Impact of Oral Hygiene Gels on Peri-implant Mucositis
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|ClinicalTrials.gov Identifier: NCT03243591|
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mucositis||Other: Livionex gel Other: Aquafresh gel||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||21 participants|
|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|
|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|
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
- Gingival Index [ Time Frame: 30 days ]Level of clinical inflammation around dental implant
- Plaque Index [ Time Frame: 30 days ]Amount of biofilm around dental implant
- Crevicular Fluid Biomarkers [ Time Frame: 30 days ]Fluid from around implant measured for inflammation markers with ELISA
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
|United States, Nebraska|
|University of Nebraska Medical Center College of Dentistry|
|Lincoln, Nebraska, United States, 68583|