Trial Outcomes & Findings for Using Dexpanthenol Cream to Prevent Lip Corner Cracks in Children After Tonsil/Adenoid Surgery (NCT NCT07002632)
NCT ID: NCT07002632
Last Updated: 2025-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Postoperative Day 1 and Postoperative Day 7
Results posted on
2025-07-02
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Control Group
Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
|
Overall Study
COMPLETED
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dexpanthenol Group
n=51 Participants
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.
|
Control Group
n=50 Participants
Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.65 years
STANDARD_DEVIATION 2.36 • n=51 Participants
|
5.96 years
STANDARD_DEVIATION 2.82 • n=50 Participants
|
6.31 years
STANDARD_DEVIATION 2.61 • n=101 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=51 Participants
|
20 Participants
n=50 Participants
|
45 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=51 Participants
|
30 Participants
n=50 Participants
|
56 Participants
n=101 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
51 Participants
n=51 Participants
|
50 Participants
n=50 Participants
|
101 Participants
n=101 Participants
|
|
Pre-operative Tonsil Grade
Grade 1
|
8 Participants
n=51 Participants
|
7 Participants
n=50 Participants
|
15 Participants
n=101 Participants
|
|
Pre-operative Tonsil Grade
Grade 2
|
14 Participants
n=51 Participants
|
14 Participants
n=50 Participants
|
28 Participants
n=101 Participants
|
|
Pre-operative Tonsil Grade
Grade 3
|
18 Participants
n=51 Participants
|
16 Participants
n=50 Participants
|
34 Participants
n=101 Participants
|
|
Pre-operative Tonsil Grade
Grade 4
|
11 Participants
n=51 Participants
|
13 Participants
n=50 Participants
|
24 Participants
n=101 Participants
|
|
Surgical Indication
Obstructive sleep apnea
|
14 Participants
n=51 Participants
|
13 Participants
n=50 Participants
|
27 Participants
n=101 Participants
|
|
Surgical Indication
Recurrent adenotonsillitis
|
10 Participants
n=51 Participants
|
6 Participants
n=50 Participants
|
16 Participants
n=101 Participants
|
|
Surgical Indication
Recurrent tonsillitis + obstructive sleep apnea
|
27 Participants
n=51 Participants
|
31 Participants
n=50 Participants
|
58 Participants
n=101 Participants
|
|
Mallampati Classification
class 1
|
43 Participants
n=51 Participants
|
39 Participants
n=50 Participants
|
82 Participants
n=101 Participants
|
|
Mallampati Classification
class 2
|
8 Participants
n=51 Participants
|
11 Participants
n=50 Participants
|
19 Participants
n=101 Participants
|
|
Mallampati Classification
class 3
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=101 Participants
|
|
Mallampati Classification
class 4
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=101 Participants
|
|
Vertical mouth opening length
|
4.48 centimeters
STANDARD_DEVIATION 0.70 • n=51 Participants
|
4.63 centimeters
STANDARD_DEVIATION 0.89 • n=50 Participants
|
4.55 centimeters
STANDARD_DEVIATION 0.80 • n=101 Participants
|
|
Mouth opener size
|
7.36 centimeters
STANDARD_DEVIATION 0.76 • n=51 Participants
|
7.01 centimeters
STANDARD_DEVIATION 1.15 • n=50 Participants
|
7.18 centimeters
STANDARD_DEVIATION 0.98 • n=101 Participants
|
|
Operation time
|
35.10 minutes
STANDARD_DEVIATION 14.39 • n=51 Participants
|
38.86 minutes
STANDARD_DEVIATION 18.53 • n=50 Participants
|
36.96 minutes
STANDARD_DEVIATION 16.59 • n=101 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 1 and Postoperative Day 7Population: 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.
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.
Outcome measures
| Measure |
Dexpanthenol Group
n=51 Participants
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.
|
Control Group
n=50 Participants
Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure.
|
|---|---|---|
|
Incidence of Angular Cheilitis
1st day Angular cheilitis pozitif
|
5 Participants
|
22 Participants
|
|
Incidence of Angular Cheilitis
1st day Angular cheilitis negative
|
46 Participants
|
28 Participants
|
|
Incidence of Angular Cheilitis
1st week Angular cheilitis pozitif
|
2 Participants
|
5 Participants
|
|
Incidence of Angular Cheilitis
1st week Angular cheilitis negative
|
49 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 1 and Postoperative Day 7Population: 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.
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).
Outcome measures
| Measure |
Dexpanthenol Group
n=51 Participants
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.
|
Control Group
n=50 Participants
Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure.
|
|---|---|---|
|
Postoperative Pain Score
1st day pain score
|
4.47 score on a scale
Standard Deviation 1.93
|
4.48 score on a scale
Standard Deviation 1.94
|
|
Postoperative Pain Score
1st week pain score
|
2.41 score on a scale
Standard Deviation 1.66
|
2.38 score on a scale
Standard Deviation 1.59
|
Adverse Events
Dexpanthenol Group
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexpanthenol Group
n=51 participants at risk
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.
|
Control Group
n=50 participants at risk
Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Angular Cheilitis
|
9.8%
5/51 • Number of events 5 • 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.
|
44.0%
22/50 • Number of events 22 • 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.
|
|
General disorders
Postoperative Pain
|
100.0%
51/51 • Number of events 51 • 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.
|
100.0%
50/50 • Number of events 50 • 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.
|
Additional Information
Ethem ilhan, MD
University of Health Sciences, Gaziosmanpasa Training and Research Hospital
Phone: +90 505 591 86 50
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place