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result(s) for
"Lip - surgery"
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Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial
by
Wallace, Christopher Glenn
,
Chang, Chee-Jen
,
Chen, Philip Kuo-Ting
in
Adult
,
Adults
,
Botulinum toxin
2014
Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds.
In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30) or vehicle (normal saline; n = 30) injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) and photographic plus ultrasound measurements of scar widths.
58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group.
Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing.
ClinicalTrials.gov NCT01429402.
Journal Article
Functional and aesthetic results of the Z-shaped and straight lower lip-splitting incision: a randomized clinical trial
2024
The lip-splitting approach enables excellent access to all areas of the mouth and pharynx to remove tumors; however, traditional lower lip-splitting incisions produce an unsatisfactory scar. To achieve better functional and aesthetic results, we used a Z-shaped incision and compared the functional and aesthetic outcomes of the straight and Z-shaped incisions. Sixty patients who fulfilled the inclusion criteria were randomly divided into two groups and underwent lip-splitting between March 2021 and September 2023. Eventually, 77 patients were reviewed within 6 months and evaluated using the lip function assessment scale, patient and observer scar assessment scale, naïve observer scar assessment scale, and a clinical examination. The Z-shaped incision group performed better in terms of the lip pout movement at 3 months and in the subjective overall opinion, color, irregularity, and pigmentation at 6 months. The Z-shaped incision group had a lower incidence of notched vermilion. In conclusion, Z-shaped lower lip-splitting incisions have better functional and aesthetic outcomes than traditional straight incisions.
Trial registration:
Public title: Difference between the effect of Z-shaped and vertical incisions of labiobuccal flap on the recovery of lower lip scars. Registration date: 09/03/2021. Registration number: ChiCTR2100044084. Registry URL:
http://www.chictr.org.cn
.
Journal Article
How does the nasolabial change in patients with unilateral cleft lip and/or palate following primary repair using a modified rotation-advancement technique: a 5-year anthropometry study
2025
This retrospective study analyzed nasolabial changes in 69 patients who underwent primary cleft repair using a modified rotation-advancement technique. Photogrammetric measurements were taken preoperatively (T0), immediately postoperatively (T1), one year postoperatively (T2), and five years postoperatively (T3). The ratio of labial width decreased from T2 to T3. The medial-oblique labial height on the affected side showed growth from T1 to T2 but slowed by T3. The ratio of lateral-oblique labial height remained stable and the crista philtra height symmetry improved. However, the ratios of nasal sill, heminasal, and nostril width decreased c onsistently from T1 to T3. The nostril height grew near-symmetrically from T1 to T2, with acceleration thereafter, yet still smaller than the unaffected side at T3. The nostril area on the affected side grew more slowly. The nasal tip deviation angle changed minimally at T2 but showed medial displacement by T3. The columellar angle remained stable, while the affected columellar height showed delayed growth and remained shorter than the unaffected side at T3. There were no significant differences in nasolabial growth between patients with or without cleft palate/alveolar, and complete cleft lips displayed similar growth patterns to those of incomplete forms. In conclusion, to achieve symmetry of the nasal sill and nostril, an overcorrection of the alar base and alar contour on the cleft side was necessary during primary repair. Additionally, the initial severity of the deformity had minimal impact on long-term surgical outcomes.
Journal Article
Unilateral and bilateral ex vivo cleft lip models: universal tools for surgical training at different levels of experience
2025
Introduction
Our group has recently established the first ex vivo cadaveric models to simulate unilateral and bilateral cleft lip surgery. We have shown that these porcine snout disc models are suitable for novice cleft surgeons to understand the basic principles of cleft lip surgery and to practice the essential surgical steps. In this study we want to show that the ex vivo cleft lip models are not only suitable and helpful for residents, but also for students and experienced surgeons with and without experience in cleft surgery.
Methods
Three courses were held to evaluate the ex vivo cleft lip models: One for oral and maxillofacial surgeons from German cleft centers and two courses for dental students. All operated on the unilateral and bilateral ex vivo cleft lip models using the Millard technique. Questionnaires were used to assess their subjective opinion of the ex vivo cleft lip models. Tasks for the students were carried out to objectify their learning success. Three-dimensional scans were taken and analyzed using a previously validated intraoral scanner to objectively assess the outcome.
Results
The ex vivo cleft lip models are suitable for the training of students and experienced surgeons with varying levels of experience in cleft lip repair. Both models were rated as realistic in terms of tissue resemblance, surgical planning, and surgical management. In addition, the specialists rated the models as realistic overall. The models also provide students with several advantages, such as improved surgical skills and a better understanding of cleft surgery. Participants felt that the models should be made available not only to residents, but also to consultants and senior consultants and should be implicated in the dental curriculum.
