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

NCT07002632 | Completed Results

• 1 other identifier: 309 Anguler Cehilitis
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Cheilitis, Angular; Tonsillectomy; Adenoidectomy; Dexpanthenol; Pain; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Postoperative Pain Score

  Postoperative Day 1 and Postoperative Day 7

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Bepanthol Derma moisturizing cream

Dexpanthenol group

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 10472460 BACKGROUND

MeSH Terms

Conditions

Cheilitis; Postoperative Complications; Pain

Interventions

dexpanthenol; Ointments

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

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.

Results Point of Contact

• Title: Ethem ilhan, MD
• Organization: University of Health Sciences, Gaziosmanpasa Training and Research Hospital

ethem.ilhan@sbu.edu.tr

+90 505 591 86 50

Study Officials

• ethem ilhan, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor, a senior surgeon responsible for evaluating postoperative angular cheilitis and pain, was blinded to the treatment group allocation of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: July 20, 2021
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Locations

TU (1)