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TerminatedNCT02316652Updated Aug 24, 2023

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

An interventional study of Scaling and root planing and Scaling and root planing with solution in Chronic Periodontitis, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment

Why this study was terminated
Study stopped and was not completed

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2014, registered Dec 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
30 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 33 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
33 participants (actual)

Study arms

  • No intervention
    Healthy sites

    Healthy sites with no inflammation; observational only

  • Placebo comparator
    Scaling and root planing sites

    Inflamed pocket receiving mechanical instrumentation

    Procedure: Scaling and root planing

  • Active comparator
    Scaling and root planing with solution

    Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution

    Procedure: Scaling and root planing with solution

Interventions

  • ProcedureScaling and root planing

    Mechanical instrumentation

  • ProcedureScaling and root planing with solution

    Mechanical instrumentation with sodium hypochlorite disinfective solution

06

What researchers measure

Primary outcomes

  1. Probing depths

    Periodontal probing depth (PD)

    Time frame: 3 months

Secondary outcomes

  1. Bleeding on probing

    Incidence of bleeding during probing

    Time frame: 3 months

  2. Clinical attachment level

    Clinical attachment level is calculated by adding gingival recession to probing depth; measures the connective tissue and epithelial attachment level relative to the cementoenamel junction

    Time frame: 3 months

  3. Inflammatory markers

    Measure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest

    Time frame: 3 months

07

Study locations

1 site
  • UNMC College of Dentistry
    Lincoln, Nebraska 68583, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02316652
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Dec 15, 2014
Start date
Jan 15, 2014
Primary completion
Nov 22, 2016
Completion
Nov 22, 2016
Last update
Aug 24, 2023

Study contacts

Wayne Kaldahl, DDS
study director · UNMC College of Dentistry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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