Conclusion
The ex vivo cleft lip models made of porcine snout discs are suitable for a wide range of users starting from students to experienced surgeons to train in cleft lip surgery. The great advantage of these models is that experienced surgeons can work with an inexpensive and readily available model to improve their skills and modify their techniques.
Journal Article
Emergence agitation in pediatrics after dexmedetomidine vs. sevoflurane anesthesia: A randomized controlled trial
by
Yahya, Corry Quando
,
Santoso, Kohar Hari
,
Semedi, Bambang Pujo
in
Adrenergic receptors
,
Agitation
,
Anesthesia
2025
Emergence agitation remains a problem that occurs in pediatric anesthesia. As cleft surgeries constitute one of the most common craniofacial surgeries encountered, majority of the children receive general anesthesia using high dose opioids and inhalation anesthetics and experience emergence agitation. Dexmedetomidine (DEX), an alpha-2 adrenoreceptor agonist possesses anxiolytic, sedative and analgetic properties and have been documented to reduce the incidence of postoperative agitation. Hence, this study aims to compare the incidence of emergence agitation between the use of intravenous DEX versus Sevoflurane (SEVO) anesthesia.
This study selected one hundred twenty-one patients ages 3 months to 10 years with ASA 1 and 2 physical status scheduled to undergo elective cleft lip or cleft palate repair with general anesthesia. Before surgery, all patients were assessed preoperatively and subjects were divided into two groups using a computer-generated randomizer with 59 subjects selected as Dexmedetomidine group; and 62 subjects as Sevoflurane group. Extubation time, recovery time and emergence agitation scale were compared between the two groups.
This study found no significant difference in the extubation time between DEX and SEVO group (p = 0.317). The recovery time or time to attain full consciousness was statistically longer in the DEX group: 60 minutes as compared to 52 minutes in the SEVO group (p = 0.007). Emergence agitation assessed using Cravero score found that subjects from DEX group had an average Cravero score of 2.5; while SEVO group had an average Cravero score of 3.9 (p = < 0.001). The incidence of agitation was significantly higher in the SEVO group compared to the DEX group: 82% as compared to 10% (p = < 0.001) with an OR of 40.955 CI 95% (14.098-118.9).
Dexmedetomidine significantly reduces the incidence of emergence agitation without prolonging extubation time in pediatric patients undergoing cleft lip and cleft palate surgery.
Journal Article
Nasoalveolar Molding in Cleft Care—Experience in 40 Patients from a Single Centre in Germany
by
Ritschl, Lucas M.
,
Loeffelbein, Denys J.
,
Mücke, Thomas
in
Anthropometry
,
Casts
,
Cleft Lip - pathology
2015
Nasoalveolar molding (NAM) has gained wide acceptance and evidence in cleft therapy. However, standardized treatment protocols and experiences recorded from European centres are lacking. The results of 40 infants with cleft lip and palate treated with presurgical NAM according to the Grayson technique were analyzed. Standardized parameters of cleft width and nasal symmetry were measured in pre- and posttreatment plaster casts and in digitalized 3-dimensional STL models. Statistical analyses were performed by using Student's t-test in a per-protocol manner. 27 out of 40 infants completed NAM and were analyzed. In 13 patients NAM was either temporarily interrupted or terminated prematurely due to skin irritations or lack of parental support. These cases were excluded from statistical analysis, resulting in a drop-out rate of 32.5%. Intersegmental alveolar distance (ISAD), intersegmental lip distance (ISLD), nostril height (NH), nostril width (NW) and columella deviation angle (CDA) were significantly changed in unilateral cleft lip and palate (UCLP) (n = 8). In unilateral cleft lip (UCL) (n = 9), only ISLD, NH and CDA were significantly changed. ISAD of the right and left side, ISLD of the right and left side, premaxilla deviation angle, nostril height and columella length were changed significantly in bilateral cleft lip and palate (BCLP) cases (n = 10). NAM is a suitable presurgical treatment modality. A positive effect has been seen in UCLP and BCLP infants, as compared with their birth status.
