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NCT Number: NCT07002632

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

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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Key information

Conditions

Cheilitis, Angular Adenotonsillar Hypertrophy Cheilitis Lip Diseases Mouth Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomatognathic Diseases

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Training and Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Bepanthol Derma moisturizing cream

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Pain Score

    Time frame: Postoperative Day 1 and Postoperative Day 7

    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).

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

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

Acronym: PrevAC-PedAT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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