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Effect of Disinfective Solution as an Adjunct to Maintenance Therapy of Inflamed Periodontal Pockets

Using Chemical Pocket Disinfection as an Adjunct to Non-surgical Maintenance Therapy of Inflamed Periodontal Pockets

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02316652
Enrollment
33
Registered
2014-12-15
Start date
2014-01-15
Completion date
2016-11-22
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Brief summary

This study will determine whether the supplemental use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation.

Detailed description

The purpose of this study is to determine whether the adjunctive use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation, as indicated by presence of pro- and anti-inflammatory cytokines, compared to scaling and root planing alone. The chemical pocket disinfection therapy consists of delivering a sodium hypochlorite solution followed by a neutralizing citric acid solution to the test site. Pro-inflammatory interleukin-1 beta and anti-inflammatory interleukin-1 receptor antagonist will be measured from the gingival crevicular fluid sampled from sites of interest.

Interventions

PROCEDUREScaling and root planing

Mechanical instrumentation

PROCEDUREScaling and root planing with solution

Mechanical instrumentation with sodium hypochlorite disinfective solution

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Periodontal maintenance patients, have at least one pocket greater than or equal to 5 mm with bleeding on probing

Exclusion criteria

* Uncontrolled diabetics * Regular users of nonsteroidal antiinflammatory drugs * Individuals on anti-coagulants * Individuals that have used antibiotics in the previous 3 months or require prophylactic antibiotic coverage * Pregnant individuals

Design outcomes

Primary

MeasureTime frameDescription
Probing depths3 monthsPeriodontal probing depth (PD)

Secondary

MeasureTime frameDescription
Bleeding on probing3 monthsIncidence of bleeding during probing
Clinical attachment level3 monthsClinical attachment level is calculated by adding gingival recession to probing depth; measures the connective tissue and epithelial attachment level relative to the cementoenamel junction
Inflammatory markers3 monthsMeasure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026