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Evaluation of Gingival Biotypes of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations

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ClinicalTrials.gov Identifier: NCT03493477
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed magdy Mohamed Sabrah, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment
Abnormal Jaw Relations Other: exposure will be abnormal skeletal jaw relations

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Gingival Biotypes and Width of Keratinized Gingiva of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations: A Cross-sectional Study
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2018

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
Other: exposure will be abnormal skeletal jaw relations
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
Other: exposure will be abnormal skeletal jaw relations
Class II skeletal jaw relation or class III skeletal jaw relation based on lateral cephalometric radiograph




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 )

  2. 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 )

  3. 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 )



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes 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
Criteria

Inclusion Criteria:

  1. Adult patients having an age range of 18 -30 years.
  2. Adults with skeletal Class II and Class III jaw relation
  3. Fair oral hygiene with absence of any active periodontal disease.
  4. Patients with full permanent dentition (with the exception of third molars) with acceptable alignment of teeth.
  5. Absence of systemic disease (medically free patients).

Exclusion Criteria:

  1. Patients with extensive restorations on the anterior teeth.
  2. Subjects taking medication affecting the periodontal tissues
  3. History of previous periodontal surgery or orthodontic treatment.
  4. Pregnant or lactating female patients
  5. Syndromic patients

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Responsible Party: Ahmed magdy Mohamed Sabrah, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03493477     History of Changes
Other Study ID Numbers: CEBD-CU-2018-03-20
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No