel

Aquafresh gel

ACTIVE COMPARATOR

Brushing area of mucositis with Aquafresh gel for 30 days

Other: Aquafresh gel

Interventions

Livionex gel OTHER

Brushing area of mucositis with gel

Also known as: Aquafresh gel

Livionex gel

Aquafresh gel OTHER

Aquafresh gel

Aquafresh gel

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, 68583, United States

Location

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Richard A Reinhardt, DDS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Gels are in coded opaque tubes created at the manufacturer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, controlled, double-blind, single center

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 9, 2017
• Study Start: August 22, 2017
• Primary Completion: March 15, 2018
• Study Completion: July 1, 2019
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)