NCT02771704

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

May 1, 2016

Last Update Submit

June 8, 2016

Conditions

Dentine Caries

Outcome Measures

Primary Outcomes (1)

  • antibacterial activity measured by total viable counts after treatment

    Through study completion, an average of 3 months

Study Arms (5)

Silver diamine fluoride

EXPERIMENTAL

Intervention: Silver diamine fluoride will be applied in vivo on carious dentine lesions

Other: Silver Diamine fluoride

Potassium iodide

EXPERIMENTAL

Potassium iodide will be applied in vivo on carious dentine lesions.

Other: Potassium iodide

Chlorhexidine

EXPERIMENTAL

Chlorhexidine will be applied in vivo on carious dentine lesions

Other: Chlorhexidine

Silver diamine fluoride+Potassium iodide

EXPERIMENTAL

Silver diamine fluoride and potassium iodide mixture will be applied in vivo on carious dentine lesions

Other: Silver diamine fluoride and potassium iodide

Saline

EXPERIMENTAL

Sterile physiological saline will be applied in vivo on carious dentine lesions

Other: Physiological saline

Interventions

Silver Diamine fluorideOTHER
Silver diamine fluoride
Potassium iodideOTHER
Potassium iodide
ChlorhexidineOTHER
Chlorhexidine
Silver diamine fluoride and potassium iodideOTHER
Silver diamine fluoride+Potassium iodide
Physiological salineOTHER
Saline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

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

    BACKGROUND

  • Emilson CG, Bratthall D. Growth of Streptococcus mutans on various selective media. J Clin Microbiol. 1976 Jul;4(1):95-8. doi: 10.1128/jcm.4.1.95-98.1976.

    PMID: 956364BACKGROUND

MeSH Terms

Interventions

silver diamine fluoridePotassium IodideChlorhexidine

Intervention Hierarchy (Ancestors)

IodidesIodine CompoundsInorganic ChemicalsPotassium CompoundsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Maribasappa Karched, PhD

    Kuwait University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 1, 2016

First Posted

May 13, 2016

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06