GingivitisNCT06224699
Toothpaste With Sodium Carbonate in Patients With Gingivitis
A study testing Toothpaste Product in people with Gingivitis and Periodontal Diseases, run by University of Catania at 1 site in Italy.
Trial summary
Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in gingivitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing Sodium carbonate 67% and fluoride toothpaste that contains no bicarbonate on patients… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontal Diseases
- What is being tested?
- Toothpaste Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 1 Mar 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically diagnosed with gingivitis according to the EFP/AAP 2017 criteria.
Who cannot join
- Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Systemic diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico Catania
Catania, 95124
Rosalia Leonardi, DDS, +0953782629, rleonardi@unict.it
About this study
Official title: Clinical and Antimicrobial Effectiveness of a Toothpaste With Sodium Carbonate in Patients With Gingivitis
Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in gingivitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing Sodium carbonate 67% and fluoride toothpaste that contains no bicarbonate on patients with gengivitis.
Read the detailed description
Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in both gingivitis and periodontitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing sodium carbonate at 67% or no sodium carbonate at 67% at 6-month follow-up in patients with gingivits. The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals.
- Conditions
- Gingivitis, Periodontal Diseases
- Being tested
- Toothpaste Product
- Medical subject headings
- Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste ProductDrug
Use of toothpaste with or without sodium carbonate at 67%
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Use of toothpaste with sodium carbonate 67% Receives: Drug: Toothpaste Product |
| Control | Placebo comparator | Use of toothpaste without sodium carbonate 67% Receives: Drug: Toothpaste Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index (1-4)
Gingival index reduction
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 posted25 Jan 2024
- Study start1 Sep 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals with gingivitis
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224699
- Sponsor's protocol ID
- 149/22/PO
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Antimicrobial Effectiveness of a Toothpaste With Sodium Carbonate in Patients With Gingivitis
- ClinicalTrials.gov ID
- NCT06224699
- Acronym / sponsor ID
- 149/22/PO
- Conditions
- Gingivitis, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in gingivitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing Sodium carbonate 67% and fluoride toothpaste that contains no bicarbonate on patients with gengivitis.
Detailed description
Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in both gingivitis and periodontitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing sodium carbonate at 67% or no sodium carbonate at 67% at 6-month follow-up in patients with gingivits. The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals with gingivitis
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Toothpaste ProductUse of toothpaste with sodium carbonate 67% |
| Control | Placebo comparator | Drug: Toothpaste ProductUse of toothpaste without sodium carbonate 67% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed with gingivitis according to the EFP/AAP 2017 criteria.
Key exclusion criteria (3 listed)
- Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Systemic diseases.
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 |
|---|---|---|
| Toothpaste ProductUse of toothpaste with or without sodium carbonate at 67% | Drug | Control, Test group |
Primary outcome
Gingival index (1-4)
Time frame: 6-months
Gingival index reduction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Yes. Study results
Related trials for Gingivitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
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 Toothpaste Product in people with Gingivitis and Periodontal Diseases, run by University of Catania 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 1 inclusion and 3 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 25 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival index (1-4) (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 25 Jan 2024.