Clinical trial NCT07002632
Conditions: Cheilitis, Angular Postoperative Complications Adenotonsillar Hypertrophy
Keywords: Cheilitis, Angular Tonsillectomy Adenoidectomy Dexpanthenol Pain Pediatrics
Sponsor: Gaziosmanpasa Research and Education Hospital
Start date: 2021-07-20; Completion date: 2024-06-05
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:

Arms: arm 1: 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. arm 2: Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure.
Interventions: intervention 1: Dexpanthenol 5 % Topical Ointment
Intervention descriptions: intervention 1: 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.

Protocol documents:
Prot_SAP_000.pdf: 
Official Title: Effect of Preoperative Dexpanthenol Moisturizer on the Prevention of 
Angular Cheilitis After Pediatric Adenotonsillectomy: A Randomized Controlled Trial  
 
NCT Number: NCT07002632 
 
 Document Date: July 7, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


MATERIALS AND METHODS   
This prospective, randomized, controlled study was designed and conducted in strict 
adherence to the ethical principles of the Declaration of Helsinki. The study protocol was 
approved by the institutional ethics committee (approval date: 07.07.2021; number: 309) and 
written informed consent was obtained from patients’ parents. This study was designed and 
reported in compliance with the CONSORT (Consolidated Standards of Reporting Trials) 
guidelines for randomized controlled trials. A CONSORT flow diagram illustrating the 
progress of participants through the trial phases is included (Figure 1). Given the limited prior 
literature, confined to a single pilot study by England et al. [4], a precise power analysis was 
not feasible. Initially, the target sample size was set at 60 patients over a 3-year period. To 
enhance statistical power, enrollment continued throughout the planned period, ultimately 
yielding a sample of 106 participants. 
A total of 106 children aged 3-15 years scheduled for adenotonsillectomy between July 
2021 and July 2024 at a tertiary referral ENT facility were enrolled in the study. Patients were 
randomized into study and control groups using computer-generated random numbers. In the 
study group, a water-in-oil emulsion formula containing 5% dexpanthenol (Bepanthol® Derma 
moisturizing cream, Bayer Türk Kimya San. Ltd. Şti. İstanbul, Türkiye) was administered to 
both oral commissures as a moisturizer immediately before mouth gag insertion while the 
control group received no cream. The Brodsky Grading Scale was used to assess pre-operative 
tonsillar hypertrophy. Pre-operative Mallampati scores of patients were also recorded. The 
conventional cold steel tonsillectomy technique was preferred in all patients to ensure 
consistency. Under the supervision of the same senior surgeon, all surgeries were performed 
by the same resident. Under general anesthesia, the Boyle Davis mouth gag was inserted. The 
size of the tongue depressor of the Boyle Davis mouth gag was recorded. Prior to incision, the 
distance between the upper and lower central incisors was measured using a ruler. 


Adenoidectomy was performed first using a standard curette technique under direct 
visualization with a mirror. Following excision of adenoid tissue, gauze packs were placed in 
the nasopharynx to achieve hemostasis and bipolar cautery was applied when necessary. 
Subsequently, tonsillectomy was performed using the cold steel dissection technique. Once the 
pericapsular plane was identified, the tonsils were dissected bluntly and excised. Bipolar 
electrocoagulation and nonabsorbable 2.0 silk ties were utilized simultaneously to manage 
hemorrhage in all surgeries. The inferior tonsil poles were consistently ligated with 2.0 silk 
ties. The surgical time was recorded. A single dose of prophylactic cefazolin sodium (25 
mg/kg) was administered parenterally to all patients preoperatively, and in the postoperative 
period, all patients received oral paracetamol suspension (20 mg/kg) three times daily for pain 
control.  
Postoperative evaluations were conducted by a senior surgeon who was unaware of the 
patients' group assignments. On the first postoperative day, patients were assessed for the 
presence of AC and the severity of pain. The presence of AC was assessed and recorded as 
either present or absent. Pain intensity was evaluated by the patients' parents by utilizing the 
Wong-Baker Faces Pain Rating Scale, which ranges from 0 to 10 points.  All patients 
underwent reevaluation for the same measures on the seventh day postoperatively.   
 
Statistical Analysis  
Statistical analyses were conducted using the Statistical Package for the Social Sciences 
(SPSS) version 26.0 (IBM Corp., Armonk, NY, USA; RRID:SCR_002865). Categorical 
variables were presented as frequencies and percentages (%). Numerical variables were 
expressed as mean and standard deviation (SD). The comparison of categorical variables was 
performed using the Pearson Chi-Square test. The normality of numerical variables was 
assessed using the Kolmogorov-Smirnov test, and variables following a normal distribution 


were compared using the Independent Samples T-Test. Binary logistic regression analysis was 
used to evaluate the independent effect of topical dexpanthenol use on the occurrence of AC 
on postoperative first day and first week. Odds ratios (ORs) with 95% confidence intervals 
(CIs) were calculated. The model's explanatory power was assessed using Nagelkerke R². A p-
value less than 0.05 was considered statistically significant.