- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03493477
Evaluation of Gingival Biotypes of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations
April 3, 2018 updated by: Ahmed magdy Mohamed Sabrah, Cairo University
Evaluation of Gingival Biotypes and Width of Keratinized Gingiva of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations: A Cross-sectional Study
The aim of this study is to evaluate gingival biotypes and width of keratinized gingiva in the anterior region of adults with abnormal skeletal jaw relations.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study will include consecutive adult patients seeking orthodontic treatment with skeletal Class II and Class III jaw relations based on clinical and cephalometric values.
Each group will be further divided according to their vertical skeletal pattern.
Gingival biotype will be determined -using the probe transparency method- into either thick or thin biotype for all anterior teeth in both jaws.
Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm.
Statistical analysis will be applied to see the correlation between gingival biotypes , width of keratinized gingiva , and abnormal skeletal jaw relations.
Study Type
Observational
Enrollment (Anticipated)
120
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
18 years to 30 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients attending the orthodontic clinic in the orthodontic department, Faculty of Dentistry, Cairo University , who have either skeletal class II or class III maxillo-mandibular jaw relations
Description
Inclusion Criteria:
- Adult patients having an age range of 18 -30 years.
- Adults with skeletal Class II and Class III jaw relation
- Fair oral hygiene with absence of any active periodontal disease.
- Patients with full permanent dentition (with the exception of third molars) with acceptable alignment of teeth.
- Absence of systemic disease (medically free patients).
Exclusion Criteria:
- Patients with extensive restorations on the anterior teeth.
- Subjects taking medication affecting the periodontal tissues
- History of previous periodontal surgery or orthodontic treatment.
- Pregnant or lactating female patients
- Syndromic patients
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Skeletal Class II Group
From the lateral cephalometric radiograph , Steiner analysis (ANB angle should be higher than mean value, mean value 3 ±2), Witt's appraisal should be higher than mean value (mean value zero), and McNamara analysis (A-B diff NV should be higher than mean value, mean value 4±2).At least two of the three mentioned analyses should verify skeletal class II relation
|
Class II skeletal jaw relation or class III skeletal jaw relation based on lateral cephalometric radiograph
|
Skeletal Class III Group
From the lateral cephalometric radiograph , Steiner analysis (ANB angle should be lower than mean value, mean value 3 ±2), Witt's appraisal should be lower than mean value (mean value zero), and McNamara analysis (A-B diff NV should be lower than mean value, mean value 4±2).At least two of the three mentioned analyses should verify skeletal class III relation
|
Class II skeletal jaw relation or class III skeletal jaw relation based on lateral cephalometric radiograph
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between gingival biotypes and abnormal sagittal skeletal jaw relations.
Time Frame: 6 months
|
Gingival biotype will be determined using the probe transparency method, in which probing is done in the sulcus at the mid facial aspect of maxillary and mandibular incisors and canines by a periodontal probe.
Gingival thickness will be classified as thin when the underlying periodontal probe outline can be seen through the gingiva; otherwise, it will be considered thick.
Results of the twelve anterior teeth will be recorded for each patient in a tabulated form.
Statistical Analysis will be done to detect the correlation between gingival biotypes (Thick or thin ) and abnormal sagittal skeletal jaw relation ( skeletal class II or skeletal class III 9
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between width of keratinized gingiva in the anterior region and abnormal sagittal skeletal jaw relation
Time Frame: 6 months
|
Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm.
Statistical analysis will be done to detect the correlation between the width of keratinized gingiva and abnormal sagittal jaw relations (skeletal class II or skeletal class III )
|
6 months
|
Correlation between gingival biotypes and abnormal vertical skeletal jaw relations.
Time Frame: 6 months
|
will be determined using the probe transparency method, in which probing is done in the sulcus at the mid facial aspect of maxillary and mandibular incisors and canines by a periodontal probe.
Gingival thickness will be classified as thin when the underlying periodontal probe outline can be seen through the gingiva; otherwise, it will be considered thick.
Results of the twelve anterior teeth will be recorded for each patient in a tabulated form.Statistical analysis will be done to detect the correlation between the gingival biotype ( thick or thin ) and abnormal vertical skeletal jaw relations ( long face or short face )
|
6 months
|
Correlation between width of keratinized gingiva and abnormal vertical skeletal jaw relations.
Time Frame: 6 months
|
Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm .Statistical analysis will be done to detect the correlation between the width of keratinized gingiva and abnormal vertical skeletal jaw relations ( long face or short face )
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2018
Primary Completion (Anticipated)
October 30, 2018
Study Completion (Anticipated)
October 30, 2018
Study Registration Dates
First Submitted
March 20, 2018
First Submitted That Met QC Criteria
April 3, 2018
First Posted (Actual)
April 10, 2018
Study Record Updates
Last Update Posted (Actual)
April 10, 2018
Last Update Submitted That Met QC Criteria
April 3, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CEBD-CU-2018-03-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.
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