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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03493477
Other study ID # CEBD-CU-2018-03-20
Secondary ID
Status Not yet recruiting
Phase
First received March 20, 2018
Last updated April 3, 2018
Start date May 1, 2018
Est. completion date October 30, 2018

Study information

Verified date April 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date October 30, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between gingival biotypes and abnormal sagittal skeletal jaw relations. 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 Correlation between width of keratinized gingiva in the anterior region and abnormal sagittal skeletal jaw relation 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
Secondary Correlation between gingival biotypes and abnormal vertical skeletal jaw relations. 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
Secondary Correlation between width of keratinized gingiva and abnormal vertical skeletal jaw relations. 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