Oral Mucosa; UlcerMUCOSA HEALINGNCT06531720
Comparison of the Effects of Oral Ulceration Healing in Patients Wearing a Removable Denture
A study testing Chlorhexidine Gluconate and Choline Salicylate 8.7 % Oral Gel in people with Oral Mucosa; Ulcer, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of the study was comparing the effectiveness of oral mucosa healing properties of different preparations: CHX=0,2% chorhexidine digluconate, CHS=8,7% choline salicylate, CON=control group, in patients with delivered removable dentures, during the adaptation period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Mucosa; Ulcer
- What is being tested?
- Chlorhexidine Gluconate and Choline Salicylate 8.7 % Oral Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- oral mucosa lesion OML as a result of new denture adaptation
- partial dentures II and III
- prostheses delivered for the during the period of the study patient
- patient consent
Who cannot join
- systemic conditions affecting the wound healing: diabetes
- prosthetic stomatitis according to Newton's classification
- parafunctional habits, bruxism
- autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Mucosa Tissue Healing in Patients Wearing a Removable Prosthetic Restoration - Pilot Study.
The aim of the study was comparing the effectiveness of oral mucosa healing properties of different preparations: CHX=0,2% chorhexidine digluconate, CHS=8,7% choline salicylate, CON=control group, in patients with delivered removable dentures, during the adaptation period.
Read the detailed description
The efficacy of oral topical medications in aiding regeneration and healing of oral soft mucosa, caused by the use of removable prosthetic restorations was analyzed. These medications, with different functional properties, are recommended for patients who develop oral mucosa lesions during adaptation to new removable prostheses. The evaluation of the efficacy of these agents was based on a comparison of the area of OML before and after the treatment. The study was designed to evaluate healing after the application of a topical medication containing 0.2% chlorhexidine digluconate and 8,7% choline salicylate as an active ingredient.
Patients were asked to use topical medication 3 times a day, applying the size of a pea on the oral mucosa lesion. Participants in groups CHX and CHS were instructed not to eat or drink for 1 hour following the application of medication because of its functional and antibacterial properties. Patients were asked to wear new dentures between control visits, even when they felt discomfort while using them. Patients in the control group were not using any topical medication. According to randomization patients suffering from oral mucosa lesion (OML) were divided into three groups.
Using a transparent millimeter grid superimposed on the OML, the Wound Surface Area (WSA) was measured in mm^2. A very precise measurement of the WSA was possible thanks to the use of a millimeter scale on the digital photo image. Every, even partially filled square was included in the area of the OML. Graphical analysis using Photo for Windows Software consisted of adding all the squares within which the OML was observed. All the intraoral images of OML have been taken in reproducible conditions (ambient light, lens and camera settings, distance 5 cm). This measurements were carried out during all check-up visits on day 0, 1, 4, 7 and 14.
- Conditions
- Oral Mucosa; Ulcer
- Being tested
- Chlorhexidine Gluconate, Choline Salicylate 8.7 % Oral Gel, control group
- Keywords
- prosthetic materials, functional properties, antibacterial properties, chlorhexidine, choline salicylate
- Medical subject headings
- Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
topical preparation applied on oral mucosa lesion containing 0,2% CHX
Choline Salicylate 8.7 % Oral GelDrug
topical preparation applied on oral mucosa lesion containing, ethanol-based
control groupOther
no medication has been prescribed
| Study group | Role | What they receive |
|---|---|---|
| 0,2% CHX topical use | Experimental | Patients were asked to use topical medication containing 0,2% chlorhexidine 3 times a day, applying the size of a pea on the oral mucosa lesion until full wound healing or up to 14 days. Receives: Drug: Chlorhexidine Gluconate |
| 8,7% CHS topical use | Experimental | Patients were asked to use topical medication containing 8,7% choline salicylate 3 times a day, applying the size of a pea on the oral mucosa lesion until full wound healing or up to 14 days. Receives: Drug: Choline Salicylate 8.7 % Oral Gel |
| Control | Experimental | Patients were not using any topical medications. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the effectiveness of oral mucosa lesion healing of different preparations
Using a transparent millimeter grid superimposed on the oral mucosa lesion, the Wound Surface Area (WSA) was measured in mm^2.
Measured: From baseline assessment up to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucosa; UlcerStudies 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
- According to randomization patients suffering from oral mucosa lesion (OML) were divided into three groups: * Group I: oral mucosa lesions treated with 0,2% CHX topical use, * Group II: oral mucosa lesions treated with 8,7% CHS topical use and * Group III: oral mucosa lesions as control group-CON with no specific OML treatment. The efficacy of oral topical medications in aiding regeneration and healing of oral soft mucosa, caused by the use of removable prosthetic restorations was analyzed. The evaluation of the efficacy of these agents was based on a comparison of the area of OML before and after the treatment. Patients in the control group were not using any topical medication.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531720
- Sponsor's protocol ID
- SUM MUCOSA HEALING
- Acronym
- MUCOSA HEALING
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 1 Aug 2024
- 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 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Mucosa Tissue Healing in Patients Wearing a Removable Prosthetic Restoration - Pilot Study.
