- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07936721
Gingival Enlargement Post-orthodontic Treatment
Resolution of Orthodontic Treatment-associated Gingival Enlargement: A Prospective Longitudinal Study
The goal of this observational study is to evaluate spontaneous resolution of gingival enlargement which occurred during fixed orthodontic treatment.
Participants who completed orthodontic therapy will be recruited for the study, and morphological changes and related factors will be assessed.
Also online survey will be used to assess patient reported outcome regarding their gingival appearance.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Ying S. Wang, DDS, MS
- Telefonnummer: 2114-828-8282
- E-mail: yswang@tamu.edu
Undersøgelse Kontakt Backup
- Navn: Emma Dixon, DDS
- E-mail: emmadixon@tamu.edu
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Graduate Orthodontic Clinic
Beskrivelse
Inclusion Criteria:
- Modified Seymour Gingival Encroachment index ≥30% in the labial anterior sextants at the time the removal of fixed orthodontic appliances.
- Age 11 to 19 at the time the fixed orthodontic appliances were first placed.
- On fixed orthodontic appliances for a minimum of 18 months.
Exclusion Criteria:
b. Exclusion criteria
-
Active periodontitis, defined by the presence of clinical attachment loss (CAL) on any of the 12 anterior teeth at the time of orthodontic bracket debonding
-
Does not have/does not use a smartphone (FOR QUALTRICS)
-
Pregnant patients
-
History of periodontal surgery
-
Patients not able to give consent due to intellectual disabilities
-
Patients with medication which can induce GE (e.g. calcium channel blockers, anticonvulsants/phenytoin, Ciclosporin)
-
Subjects diagnosed with conditions which can present with GE (e.g. leukemia, vitamin C deficiency, plasma cell gingivitis, soft tissue pathology, hereditary gingival fibromatosis)
-
Patients with prominent defective restorations
c. Exit criteria
-
Patients developing conditions that result in them meeting any of the above exclusion criteria (e.g., starting a medication that is known to affect the gingiva).
-
Patients requiring surgical periodontal therapy or other urgent treatment on the anterior sextants, at any time point during the study.
-
Patients unable or unwilling to continue in the study.
-
Patients missing the initial (3-7 weeks) postoperative visit.
-
Patients who fail to complete the questionnaire at the applicable visit.
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Adolescence who completed fixed orthodontic treatment
|
No intervention will be done during the study. It is strictly observational. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Gingival Enlargement (GE) Index Score
Tidsramme: Day 0, 1 month, 6 months.
|
Enlargement of bucco-lingual direction scale (Seymour 1985), Extent of encroachment scale (Ellis 2021) |
Day 0, 1 month, 6 months.
|
|
Volumetric Changes in Buccal Gingival Tissue (m^3)
Tidsramme: Day 0, 1 month, 6 months.
|
Gingival volumetric changes in the anterior area will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change. |
Day 0, 1 month, 6 months.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient reported outcome
Tidsramme: Day 0, 1 month, 6 months
|
Patients will answer survey questions regarding their gingival appearance. |
Day 0, 1 month, 6 months
|
|
Changes in height of buccal papilla (mm)
Tidsramme: Day 0, 1 month, 6 months
|
Changes in height of buccal papilla will be calculated in mm |
Day 0, 1 month, 6 months
|
|
Periodontal probing depth (PPD)
Tidsramme: Day 0, 1 month, 6 months
|
PPD will be assessed using periodontal probe (mm) |
Day 0, 1 month, 6 months
|
|
Plaque Index (Silness & Löe, 1964)
Tidsramme: Day 0, 1 month, 6 months
|
0 = No plaque.
|
Day 0, 1 month, 6 months
|
|
Gingival Index (Löe & Silness, 1963)
Tidsramme: Day 0, 1 month, 6 months
|
0 = Absence of inflammation.
|
Day 0, 1 month, 6 months
|
|
Gingival phenotype (Kan 2010)
Tidsramme: Day 0, 1 month, 6 months
|
Outline of periodontal probe is visible = Thin Outline of periodontal probe is not visible = Thick |
Day 0, 1 month, 6 months
|
|
Crown width (CW)
Tidsramme: Day 0, 1 month, 6 months
|
measured in mm |
Day 0, 1 month, 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Zachrisson BU, Zachrisson S. Gingival condition associated with partial orthodontic treatment. Acta Odontol Scand. 1972 Mar;30(1):127-36. doi: 10.3109/00016357209004597. No abstract available.
- Pinto AS, Alves LS, Zenkner JEDA, Zanatta FB, Maltz M. Gingival enlargement in orthodontic patients: Effect of treatment duration. Am J Orthod Dentofacial Orthop. 2017 Oct;152(4):477-482. doi: 10.1016/j.ajodo.2016.10.042.
- Kouraki E, Bissada NF, Palomo JM, Ficara AJ. Gingival enlargement and resolution during and after orthodontic treatment. N Y State Dent J. 2005 Jun-Jul;71(4):34-7.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY2026-0545
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .