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3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
NA trial testing No SLS toothpaste in Oral Mucosal Disorder in 53 participants. Terminated before completion.
| Lead sponsor | Solventum US LLC |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 53 |
| Start date | 6 January 2020 |
| Primary completion | 10 March 2020 |
| Estimated completion | 10 March 2020 |
| Sites | 1 location across United States |
Solventum US LLC — full company profile →
Adults 18 to 90, any sex, with Oral Mucosal Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.
| Group | Value | 95% CI |
|---|---|---|
| Comparator: No SLS Toothpaste | 15 | |
| Comparator: Medium SLS Toothpaste | 14 | |
| Comparator: High SLS Toothpaste | 13 |
Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)
| Group | Value | 95% CI |
|---|---|---|
| Comparator: No SLS Toothpaste | 8 | |
| Comparator: Medium SLS Toothpaste | 6 | |
| Comparator: High SLS Toothpaste | 7 | |
| Comparator: No SLS Toothpaste | 9 | |
| Comparator: Medium SLS Toothpaste | 8 | |
| Comparator: High SLS Toothpaste | 6 | |
| Comparator: No SLS Toothpaste | 1 | |
| Comparator: Medium SLS Toothpaste | 3 | |
| Comparator: High SLS Toothpaste | 2 | |
| Comparator: No SLS Toothpaste | 0 | |
| Comparator: Medium SLS Toothpaste | 0 | |
| Comparator: High SLS Toothpaste | 1 |
Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)
| Group | Value | 95% CI |
|---|---|---|
| Comparator: No SLS Toothpaste | 6 | |
| Comparator: Medium SLS Toothpaste | 9 | |
| Comparator: High SLS Toothpaste | 7 | |
| Comparator: No SLS Toothpaste | 9 | |
| Comparator: Medium SLS Toothpaste | 6 | |
| Comparator: High SLS Toothpaste | 6 | |
| Comparator: No SLS Toothpaste | 3 | |
| Comparator: Medium SLS Toothpaste | 2 | |
| Comparator: High SLS Toothpaste | 2 | |
| Comparator: No SLS Toothpaste | 0 | |
| Comparator: Medium SLS Toothpaste | 1 | |
| Comparator: High SLS Toothpaste | 1 |
Subjects were questioned regarding how acceptable were your side effects. Using the following responses of: Completely unacceptable, somewhat unacceptable, somewhat acceptable, completely acceptable, did not experience side effects
| Group | Value | 95% CI |
|---|---|---|
| Comparator: No SLS Toothpaste | 2 | |
| Comparator: Medium SLS Toothpaste | 1 | |
| Comparator: High SLS Toothpaste | 2 | |
| Comparator: No SLS Toothpaste | 2 | |
| Comparator: Medium SLS Toothpaste | 0 | |
| Comparator: High SLS Toothpaste | 1 | |
| Comparator: No SLS Toothpaste | 1 | |
| Comparator: Medium SLS Toothpaste | 4 | |
| Comparator: High SLS Toothpaste | 4 | |
| Comparator: No SLS Toothpaste | 1 | |
| Comparator: Medium SLS Toothpaste | 4 | |
| Comparator: High SLS Toothpaste | 3 |
Time frame: Within 3 weeks of starting treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Comparator: No SLS Toothpa… | Comparator: Medium SLS Too… | Comparator: High SLS Tooth… |
|---|---|---|---|---|
| Oral mucosal exfoliation | Gastrointestinal disorders | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — |
| Dysgeusia | Gastrointestinal disorders | — | — | — |
| Hypoaesthesia oral | Gastrointestinal disorders | — | — | — |
| Mouth injury | Gastrointestinal disorders | — | — | — |
| Aphthous ulcer | Gastrointestinal disorders | — | — | — |
| Breath odor | Gastrointestinal disorders | — | — | — |
| Buccal mucosal roughening | Gastrointestinal disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Glossitis | Gastrointestinal disorders | — | — | — |
| Hyperaesthesia teeth | Gastrointestinal disorders | — | — | — |
| Oral discomfort | Gastrointestinal disorders | — | — | — |
| Oral pain | Gastrointestinal disorders | — | — | — |
| Salivary hypersecretion | Gastrointestinal disorders | — | — | — |
| Sensitivity of teeth | Gastrointestinal disorders | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — |
| Tongue biting | Gastrointestinal disorders | — | — | — |
| Tongue exfoliation | Gastrointestinal disorders | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
| Ligament sprain | Musculoskeletal and connective tissue disorders | — | — | — |
| Device failure | Product Issues | — | — | — |
Data from ClinicalTrials.gov NCT04601103 adverse events section.
The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.
No peer-reviewed publications indexed yet for this trial.
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