Periodontitis, AdultPOLYVIDONENCT03432975
Evaluation of Multiple Subgingival Irrigations.
A study testing Povidone-Iodine 10% and Saline Solution in people with Periodontitis, Adult, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. Patients diagnosed with Generalized Chronic Periodontitis (GChP) based on the current classification of the American Academy of Periodontology will be included. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- Povidone-Iodine 10% and Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Dec 2017to 31 Aug 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 30 years of age
- At least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
- Any history of periodontal treatment in the previous 6 months
- No removable prosthesis
- A minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥5 mm
- At least 30% of the sites with PPD and CAL ≥4 mm and bleeding on probing (BOP)
Who cannot join
- Any sensitivity or allergy to any of the products that will be used in the study
- Thyroid dysfunction
- Systemic disease (ASA II or more)
- Need for antibiotic pre-medication for routine dental therapy
- Antibiotic therapy in the previous 3 months
- Pregnancy and breastfeeding
- Current smokers (more than 5 cigarettes a day)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Selena Toma, Parodontologist, 00322764 ext. 5714, selena.toma@uclouvain.be
Selma Kessler, Dentist, 00322764 ext. 5714, selma.kessler@uclouvain.be
About this study
Official title: Evaluation of Multiple Subgingival Irrigations With 10% Povidone Iodine After Scaling and Root Planing : a Randomized Clinical Trial
The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. Patients diagnosed with Generalized Chronic Periodontitis (GChP) based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.
Read the detailed description
The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. The patients will be informed in detail of the nature and course of study, and will sign informed consent prior to engagement in the study. Patients diagnosed with GChP based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.
- Conditions
- Periodontitis, Adult
- Being tested
- Povidone-Iodine 10%, Saline 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.
Povidone-Iodine 10%Drug
The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)
Saline SolutionDrug
The other side of the mouth will be irrigated with a sterile saline solution (control group)
| Study group | Role | What they receive |
|---|---|---|
| Povidone Iodine 10% | Experimental | The side of the mouth receiving the subgingival irrigations of povidone iodine. Receives: Drug: Povidone-Iodine 10% |
| Sterile saline solution | Placebo comparator | The other side of the mouth will be irrigated with a sterile saline solution. Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm
The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD).
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start18 Dec 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 patients (=40 half-mouth); 20 half-mouth per group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432975
- Sponsor's protocol ID
- 2017/06NOV/503
- Acronym
- POLYVIDONE
- Status last verified
- Jul 2019
- First submitted
- 8 Feb 2018
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multiple Subgingival Irrigations With 10% Povidone Iodine After Scaling and Root Planing : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03432975
- Acronym / sponsor ID
- POLYVIDONE / 2017/06NOV/503
- Conditions
- Periodontitis, Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 14 Feb 2018 (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 study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. Patients diagnosed with Generalized Chronic Periodontitis (GChP) based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.
Detailed description
The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. The patients will be informed in detail of the nature and course of study, and will sign informed consent prior to engagement in the study. Patients diagnosed with GChP based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 20 patients (=40 half-mouth); 20 half-mouth per group
| Arm | Type | Receives |
|---|---|---|
| Povidone Iodine 10% | Experimental | Drug: Povidone-Iodine 10%The side of the mouth receiving the subgingival irrigations of povidone iodine. |
| Sterile saline solution | Placebo comparator | Drug: Saline SolutionThe other side of the mouth will be irrigated with a sterile saline solution. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 30 years of age
- At least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
- Any history of periodontal treatment in the previous 6 months
- No removable prosthesis
- A minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥5 mm
Key exclusion criteria (7 listed)
- Any sensitivity or allergy to any of the products that will be used in the study
- Thyroid dysfunction
- Systemic disease (ASA II or more)
- Need for antibiotic pre-medication for routine dental therapy
- Antibiotic therapy in the previous 3 months
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 |
|---|---|---|
| Povidone-Iodine 10%The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group) | Drug | Povidone Iodine 10% |
| Saline SolutionThe other side of the mouth will be irrigated with a sterile saline solution (control group) | Drug | Sterile saline solution |
Primary outcome
Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm
Time frame: up to 6 months
The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine 10% and Saline Solution in people with Periodontitis, Adult, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Jul 2019. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selena Toma, Parodontologist (00322764 ext. 5714, selena.toma@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm (time frame: up to 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 15 Jul 2019.