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Effectiveness of a Chlorine Dioxide Spray on Dental Plaque and Respiratory Pathogens in Institutionalized Elders

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: NCT03533335
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Otto Lok-Tao Lam, The University of Hong Kong

Brief Summary:

The primary objective of this 6 month study is to compare the effectiveness of oral health promotion interventions on both clinical oral health, and oral opportunistic respiratory pathogens in institutionalized elders. Secondary objectives are to investigate changes in oral health-related quality of life, incidence of adverse side effects, pneumonia, as well as subject acceptability.

Elders residing in nursing homes in Hong Kong will be recruited into the clinical trial. Patients will be randomly allocated into one of the following groups: 0.2% chlorhexidine spray, 0.1% pH-balanced chlorine dioxide spray, or sterile water spray (placebo control), once daily. Dental plaque, gingival bleeding, oral opportunistic respiratory pathogens, oral health-related quality of life (OHRQoL), and pneumonia incidence will be assessed at baseline, 3 months and 6 months. Subject acceptability of the interventions will be assessed at the end of the clinical trial.


Condition or disease Intervention/treatment Phase
Oral Hygiene Frail Elderly Nursing Homes Chlorhexidine Other: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group 1: Oral spray (chlorhexidine) Group 2: Oral spray (chlorine dioxide) Group 3: Oral spray (water)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial on the Effect of a Chlorine Dioxide Spray on Dental Plaque and Respiratory Pathogens in Institutionalized Elders
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2017


Arm Intervention/treatment
Active Comparator: Chlorhexidine spray
0.2% chlorhexidine oral spray, once daily
Other: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray)
Application of a daily dose of 12 sprays (each delivering a volume of 0.13ml) to the buccal and lingual gingival third of tooth surfaces in each sextant

Experimental: Chlorine Dioxide spray
0.1% pH-balanced chlorine dioxide oral spray, once daily
Other: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray)
Application of a daily dose of 12 sprays (each delivering a volume of 0.13ml) to the buccal and lingual gingival third of tooth surfaces in each sextant

Placebo Comparator: Sterile water spray
Placebo
Other: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray)
Application of a daily dose of 12 sprays (each delivering a volume of 0.13ml) to the buccal and lingual gingival third of tooth surfaces in each sextant




Primary Outcome Measures :
  1. Change in dental plaque [ Time Frame: baseline to 6 months ]
    Change in dental plaque (Silness and Löe Plaque Index) from baseline to 3 months and 6 months


Secondary Outcome Measures :
  1. Change in gingival bleeding [ Time Frame: baseline to 6 months ]
    Change in gingival bleeding (Silness and Löe Gingival Bleeding Index) from baseline to 3 months, and 6 months

  2. Change in oral health-related quality of life [ Time Frame: baseline to 6 months ]
    Change in OHIP (Oral health impact profile) scores from baseline, to 3 months, and 6 months

  3. Aspiration pneumonia [ Time Frame: over 6 months ]
    Incidence of aspiration pneumonia

  4. Side effects [ Time Frame: Baseline to 6 months ]
    Supragingival calculus, extrinsic staining

  5. Change in Staphylococcus aureus [ Time Frame: Baseline to 6 months ]
    Change in S. aureus (cfu/ml), from baseline to 3 months, and 6 months

  6. Change in aerobic and facultative anaerobic Gram-negative bacilli [ Time Frame: Baseline to 6 months ]
    Change in aerobic and facultative anaerobic Gram-negative bacilli (cfu/ml), from baseline to 3 months, and 6 months

  7. Change in Streptococcus pneumoniae [ Time Frame: Baseline to 6 months ]
    Change in Streptococcus pneumoniae (cfu/ml), from baseline to 3 months, and 6 months

  8. Change in Haemophilus influenzae [ Time Frame: Baseline to 6 months ]
    Change in Haemophilus influenza (cfu/ml), from baseline to 3 months, and 6 months

  9. Change in Moraxella catarrhalis [ Time Frame: Baseline to 6 months ]
    Change in Moraxella catarrhalis (cfu/ml) from baseline to 3 months, and 6 months



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • not less than six natural teeth
  • not having an indwelling nasogastric tube

Exclusion Criteria:

-

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Responsible Party: Dr. Otto Lok-Tao Lam, Clinical assistant professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03533335    
Other Study ID Numbers: UW12-509
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Otto Lok-Tao Lam, The University of Hong Kong:
Oral Hygiene
Oral Sprays
Oral Health
Frail Elderly
Nursing Homes
Chlorhexidine
Chlorine Dioxide
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorine dioxide
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dental Disinfectants