Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diamine Silver Fluoride and Potassium Iodide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02771704
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Maribasappa Karched, Kuwait University

Brief Summary:
Dental caries is an infectious disease mediated by a consortium of microbes in the oral cavity. The disease is characterized by demineralization of the tooth, if untreated, it leads to cavitation, discomfort, pain and eventual tooth loss. Frequently, complete caries removal of dentine carious lesions leads to exposure of the pulp affecting its vitality. Therefore, it is crucial that vitality of the teeth is preserved causing little damage to the pulp. Different approaches have been used to reduce or eliminate microorganisms underneath the restorations. Chlorhexidine has a strong antibacterial effect, particularly on planktonic bacteria. Its effect on bacterial biofilms is compromised, however The objective of this study is to examine the in vivo effect of diamine silver fluoride, potassium iodide and their mixture on bacteria present in deep carious lesions. Dentine samples from 5 carious lesions from each of 5 patients before and after treatment with test agents will be collected in pre-reduced sterile Ringer's solution and processed for microbiological evaluation. The samples after serial dilution and plating will be incubated in aerobic, anaerobic and CO2 atmosphere for 2-5 days. Colony forming units will be enumerated and the effect of antibacterial agents in question on the bacterial viability in carious lesions will be assessed.

Condition or disease Intervention/treatment Phase
Dentine Caries Other: Silver Diamine fluoride Other: Potassium iodide Other: Chlorhexidine Other: Silver diamine fluoride and potassium iodide Other: Physiological saline Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Vivo Evaluation of the Antimicrobial Activity of Diamine Silver Fluoride and Potassium Iodide on Dentin Carious Lesions in Kuwaiti Subjects.
Study Start Date : October 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Silver diamine fluoride
Intervention: Silver diamine fluoride will be applied in vivo on carious dentine lesions
Other: Silver Diamine fluoride
Experimental: Potassium iodide
Potassium iodide will be applied in vivo on carious dentine lesions.
Other: Potassium iodide
Experimental: Chlorhexidine
Chlorhexidine will be applied in vivo on carious dentine lesions
Other: Chlorhexidine
Experimental: Silver diamine fluoride+Potassium iodide
Silver diamine fluoride and potassium iodide mixture will be applied in vivo on carious dentine lesions
Other: Silver diamine fluoride and potassium iodide
Experimental: Saline
Sterile physiological saline will be applied in vivo on carious dentine lesions
Other: Physiological saline



Primary Outcome Measures :
  1. antibacterial activity measured by total viable counts after treatment [ Time Frame: Through study completion, an average of 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient should be able to give informed consent.
  • had at least 5 teeth with moderate size caries lesions (for 5 treatments), to be exact with the lesion size.
  • the carious lesion should at least penetrate to the inner ½ of dentine thickness.
  • the lesion should be suitable for the placement of a Vitrabond lining of 0.5-1.0 mm
  • permanent restoration should be a part of a current and approved treatment plan

Exclusion Criteria:

  • Inability of the patient to give informed consent.
  • teeth had received temporary restoration
  • isolation with rubber dam is not possible.
  • if cavity preparation was contaminated due to gingival bleeding

All patients were placed under a follow up system for the purpose of addressing any complaints that might result from the sampling procedure.


Information from the National Library of Medicine

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): NCT02771704


Sponsors and Collaborators
Kuwait University
Investigators
Layout table for investigator information
Principal Investigator: Maribasappa Karched, PhD Kuwait University

Publications:
Jouseimies-Somer H, Summanen P, Citron DM, Baron EJ, Wexler HM, Finegold S, (2002) Anaerobic Bacteriology Manual, Wadsworth-KTL.

Layout table for additonal information
Responsible Party: Maribasappa Karched, Assistant Professor, Kuwait University
ClinicalTrials.gov Identifier: NCT02771704     History of Changes
Other Study ID Numbers: KuwaitU
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Fluorides
Chlorhexidine
Chlorhexidine gluconate
Iodine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances