Chronic PeriodontitisNCT02316652
Effect of Disinfective Solution as an Adjunct to Maintenance Therapy of Inflamed Periodontal Pockets
A study testing Scaling and root planing and Scaling and root planing with solution in people with Chronic Periodontitis, run by University of Nebraska at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Scaling and root planing and Scaling and root planing with solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2014to 22 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontal maintenance patients, have at least one pocket greater than or equal to 5 mm with bleeding on probing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Chemical Pocket Disinfection as an Adjunct to Non-surgical Maintenance Therapy of Inflamed Periodontal Pockets
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.
- Conditions
- Chronic Periodontitis
- Being tested
- Scaling and root planing, Scaling and root planing with solution
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Mechanical instrumentation
Scaling and root planing with solutionProcedure or surgery
Mechanical instrumentation with sodium hypochlorite disinfective solution
| Study group | Role | What they receive |
|---|---|---|
| Healthy sites | No intervention | Healthy sites with no inflammation; observational only |
| Scaling and root planing sites | Placebo comparator | Inflamed pocket receiving mechanical instrumentation Receives: Procedure: Scaling and root planing |
| Scaling and root planing with solution | Active comparator | Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution Receives: Procedure: Scaling and root planing with solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depths
Periodontal probing depth (PD)
Measured: 3 months
Secondary outcomes (3)
Bleeding on probing
Incidence of bleeding during probing
Measured: 3 months
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
Measured: 3 months
Inflammatory markers
Measure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study start15 Jan 2014
- Primary completion22 Nov 2016
- Study completion22 Nov 2016
Why it stopped: Study stopped and was not completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne Kaldahl, DDS, Study director, UNMC College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316652
- Sponsor's protocol ID
- 0636-13-FB
- Status last verified
- Aug 2023
- First submitted
- 8 Dec 2014
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Chemical Pocket Disinfection as an Adjunct to Non-surgical Maintenance Therapy of Inflamed Periodontal Pockets
- ClinicalTrials.gov ID
- NCT02316652
- Acronym / sponsor ID
- 0636-13-FB
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped and was not completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 15 Jan 2014 (actual)
- Primary completion
- 22 Nov 2016 (actual)
- Study completion
- 22 Nov 2016 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy sites | No intervention | –Healthy sites with no inflammation; observational only |
| Scaling and root planing sites | Placebo comparator | Procedure: Scaling and root planingInflamed pocket receiving mechanical instrumentation |
| Scaling and root planing with solution | Active comparator | Procedure: Scaling and root planing with solutionInflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Periodontal maintenance patients, have at least one pocket greater than or equal to 5 mm with bleeding on probing
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and root planingMechanical instrumentation | Procedure or surgery | Scaling and root planing sites |
| Scaling and root planing with solutionMechanical instrumentation with sodium hypochlorite disinfective solution | Procedure or surgery | Scaling and root planing with solution |
Primary outcome
Probing depths
Time frame: 3 months
Periodontal probing depth (PD)
3 secondary outcomes
Bleeding on probing
Time frame: 3 months
Clinical attachment level
Time frame: 3 months
Inflammatory markers
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Study stopped and was not completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Kaldahl, DDS study director
UNMC College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing and Scaling and root planing with solution in people with Chronic Periodontitis, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study stopped and was not completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depths (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.