Journal Article
3D morphometric evaluation of the dental arches in children with cleft lip and palate submitted to different surgical techniques
by
Soares, Simone
,
de Carvalho Carrara Cleide Felício
,
de Menezes Márcio
in
Children
,
Cleft lip/palate
,
Dentistry
2022
ObjectivesThis study aimed to compare dimensional alterations of dental arches in children with unilateral complete cleft lip and palate before and after different techniques of primary plastic surgeries.Materials and methodsThe sample was divided into two groups: group 1—cheiloplasty by Millard’s technique and one-stage palatoplasty by von Langenbeck’s technique; group 2—cheiloplasty by Millard’s technique and two-stage palatoplasty: anterior palatoplasty by Hans Pichler’s technique and posterior palatoplasty by Sommerlad’s technique. Dental arches were evaluated before (T1), after the first phase (T2), and 1 year after the second phase (T3) of primary surgeries. Linear measurements and palatal area were assessed. To analyze the method’s error, interclass correlation coefficient was applied. ANOVA (followed by Tukey test), dependent, and independent t-test were used (p < 0.05).ResultsAt T1, the intertuberosity distance was statistically greater in G2 (p = 0.004). At T2, the anterior length of the dental arch was statistically greater in G2 (p = 0.025), while the area of the smaller palatal segment (p = 0.001), cleft area (p = 0.014), and total area (p = 0.002) were statistically smaller in G2. At T3, the intertuberosity distance was statistically greater in G2 (p = 0.017).ConclusionThis study suggests that cheiloplasty and one-stage palatoplasty resulted in smaller growth of maxilla than cheiloplasty and two-stage palatoplasty in the linear measurements (T-T’ and I-CC’) and total area of the dental arches.Clinical relevance.Surgical protocols need to be evaluated to verify their effects aiming at improving the clinical practice of the interdisciplinary team, determining new parameters for the rehabilitation of individuals with cleft lip and palate.
Journal Article
Assessment of symmetry and parental satisfaction after use of customized nasal conformers in unilateral cleft lip repair: a randomized controlled clinical trial
by
Oraby, Mona Samy
,
Osman, Saeeda Mahmoud
,
Khodir, Mahmoud Akram
in
Cleft lip
,
Cleft Lip - surgery
,
Cleft lip repair
2025
Objectives
To evaluate the effectiveness of customized nasal conformers used after unilateral cleft lip repair on nasal symmetry and parental satisfaction.
Materials and methods
Fourteen medically free, non-syndromic children aged 10–24 weeks with unilateral cleft lip were divided into two groups. All patients underwent primary repair using the Fisher technique. Group I received customized nasal conformers fabricated using digital models, while Group II did not. Anthropometric measurements, including nostril height and width, columella deviation angle, and nasolabial angle were used to assess nasal symmetry between both groups. Parental satisfaction was evaluated using the Cleft Evaluation Profile (CEP).
Results
At six months postoperatively, Group I showed no significant difference between cleft and non-cleft sides across all parameters. In contrast, Group II exhibited significant asymmetry in nostril height and width, although no significant difference was observed in the nasolabial angle. CEP scores showed significantly higher satisfaction in fathers for lip, nose, and profile, and in mothers for nose and profile. No significant difference was noted in teeth appearance for either parent group. Intra-examiner reliability was reliable across all parameters.
Conclusions
The use of customized postsurgical nasal conformers in unilateral cleft lip repair was associated with improved symmetry between cleft and non-cleft sides and appeared to reduce relapse, which may have contributed to increased parental satisfaction with the treatment.
Trial registration
Was retrospectively registered at Clinicaltrials.gov on 23/10/2024 (NCT06637488).
Journal Article
Impact of early cleft lip and palate surgery on maxillary growth in 5- and 10-Year-old patients with unilateral cleft lip and palate: a cross-sectional study
by
Koskova, Olga
,
Vokurkova, Jitka
,
Brysova, Alena
in
5YO index
,
Age factors in disease
,
Agreements
2024
Objectives
This study evaluated maxillary growth and dental arch relationships at 5 and 10 years of age in patients with unilateral cleft lip and palate (UCLP) who underwent early cleft lip and palate surgery.
Methods
28 patients with UCLP who underwent cleft lip surgery in neonatal age and cleft palate surgery at average age of 7 months without orthodontic treatment (intervention group) were measured for intercanine and intermolar distances and for dental arch length. These measurements were compared with those of 30 healthy participants in a control group. Dental arch relationships in the intervention group were evaluated by 5-YO index at 5 years and the GOSLON Yardstick score at 10 years of patients’ age.
Results
Patients in the intervention group had significantly shorter mean intercanine distance and arch length than control patients at both 5 and 10 years of age (p<.001 for all). There were no significant differences in intermolar distance at both 5 (
p
= .945) and 10 years (
p
= .105) of patients’ age. The average 5YO index increased from 2.46 to an average GOSLON 10-year score of 2.89 in intervention group.
Conclusion
Intercanine distance and dental arch length of patients with UCLP are significantly reduced at 5 and 10 years after early cleft lip and palate surgeries compared to the healthy population. Dental arch relationships at 5 and 10 years of patients with UCLP show comparable outcomes to those reported by other cleft centers.
Clinical significance
This study evaluates maxillary growth in UCLP patients 5 and 10 years of age who underwent early primary lip and palate surgery.
Journal Article
A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial
by
Chopra, Samiksha
,
Hussain, Syed Altaf
,
Kahlon, Sukhdeep Singh
in
Alveolar Process - surgery
,
Babies
,
Biomedicine
2024
Background
Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment.
Method
The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site.
Discussion
We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe.
Trial registration
ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up.
How to search: (
https://ctri.nic.in/Clinicaltrials/advsearch.php
—use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).
Journal Article