Bone-borne Palatal Expander With Corticotomy for Cleft Palate Patients
Primary Purpose
Cleft Palate
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Use of bone-borne palatal expander & maxillary osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Palate focused on measuring Cleft palate, transverse discrepancy, palatal expansion, bone-borne
Eligibility Criteria
Inclusion Criteria:
- Patients with non-syndromic cleft palate.
- Patients with constricted maxilla after surgical treatment of cleft palate.
- Patients failed orthodontic expansion.
- Patients age between 8 and 18 years.
Exclusion Criteria:
- Patients with systemic disease or bleeding disorders.
- Patients with syndromic cleft palate.
- Patients failed with tooth borne expansion.
- Patients with fistula in cleft palate
Sites / Locations
- Cairo University
Outcomes
Primary Outcome Measures
Adequate maxillary expansion
Dental casts before treatment & immediately after completion of expansion to determine transverse changes in maxillary arch width measured in millimeter at the following sites:
Intermolar width Intercanine width Interarch width 6
CBCT before operation & immediately after completion of consolidation period (10 weeks). Distances measured on the coronal images in millimeters before treatment & after the end of the consolidation period:
NFW4 & NFW6: Nasal floor width at the area of first premolars & first molars, 5mm above the most inferior part of nasal floor
PBW4 & PBW6 : Palatal bone width at the level of a line connecting palatal root apex of first premolars & first molars
IRD4: distance between palatal root apex of right & left first premolars
IRD6: distance between palatal root apex of right & left first molars
Secondary Outcome Measures
Full Information
NCT ID
NCT03837652
First Posted
February 7, 2019
Last Updated
February 8, 2019
Sponsor
Sarah Ahmed Sameh
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03837652
Brief Title
Bone-borne Palatal Expander With Corticotomy for Cleft Palate Patients
Official Title
Evaluation of Bone-borne Palatal Expander in Conjunction With Maxillary Osteotomy in the Treatment of Cleft Palate Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Ahmed Sameh
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The tooth-borne palatal expander has limitations in the subset of patients with scarred, constricted cleft palate. At times, although posterior expansion is successful, transverse expansion of the anterior palate (near the alveolar cleft) is inadequate.
Will the application of bone borne palatal expander combined with a corticotomy be more effective in the expansion of the constricted maxilla in cleft palate patients?
Detailed Description
Intervention:
Application of bone-borne palatal expander in conjunction with maxillary osteotomy for expansion of constricted maxillae for previously treated cleft palate patients.
o Preoperative Preparations: All data of the patient will be gathered including personal data, medical history, family history, and classification of palatal cleft will be registered;
Laboratory investigations will be conducted (CBC, coagulation profile, weight). -Models from dental impressions are made to make standardized measurements which include:-
IMD: distance between two lingual grooves of two opposing first molars
ICD: distance between cusp tip if two opposing canines
Alveolar cleft width
Total palatal area
The correct distractor module can be measured bone to bone with the fitting models to choose the distractor length.
o General operative procedures
The procedures will be performed under general anesthesia with nasotracheal intubation.
Local anaesthesia with vasoconstriction Epinephrine 1:100:000 will be injected in the palatal mucosa and mucolabial fold.
The palatal incision is done between the premolar and molar or between the premolars.
Maxillary vestibular incision followed by lateral corticotomy.
Placement of distractor plates horizontally and fixing it with self-drilling screws between two roots on each side.
o Postoperative care:
Cephalosporin antibiotic (Ceclor 125mg q12h) for 5 days.
Otrivin nasal drops for 5 days.
Pyrol drops Analgesic-Antipyretic Paracetamol (Acetaminophen )
Patient will be followed up for 10 weeks.
Activation of distractor is started after 1 week of surgery using the patient's key twice daily.
Sample size Based on the previous paper by Carpenter et al. 2014, the expected difference in maximum expansion will be 7.3+/-5.4m. The investigators will need to study 6 patients to be able to reject the null hypothesis that this response difference is zero with probability (power) o.8. The type I error probability associated with this test of this null hypothesis is 0.05. This sample size is to be increased to 8 to compensate for possible losses during follow up. Sample size was calculated using PS: Power and Sample Size software version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA.)
Recruitment Strategy
Patients will be selected from outpatient clinic of Department of Oral and Maxillofacial surgery - Cairo University.
Screening of patients will continue until the target population is achieved.
Identifying and recruiting potential subjects is achieved through patient database.
B) Data collection, management, and analysis
Data collection methods
Plans for assessment and collection of outcome
Amount of bone expansion will be measured by collecting linear measurements from CBCT and dental models.
Patient satisfaction will be measured using patient chart.
