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

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:

  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

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.

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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