Periodontal DiseasesNCT04399187
Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement
A study testing Sodium hypochlorite gel application in people with Periodontal Diseases, run by University of Messina at 1 site in Italy.
Trial summary
The aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (NaOCl) gel application after 6 months follow-up. Read more about this study
- Who is it for?
- Ages 32 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Sodium hypochlorite gel application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 15 Sep 2019
- 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 32 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with periodontitis;
- Age > 18 years old;
- Patients with at least 10 teeth for arch;
- Presence at least of two teeth with PD > 5 mm for quadrant;
- Single-rooted and multi-rooted teeth;
Who cannot join
- Patients with systemic diseases;
- Pregnant or lactating;
- Tobacco smokers (> 10 cigarettes/day);
- Previous periodontal treatment in the last 2 years;
- Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy;
- Furcation involvement;
- Acute periodontal or endodontic abscess;
- Third molars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effects of Adjunctive Local Sodium Hypochlorite Gel in Minimally Invasive Non Surgical Debridement (MINSD) of Periodontal Pockets. A 6-month Randomized Controlled Clinical Trial
The aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (NaOCl) gel application after 6 months follow-up.
Read the detailed description
Forty periodontal compromised patients were randomly allocated in two groups. Periodontal pockets > 5 mm in patients of test group were treated by MINSD and NaOCl gel application, meanwhile in patients of control group MINSD alone was performed. Full-mouth plaque score (FMPS) , Full-mouth bleeding score (FMBS), probing depth (PD), clinical attachment level (CAL) and gingival recession (GR) were assessed at baseline and after 6 months follow-up.
- Conditions
- Periodontal Diseases
- Being tested
- Sodium hypochlorite gel application
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hypochlorite gel applicationDrug
Also called Gel application
Patients treated by scaling and root planing and Sodium hypochlorite gel application, meanwhile in patients of control group scaling and root planing alone was performed.
| Study group | Role | What they receive |
|---|---|---|
| scaling and root planing, Sodium hypochlorite gel application | Experimental | Periodontal pockets > 5 mm in patients of test group were treated by scaling and root planing and Sodium hypochlorite gel application Receives: Drug: Sodium hypochlorite gel application |
| scaling and root planing alone | Placebo comparator | scaling and root planing alone was performed Receives: Drug: Sodium hypochlorite gel application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth changes
Changes over time in probing depth millimiters
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Apr 2018
- Primary completion1 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, DDS, PhD, University of Messina
- Investigators
- Gaetano Isola, Study chair, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399187
- Sponsor's protocol ID
- 16-18
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing study results
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Adjunctive Local Sodium Hypochlorite Gel in Minimally Invasive Non Surgical Debridement (MINSD) of Periodontal Pockets. A 6-month Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04399187
- Acronym / sponsor ID
- 16-18
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 22 May 2020 (actual)
- 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.
The aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (NaOCl) gel application after 6 months follow-up.
Detailed description
Forty periodontal compromised patients were randomly allocated in two groups. Periodontal pockets > 5 mm in patients of test group were treated by MINSD and NaOCl gel application, meanwhile in patients of control group MINSD alone was performed. Full-mouth plaque score (FMPS) , Full-mouth bleeding score (FMBS), probing depth (PD), clinical attachment level (CAL) and gingival recession (GR) were assessed at baseline and after 6 months follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scaling and root planing, Sodium hypochlorite gel application | Experimental | Drug: Sodium hypochlorite gel applicationPeriodontal pockets > 5 mm in patients of test group were treated by scaling and root planing and Sodium hypochlorite gel application |
| scaling and root planing alone | Placebo comparator | Drug: Sodium hypochlorite gel applicationscaling and root planing alone was performed |
Who may qualify
- Ages
- 32 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with periodontitis;
- Age > 18 years old;
- Patients with at least 10 teeth for arch;
- Presence at least of two teeth with PD > 5 mm for quadrant;
- Single-rooted and multi-rooted teeth;
Key exclusion criteria (8 listed)
- Patients with systemic diseases;
- Pregnant or lactating;
- Tobacco smokers (> 10 cigarettes/day);
- Previous periodontal treatment in the last 2 years;
- Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy;
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 |
|---|---|---|
| Sodium hypochlorite gel applicationAlso: Gel applicationPatients treated by scaling and root planing and Sodium hypochlorite gel application, meanwhile in patients of control group scaling and root planing alone was performed. | Drug | scaling and root planing alone, scaling and root planing, Sodium hypochlorite gel application |
Primary outcome
Probing depth changes
Time frame: 6-months
Changes over time in probing depth millimiters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: Yes. Sharing study results
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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.
Gaetano Isola study chair
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hypochlorite gel application in people with Periodontal Diseases, run by University of Messina at 1 site in Italy.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 22 May 2020. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 depth changes (time frame: 6-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 22 May 2020.