Plans to promote participant retention and complete follow-up
Telephone numbers of all patients included the study will be recorded as a part of the written consent.
All patients will be given a phone call at the time of the predetermined follow-up dates.
Data management All data will be entered electronically. Patients' files are to be stored in numerical order and stored in secure and accessible place. All data will be maintained in storage for 1 year after completion of the study.
Statistical methods Data will be analyzed using IBM SPSS advanced statistics (statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Data will be explored for normality using Kolmogrov-Smirnov test and Shapiro-Wilk test. Comparisons between before and after treatment for normality distributed numeric variables will be done using the paired t-test while for non- normally distributed numeric variables will be done by Wilcoxon sign test. A p-value less than or equal to 0.05 will be considered statistically significant.
Outcome:
A suitable statistical test will be used to evaluate palatal expansion.
Methods for any additional analysis:
No additional subgroup analysis.
C) Monitoring
Data monitoring Data monitoring committee is independent from the supplying company of the palatal expander.
Harms Patient will be closely monitored throughout the post operative period and any notices adverse effects will be managed as seen appropriate
Auditing:
Auditing of the study design will be done by the research committee of the Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate
Keywords
Cleft palate, transverse discrepancy, palatal expansion, bone-borne
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Use of bone-borne palatal expander & maxillary osteotomy
Intervention Description
Application of bone-borne palatal expander in conjunction with maxillary osteotomy for expansion of constricted maxillae
Primary Outcome Measure Information:
Title
Adequate maxillary expansion
Description
Dental casts before treatment & immediately after completion of expansion to determine transverse changes in maxillary arch width measured in millimeter at the following sites:
Intermolar width Intercanine width Interarch width 6
CBCT before operation & immediately after completion of consolidation period (10 weeks). Distances measured on the coronal images in millimeters before treatment & after the end of the consolidation period:
NFW4 & NFW6: Nasal floor width at the area of first premolars & first molars, 5mm above the most inferior part of nasal floor
PBW4 & PBW6 : Palatal bone width at the level of a line connecting palatal root apex of first premolars & first molars
IRD4: distance between palatal root apex of right & left first premolars
IRD6: distance between palatal root apex of right & left first molars
Time Frame
10-12 weeks post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with non-syndromic cleft palate.
Patients with constricted maxilla after surgical treatment of cleft palate.
Patients failed orthodontic expansion.
Patients age between 8 and 18 years.
Exclusion Criteria:
Patients with systemic disease or bleeding disorders.
Patients with syndromic cleft palate.
Patients failed with tooth borne expansion.
Patients with fistula in cleft palate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Sameh, BDS
Phone
01001445232
Email
sarahahmed35@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Sameh, BDS
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Sameh, BDS
Phone
01001445232
Email
sarahahmed35@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27683832
Citation
Figueiredo DS, Cardinal L, Bartolomeo FU, Palomo JM, Horta MC, Andrade I Jr, Oliveira DD. Effects of rapid maxillary expansion in cleft patients resulting from the use of two different expanders. Dental Press J Orthod. 2016 Nov-Dec;21(6):82-90. doi: 10.1590/2177-6709.2016-001.aop.
Results Reference
background
PubMed Identifier
15145658
Citation
Marazita ML, Mooney MP. Current concepts in the embryology and genetics of cleft lip and cleft palate. Clin Plast Surg. 2004 Apr;31(2):125-40. doi: 10.1016/S0094-1298(03)00138-X.
Results Reference
background
PubMed Identifier
18718384
Citation
Aziz SR, Tanchyk A. Surgically assisted palatal expansion with a bone-borne self-retaining palatal expander. J Oral Maxillofac Surg. 2008 Sep;66(9):1788-93. doi: 10.1016/j.joms.2008.04.017.
Results Reference
background
PubMed Identifier
17448861
Citation
Gunaseelan R, Cheung LK, Krishnaswamy R, Veerabahu M. Anterior maxillary distraction by tooth-borne palatal distractor. J Oral Maxillofac Surg. 2007 May;65(5):1044-9. doi: 10.1016/j.joms.2005.12.049. No abstract available.
Results Reference
background
PubMed Identifier
24704281
Citation
Zandi M, Miresmaeili A, Heidari A. Short-term skeletal and dental changes following bone-borne versus tooth-borne surgically assisted rapid maxillary expansion: a randomized clinical trial study. J Craniomaxillofac Surg. 2014 Oct;42(7):1190-5. doi: 10.1016/j.jcms.2014.02.007. Epub 2014 Feb 22.
Results Reference
background
PubMed Identifier
25490552
Citation
Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.
Results Reference
background
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Bone-borne Palatal Expander With Corticotomy for Cleft Palate Patients
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