Exploratory Study of Iocide Oral Rinse in a Diabetic Population

NCT00801164 | Completed Phase 1

• 1 other identifier: HSC20080508H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control and biomarkers of systemic inflammation.

Conditions

Diabetes Type 2; Periodontitis

Keywords

Diabetes Type 2; Periodontitis

Outcome Measures

Primary Outcomes (1)

• The primary study endpoints are periodontal evaluation including clinical attachment level, pocket depth, plaque index, suppuration and gingival index score.

  6 Months

Secondary Outcomes (1)

• Secondary endpoints include glycated hemoglobin A1c (HbA1c) and systemic biomarkers (LPS, TNF-a, CRP, IL-6, serum insulin and glucose). Tertiary outcome measures include staining, calculus, opportunistic Candida infection, and patient satisfaction.

  6 Months

Study Arms (2)

Frio Oral Rinse

EXPERIMENTAL

Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.

Drug: Frio Mouth Rinse

Placebo

EXPERIMENTAL

Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.

Drug: Frio Mouth Rinse Placebo

Interventions

Frio Mouth Rinse Placebo DRUG

Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.

Placebo

Frio Mouth Rinse DRUG

Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.

Frio Oral Rinse

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have self-reported type 2 diabetes of more than three months duration.
• A current HbA1c value between 7.0% and 12%.
• Report no change in diabetes-related medications during the three months prior to enrollment.
• Be at least 35 years of age.
• Have at least 16 natural teeth.
• Have moderate to severe chronic periodontitis, defined by loss of clinical attachment of \>5 mm on two seperate teeth, and no treatment within six months.
• Able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol
• Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures
• Females with childbearing potential must have a negative pregnancy test before and during the study period. Sexually active females must be using an effective form of birth control. These methods include oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant®), medroxyprogesterone acetate injections (Depo-provera®) or contraceptive foam with a condom.

You may not qualify if:

• History, or current evidence, of any significant acute or chronic medical or psychiatric condition that, in the opinion of the Investigator, would render examination difficult or invalid or prevent the subject from active study participation
• TPOab positive
• Baseline serum level of TSH \<0.35 or \>5.5
• Treatment with antibiotic within the three (3) month period prior to the screening examination
• Presence of valvular disease, prosthetic implant, or any other systemic condition requiring antibiotic premedication
• History of thyroid disease
• Purported sensitivity or allergy to iodine
• Known sensitivity or allergy to shellfish
• History of autoimmune disease, or chronic infections such as HIV or hepatitis
• History of cardiovascular disease (heart attack or procedure within the past three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months), unstable angina pectoris or angina pectoris at rest,
• History of renal disease: serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis.
• Gross oral pathology (periodontal disease, rampant caries, tissue damage created by poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the Investigator, could alter the treatment needs during the study
• Current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores
• Presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed
• History of or current alcohol abuse that, in the opinion of the Investigator, could influence the outcome of the study

Sponsors & Collaborators

• Biomedical Development Corporation: lead
• Methodist Healthcare Ministries of South Texas: collaborator
• Foundation Of Collaborative Unique Science (FOCUS): collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio, Dental School

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontitis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Thomas W. Oates, DMD, Ph.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

US (1)