- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03493477
Evaluation of Gingival Biotypes of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations
3. april 2018 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
120
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 30 år (Voksen)
Tar imot friske frivillige
N/A
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Correlation between gingival biotypes and abnormal sagittal skeletal jaw relations.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Correlation between width of keratinized gingiva in the anterior region and abnormal sagittal skeletal jaw relation
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. mai 2018
Primær fullføring (Forventet)
30. oktober 2018
Studiet fullført (Forventet)
30. oktober 2018
Datoer for studieregistrering
Først innsendt
20. mars 2018
Først innsendt som oppfylte QC-kriteriene
3. april 2018
Først lagt ut (Faktiske)
10. april 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CEBD-CU-2018-03-20
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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