- ClinicalTrials.gov ID
- NCT06531720
- Acronym / sponsor ID
- MUCOSA HEALING / SUM MUCOSA HEALING
- Conditions
- Oral Mucosa; Ulcer
- Keywords
- prosthetic materials, functional properties, antibacterial properties, chlorhexidine, choline salicylate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Aug 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.
The aim of the study was comparing the effectiveness of oral mucosa healing properties of different preparations: CHX=0,2% chorhexidine digluconate, CHS=8,7% choline salicylate, CON=control group, in patients with delivered removable dentures, during the adaptation period.
Detailed description
The efficacy of oral topical medications in aiding regeneration and healing of oral soft mucosa, caused by the use of removable prosthetic restorations was analyzed. These medications, with different functional properties, are recommended for patients who develop oral mucosa lesions during adaptation to new removable prostheses. The evaluation of the efficacy of these agents was based on a comparison of the area of OML before and after the treatment. The study was designed to evaluate healing after the application of a topical medication containing 0.2% chlorhexidine digluconate and 8,7% choline salicylate as an active ingredient.
Patients were asked to use topical medication 3 times a day, applying the size of a pea on the oral mucosa lesion. Participants in groups CHX and CHS were instructed not to eat or drink for 1 hour following the application of medication because of its functional and antibacterial properties. Patients were asked to wear new dentures between control visits, even when they felt discomfort while using them. Patients in the control group were not using any topical medication. According to randomization patients suffering from oral mucosa lesion (OML) were divided into three groups.
Using a transparent millimeter grid superimposed on the OML, the Wound Surface Area (WSA) was measured in mm^2. A very precise measurement of the WSA was possible thanks to the use of a millimeter scale on the digital photo image. Every, even partially filled square was included in the area of the OML. Graphical analysis using Photo for Windows Software consisted of adding all the squares within which the OML was observed. All the intraoral images of OML have been taken in reproducible conditions (ambient light, lens and camera settings, distance 5 cm). This measurements were carried out during all check-up visits on day 0, 1, 4, 7 and 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- According to randomization patients suffering from oral mucosa lesion (OML) were divided into three groups: * Group I: oral mucosa lesions treated with 0,2% CHX topical use, * Group II: oral mucosa lesions treated with 8,7% CHS topical use and * Group III: oral mucosa lesions as control group-CON with no specific OML treatment. The efficacy of oral topical medications in aiding regeneration and healing of oral soft mucosa, caused by the use of removable prosthetic restorations was analyzed. The evaluation of the efficacy of these agents was based on a comparison of the area of OML before and after the treatment. Patients in the control group were not using any topical medication.
| Arm | Type | Receives |
|---|---|---|
| 0,2% CHX topical use | Experimental | Drug: Chlorhexidine GluconatePatients were asked to use topical medication containing 0,2% chlorhexidine 3 times a day, applying the size of a pea on the oral mucosa lesion until full wound healing or up to 14 days. |
| 8,7% CHS topical use | Experimental | Drug: Choline Salicylate 8.7 % Oral GelPatients were asked to use topical medication containing 8,7% choline salicylate 3 times a day, applying the size of a pea on the oral mucosa lesion until full wound healing or up to 14 days. |
| Control | Experimental | Other: control groupPatients were not using any topical medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- oral mucosa lesion OML as a result of new denture adaptation
- partial dentures II and III
- prostheses delivered for the during the period of the study patient
- patient consent
Key exclusion criteria (4 listed)
- systemic conditions affecting the wound healing: diabetes
- prosthetic stomatitis according to Newton's classification
- parafunctional habits, bruxism
- autoimmune 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 |
|---|---|---|
| Chlorhexidine Gluconatetopical preparation applied on oral mucosa lesion containing 0,2% CHX | Drug | 0,2% CHX topical use |
| Choline Salicylate 8.7 % Oral Geltopical preparation applied on oral mucosa lesion containing, ethanol-based | Drug | 8,7% CHS topical use |
| control groupno medication has been prescribed | Other | Control |
Primary outcome
Comparing the effectiveness of oral mucosa lesion healing of different preparations
Time frame: From baseline assessment up to 2 weeks.
Using a transparent millimeter grid superimposed on the oral mucosa lesion, the Wound Surface Area (WSA) was measured in mm^2.
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 1 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Gluconate and Choline Salicylate 8.7 % Oral Gel in people with Oral Mucosa; Ulcer, run by Medical University of Silesia at 1 site in Poland.
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 4 inclusion and 4 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 1 Aug 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 Poland. 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. 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?
Comparing the effectiveness of oral mucosa lesion healing of different preparations (time frame: From baseline assessment up to 2 weeks.). 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 1 Aug 2024.