RECRUITING

Novel Dental Gel as an Adjunct to Scaling and Root Planing

Conditions

Periodontal Diseases Gingival Diseases Gingival Pocket Gum Bleed Plaque, Dental

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the use of Livionex Dental Gel (LDG) as a home care product in reducing probing pocket depth (PD) beyond the effect achieved by the current standard of care with SRP in periodontitis patients.

Official Title

Randomized Control Trial of a Novel Dental Gel as an Adjunct to Scaling and Root Planing in Subjects With Stage II and III Periodontitis

Quick Facts

Study Start:2022-10-14

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05384132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female subjects at least 18 years of age. * Subject must be willing and able to provide written informed consent. * Available during the course of the study. * Must have minimum of 20 natural teeth, excluding third molars. * Must have at least 20 BOP sites, excluding third molars. * Stage II or III, Grade B periodontitis with at least 4 teeth with a minimum PD of 5 mm and minimum CAL of 3mm. * No antibiotic therapy for periodontal disease or chronic use of anti-inflammatory drugs (NSAIDs) within the past month of Baseline, or during the study. * Must not have received definitive treatment (i.e., SRP or periodontal surgical therapy) for periodontitis in the last one year. * Subject must be willing and able to comply with study visits as described in the protocol. * Subjects must be available for follow up on the telephone. * Able to read and understand the consent form in English	* • Pregnancy or breast feeding. * Medical condition that requires pre-medication prior to dental procedures. * Systemic conditions and use of medications that may affect periodontal tissues. * Severe dental disease characterized multiple decayed, untreated dental sites. * Presence of orthodontic appliances. * Diseases of oral soft or hard tissues. * Participating in another clinical trial currently or in the month preceding this study. * Stage IV and/or Grade C periodontitis. * Vertical bone defects 4mm or greater. * Subjects who have active dental infections other than periodontitis that will require dental treatment during the study period. * Excessive oral hygiene practices including use of water irrigation devices such as Waterpik or use of interdental cleansers more than twice daily. * Non-English speaking * Smokers, uncontrolled or brittle diabetics, HIV/AIDS, and subjects with severe systemic disease, e.g., cancer, lupus, pemphigus vulgaris/pemphigoid, or other oral mucous membrane diseases that would interfere with performance of oral hygiene, e.g., erosive lichen planus, recurrent major aphthous lesions, etc. * History of allergic reaction to any ingredient in the test/control dentifrices. * Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the subject's ability to comply with study requirements, including completion of the study or the quality of the data. * Subjects unwilling to use manual toothbrush during the study.

Inclusion Criteria

Exclusion Criteria

* Male or female subjects at least 18 years of age.
* Subject must be willing and able to provide written informed consent.
* Available during the course of the study.
* Must have minimum of 20 natural teeth, excluding third molars.
* Must have at least 20 BOP sites, excluding third molars.
* Stage II or III, Grade B periodontitis with at least 4 teeth with a minimum PD of 5 mm and minimum CAL of 3mm.
* No antibiotic therapy for periodontal disease or chronic use of anti-inflammatory drugs (NSAIDs) within the past month of Baseline, or during the study.
* Must not have received definitive treatment (i.e., SRP or periodontal surgical therapy) for periodontitis in the last one year.
* Subject must be willing and able to comply with study visits as described in the protocol.
* Subjects must be available for follow up on the telephone.
* Able to read and understand the consent form in English

* • Pregnancy or breast feeding.
* Medical condition that requires pre-medication prior to dental procedures.
* Systemic conditions and use of medications that may affect periodontal tissues.
* Severe dental disease characterized multiple decayed, untreated dental sites.
* Presence of orthodontic appliances.
* Diseases of oral soft or hard tissues.
* Participating in another clinical trial currently or in the month preceding this study.
* Stage IV and/or Grade C periodontitis.
* Vertical bone defects 4mm or greater.
* Subjects who have active dental infections other than periodontitis that will require dental treatment during the study period.
* Excessive oral hygiene practices including use of water irrigation devices such as Waterpik or use of interdental cleansers more than twice daily.
* Non-English speaking
* Smokers, uncontrolled or brittle diabetics, HIV/AIDS, and subjects with severe systemic disease, e.g., cancer, lupus, pemphigus vulgaris/pemphigoid, or other oral mucous membrane diseases that would interfere with performance of oral hygiene, e.g., erosive lichen planus, recurrent major aphthous lesions, etc.
* History of allergic reaction to any ingredient in the test/control dentifrices.
* Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the subject's ability to comply with study requirements, including completion of the study or the quality of the data.
* Subjects unwilling to use manual toothbrush during the study.

Contacts and Locations

Study Contact

Maninder Kaur, BDS,MPH,MS

CONTACT

2059344506

maninder@uab.edu

Sarah Startley, DMD

CONTACT

2059758711

ss1971@uab.edu

Study Locations (Sites)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-14

Study Completion Date2026-10

Study Record Updates

Study Start Date2022-10-14

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Periodontal Diseases
Gingival Diseases
Gingival Pocket
Gum Bleed
Plaque, Dental