Cheilitis, AngularPrevAC-PedATNCT07002632

Using Dexpanthenol Cream to Prevent Lip Corner Cracks in Children After Tonsil/Adenoid Surgery

A study testing Dexpanthenol 5 % Topical Ointment in people with Cheilitis, Angular and Postoperative Complications, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 15 years
Conditions the study is for: Cheilitis, Angular, Postoperative Complications, Adenotonsillar Hypertrophy
What is being tested?: Dexpanthenol 5 % Topical Ointment
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 Jul 2021to 5 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age between 3 and 15 years, inclusive
Scheduled for adenotonsillectomy (for indications such as obstructive sleep apnea and/or recurrent tonsillitis/adenotonsillitis).
Written informed consent provided by parents or legal guardians.

Who cannot join

Known allergy or hypersensitivity to dexpanthenol or any components of the cream.
Presence of angular cheilitis at the time of preoperative assessment.
Use of topical or systemic steroids or antibiotics within 4 weeks prior to surgery that might affect oral healing.
Participants with known systemic diseases or conditions that might impair wound healing (e.g., uncontrolled diabetes, immunosuppressive disorders).
Known diagnosis of iron deficiency and/or vitamin B12 deficiency prior to surgery.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Gaziosmanpasa Training and Research Hospital
Istanbul, 34255

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Preoperative Dexpanthenol Moisturizer on the Prevention of Angular Cheilitis After Pediatric Adenotonsillectomy: A Randomized Controlled Trial

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.

Conditions: Cheilitis, Angular, Postoperative Complications, Adenotonsillar Hypertrophy
Being tested: Dexpanthenol 5 % Topical Ointment
Keywords: Cheilitis, Angular, Tonsillectomy, Adenoidectomy, Dexpanthenol, Pain, Pediatrics
Medical subject headings: Cheilitis, Postoperative Complications, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexpanthenol 5 % Topical OintmentDrug
Also called Bepanthol Derma moisturizing cream
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.

Study groups in NCT07002632
Study group	Role	What they receive
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. Receives: Drug: Dexpanthenol 5 % Topical Ointment
Control group	No intervention	Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Postoperative Day 1 and Postoperative Day 7

Secondary outcomes (1)

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).
Measured: Postoperative Day 1 and Postoperative Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 20215 Jun 2024

First posted3 Jun 2025
Study start20 Jul 2021
Primary completion5 Jun 2024
Study completion5 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cheilitis, AngularStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07002632
Sponsor's protocol ID: 309 Anguler Cehilitis
Acronym: PrevAC-PedAT
Status last verified: Jun 2025
First submitted: 25 May 2025
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 10472460
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.
PubMed 41566030

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Preoperative Dexpanthenol Moisturizer on the Prevention of Angular Cheilitis After Pediatric Adenotonsillectomy: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07002632
Acronym / sponsor ID: PrevAC-PedAT / 309 Anguler Cehilitis
Conditions: Cheilitis, Angular, Postoperative Complications, Adenotonsillar Hypertrophy
Keywords: Cheilitis, Angular, Tonsillectomy, Adenoidectomy, Dexpanthenol, Pain, Pediatrics
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Gaziosmanpasa Research and Education HospitalOther government
Study start: 20 Jul 2021 (actual)
Primary completion: 5 Jun 2024 (actual)
Study completion: 5 Jun 2024 (actual)
First posted: 3 Jun 2025 (actual)
Results: Posted 2 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Dexpanthenol group	Experimental	Drug: Dexpanthenol 5 % Topical OintmentParticipants 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.

Who may qualify

Ages: 3 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Age between 3 and 15 years, inclusive
Scheduled for adenotonsillectomy (for indications such as obstructive sleep apnea and/or recurrent tonsillitis/adenotonsillitis).
Written informed consent provided by parents or legal guardians.

Key exclusion criteria (5 listed)

Known allergy or hypersensitivity to dexpanthenol or any components of the cream.
Presence of angular cheilitis at the time of preoperative assessment.
Use of topical or systemic steroids or antibiotics within 4 weeks prior to surgery that might affect oral healing.
Participants with known systemic diseases or conditions that might impair wound healing (e.g., uncontrolled diabetes, immunosuppressive disorders).
Known diagnosis of iron deficiency and/or vitamin B12 deficiency prior to surgery.

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
Dexpanthenol 5 % Topical OintmentAlso: Bepanthol Derma moisturizing creamDexpanthenol 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.	Drug	Dexpanthenol group

Primary outcome

Incidence of Angular Cheilitis
Time frame: Postoperative Day 1 and Postoperative Day 7
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.

1 secondary outcome

Postoperative Pain Score
Time frame: Postoperative Day 1 and Postoperative Day 7

Results and safety

Results posted to the registry on 2 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexpanthenol Group	53	51
Control Group	53	50

Primary outcome: Incidence of Angular Cheilitis

Time frame: Postoperative Day 1 and Postoperative Day 7. Count of participants. Unit: Participants

Measure	Dexpanthenol Group n = 51	Control Group n = 50
1st day Angular cheilitis pozitif	5	22
1st day Angular cheilitis negative	46	28
1st week Angular cheilitis pozitif	2	5
1st week Angular cheilitis negative	49	45

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the day of surgery to the final study follow-up on the seventh postoperative day.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexpanthenol Group	0 of 51 (0%)	51 of 51 (100%)	0 of 51
Control Group	0 of 50 (0%)	50 of 50 (100%)	0 of 50

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10472460England 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.
Derived from this study: PubMed 41566030Ilhan 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.

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.

ethem ilhan, MD principal investigator

Department of ENT, University of Health Sciences, Gaziosmanpasa TREH, Istanbul, Turkey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 5 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 2 Jul 2025. 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 Turkey (Türkiye). 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?

Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Angular Cheilitis (time frame: Postoperative Day 1 and Postoperative Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002632, which also lists 2 linked publications.

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 2 Jul 2025.