- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ying S. Wang, DDS, MS
- 전화번호: 2114-828-8282
- 이메일: yswang@tamu.edu
연구 연락처 백업
- 이름: Emma Dixon, DDS
- 이메일: emmadixon@tamu.edu
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Graduate Orthodontic Clinic
설명
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.
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Adolescence who completed fixed orthodontic treatment
|
No intervention will be done during the study. It is strictly observational. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Gingival Enlargement (GE) Index Score
기간: 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)
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient reported outcome
기간: 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)
기간: 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)
기간: 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)
기간: Day 0, 1 month, 6 months
|
0 = No plaque.
|
Day 0, 1 month, 6 months
|
|
Gingival Index (Löe & Silness, 1963)
기간: Day 0, 1 month, 6 months
|
0 = Absence of inflammation.
|
Day 0, 1 month, 6 months
|
|
Gingival phenotype (Kan 2010)
기간: 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)
기간: Day 0, 1 month, 6 months
|
measured in mm |
Day 0, 1 month, 6 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .