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

NCT03533335 | Completed Phase 4 DMC

• 1 other identifier: UW12-509
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Hygiene; Frail Elderly; Nursing Homes; Chlorhexidine

Keywords

Oral Hygiene; Oral Sprays; Oral Health; Frail Elderly; Nursing Homes; Chlorhexidine; Chlorine Dioxide

Outcome Measures

Primary Outcomes (1)

• Change in dental plaque

  Change in dental plaque (Silness and Löe Plaque Index) from baseline to 3 months and 6 months

  baseline to 6 months

Secondary Outcomes (9)

• Change in gingival bleeding

  baseline to 6 months

• Change in oral health-related quality of life

  baseline to 6 months

• Aspiration pneumonia

  over 6 months

• Side effects

  Baseline to 6 months

• Change in Staphylococcus aureus

  Baseline to 6 months

Study Arms (3)

Chlorhexidine spray

ACTIVE COMPARATOR

0.2% chlorhexidine oral spray, once daily

Other: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray)

Chlorine Dioxide spray

EXPERIMENTAL

0.1% pH-balanced chlorine dioxide oral spray, once daily

Other: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray)

Sterile water spray

PLACEBO COMPARATOR

Placebo

Other: Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray)

Interventions

Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray) OTHER

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

Chlorhexidine spray; Chlorine Dioxide spray; Sterile water spray

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Interventions

Oral Sprays

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Model Details: Group 1: Oral spray (chlorhexidine) Group 2: Oral spray (chlorine dioxide) Group 3: Oral spray (water)

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 23, 2018
• Study Start: June 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: May 23, 2018

Record last verified: 2018-05