Bone-borne Palatal Expander With Corticotomy for Cleft Palate Patients

February 8, 2019 updated by: Sarah Ahmed Sameh

Evaluation of Bone-borne Palatal Expander in Conjunction With Maxillary Osteotomy in the Treatment of Cleft Palate Patients

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

    1. Plans for assessment and collection of outcome

      1. Amount of bone expansion will be measured by collecting linear measurements from CBCT and dental models.
      2. Patient satisfaction will be measured using patient chart.

    2. Plans to promote participant retention and complete follow-up

      1. Telephone numbers of all patients included the study will be recorded as a part of the written consent.
      2. 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.

    1. Outcome:

      A suitable statistical test will be used to evaluate palatal expansion.

    2. 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.

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequate maxillary expansion
Time Frame: 10-12 weeks post operatively

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
10-12 weeks post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarah Ahmed Sameh

Collaborators

Cairo University

Investigators

  • Principal Investigator: Sarah Sameh, BDS, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SarahSamehMsc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cleft Palate

Clinical Trials on Use of bone-borne palatal expander & maxillary osteotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe