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Soreness and cracking at the corners of the mouth, a condition called angular cheilitis, can be an uncomfortable problem for children after they have surgery to remove their tonsils and adenoids. This study looks at whether applying a moisturizing cream containing dexpanthenol to the corners of the mouth right before the surgery can help prevent this from happening.
The main idea (hypothesis)i the investigators are testing is that this dexpanthenol cream will protect the skin and reduce the number of children who get these painful lip sores after their operation.
To find this out, children who are scheduled to have tonsil and/or adenoid surgery will be invited to join the study. Children (participants) will be randomly placed into one of two groups by chance. One group of children will have the dexpanthenol cream applied to their lip corners just before their surgery. The other group will not have any cream applied to their lip corners before surgery. After the surgery, investigators will check all children to see if they have developed lip corner sores and compare how many children in each group experienced this problem.
The goal of this research is to see if this simple cream application can be an easy way to help children feel more comfortable while they are recovering from their surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexpanthenol group | Experimental | Participants in this arm received a single application of 5% dexpanthenol cream (water-in-oil emulsion) to both oral commissures. The cream was applied immediately before mouth gag insertion at the start of the adenotonsillectomy procedure. |
|
| Control group | No Intervention | Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexpanthenol 5 % Topical Ointment | Drug | Dexpanthenol is a topical agent, a derivative of pantothenic acid (a B-complex vitamin), used for its moisturizing and skin regenerative properties. The formulation studied was a 5% dexpanthenol in a water-in-oil emulsion. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Angular Cheilitis | Presence or absence of angular cheilitis determined by clinical examination. Angular cheilitis was defined as any inflammation, erythema, fissures, ulceration, or crusting at one or both oral commissures. Evaluations were performed by a senior surgeon blinded to treatment group allocation. | Postoperative Day 1 and Postoperative Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score | Pain intensity was assessed by the parents using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 (no hurt) to 10 (hurts worst). | Postoperative Day 1 and Postoperative Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ethem ilhan, MD | Department of ENT, University of Health Sciences, Gaziosmanpasa TREH, Istanbul, Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziosmanpasa Training and Research Hospital | Istanbul | 34255 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10472460 | Background | England RJ, Lau M, Ell SR. Angular cheilitis after tonsillectomy. Clin Otolaryngol Allied Sci. 1999 Aug;24(4):277-9. doi: 10.1046/j.1365-2273.1999.00255.x. | |
| 41566030 | Derived | Ilhan E, Onur F, Demir BS. Effect of preoperative topical dexpanthenol moisturizer on the prevention of angular cheilitis after pediatric adenotonsillectomy: a prospective randomized controlled trial. Eur Arch Otorhinolaryngol. 2026 Apr;283(4):2467-2473. doi: 10.1007/s00405-025-09981-x. Epub 2026 Jan 21. |
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No pre-assignment events, such as a run-in or washout period, occurred in this study. Enrolled participants were directly randomized to their assigned group after meeting the eligibility criteria.
Participants were recruited from the Department of Otorhinolaryngology at a single tertiary care center, Gaziosmanpasa Training and Research Hospital, in Istanbul, Turkey. The recruitment period for the study was between July 2021 and June 2024. Eligible participants were children aged 3 to 15 years who were scheduled for adenotonsillectomy and were identified during their routine preoperative clinical assessment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexpanthenol Group | Participants in this arm received a single application of 5% dexpanthenol cream (water-in-oil emulsion) to both oral commissures. The cream was applied immediately before mouth gag insertion at the start of the adenotonsillectomy procedure. Dexpanthenol 5 % Topical Ointment: Dexpanthenol is a topical agent, a derivative of pantothenic acid (a B-complex vitamin), used for its moisturizing and skin regenerative properties. The formulation studied was a 5% dexpanthenol in a water-in-oil emulsion. |
| FG001 | Control Group | Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 106 participants were initially enrolled and randomized into the study. However, five participants were lost to follow-up and their data were excluded from the final analysis. Therefore, the baseline characteristics are reported for the 101 participants who completed the study and were included in the analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexpanthenol Group | Participants in this arm received a single application of 5% dexpanthenol cream (water-in-oil emulsion) to both oral commissures. The cream was applied immediately before mouth gag insertion at the start of the adenotonsillectomy procedure. Dexpanthenol 5 % Topical Ointment: Dexpanthenol is a topical agent, a derivative of pantothenic acid (a B-complex vitamin), used for its moisturizing and skin regenerative properties. The formulation studied was a 5% dexpanthenol in a water-in-oil emulsion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Angular Cheilitis | Presence or absence of angular cheilitis determined by clinical examination. Angular cheilitis was defined as any inflammation, erythema, fissures, ulceration, or crusting at one or both oral commissures. Evaluations were performed by a senior surgeon blinded to treatment group allocation. | The analysis for this outcome measure was performed on all participants who completed the study. A total of 106 participants were initially randomized, but five were lost to follow-up. Therefore, the analysis population for this outcome consists of the 101 participants who completed the study. | Posted | Count of Participants | Participants | Postoperative Day 1 and Postoperative Day 7 |
|
From the day of surgery to the final study follow-up on the seventh postoperative day.
The systematic assessment was limited to the pre-specified primary outcome (incidence of angular cheilitis) and secondary outcome (postoperative pain). No other adverse events were systematically monitored or recorded as part of the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexpanthenol Group | Participants in this arm received a single application of 5% dexpanthenol cream (water-in-oil emulsion) to both oral commissures. The cream was applied immediately before mouth gag insertion at the start of the adenotonsillectomy procedure. Dexpanthenol 5 % Topical Ointment: Dexpanthenol is a topical agent, a derivative of pantothenic acid (a B-complex vitamin), used for its moisturizing and skin regenerative properties. The formulation studied was a 5% dexpanthenol in a water-in-oil emulsion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angular Cheilitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Localized inflammation, erythema or crusting at the corner of the mouth |
A precise a priori power analysis was not feasible due to limited prior literature. The study's single-center design may limit the generalizability of the findings. The short, seven-day follow-up period does not allow for assessment of long-term effects. Finally, the parent-reported rating scale for the secondary outcome of pain introduces a degree of subjectivity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ethem ilhan, MD | University of Health Sciences, Gaziosmanpasa Training and Research Hospital | +90 505 591 86 50 | ethem.ilhan@sbu.edu.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2021 | Jun 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002613 | Cheilitis |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C007288 | dexpanthenol |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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This was a parallel-group, randomized, controlled trial. Participants were randomly assigned to one of two arms: an intervention group receiving preoperative dexpanthenol moisturizer or a control group receiving no preoperative topical intervention. Participants remained in their assigned group for the duration of the study.
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The outcome assessor, a senior surgeon responsible for evaluating postoperative angular cheilitis and pain, was blinded to the treatment group allocation of the participants.
|
| BG001 | Control Group | Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pre-operative Tonsil Grade | Pre-operative tonsil grade was assessed using the Brodsky grading scale. This clinical scale categorizes tonsil size based on the proportion of the oropharyngeal airway occupied by the tonsils: Grade 1 = <25%, Grade 2 = 25-50%, Grade 3 = 50-75%, and Grade 4 = >75%. Higher grades indicate more severe tonsillar hypertrophy. | Count of Participants | Participants |
|
| Surgical Indication | Count of Participants | Participants |
|
| Mallampati Classification | Mallampati classification was used to assess the visibility of oropharyngeal structures when the patient opened their mouth and protruded the tongue. The scale includes four classes:
| Count of Participants | Participants |
|
| Vertical mouth opening length | Mean | Standard Deviation | centimeters |
|
| Mouth opener size | Mean | Standard Deviation | centimeters |
|
| Operation time | Mean | Standard Deviation | minutes |
|
| OG001 | Control Group | Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure. |
|
|
| Secondary | Postoperative Pain Score | Pain intensity was assessed by the parents using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 (no hurt) to 10 (hurts worst). | The analysis for this outcome measure was performed on all participants who completed the study. A total of 106 participants were initially enrolled, but five were lost to follow-up. Therefore, the analysis population for this outcome consists of the 101 participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 1 and Postoperative Day 7 |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 51 |
| 51 |
| EG001 | Control Group | Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure. | 0 | 50 | 0 | 50 | 50 | 50 |
|
| Postoperative Pain | General disorders | Systematic Assessment | Pain was evaluated using the Wong-Baker FACES Pain Rating Scale (0-10) on postoperative days 1 and 7. All participants reported some level of postoperative pain, which was expected and non-serious. |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Grade 3 |
|
| Grade 4 |
|
| Recurrent tonsillitis + obstructive sleep apnea |
|
| class 3 |
|
| class 4 |
|