- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04219436
두 가지 다른 봉합 기법이 자유 치은 변연 안정성에 미치는 영향
거미스마일 치료를 위한 심미치관연장술 후 2가지 다른 봉합술이 자유치은변연 안정성에 미치는 영향(무작위임상시험)
Gummy smile is one of the major esthetic problems nowadays; it is due to several causes that either dental or skeletal. Etiology of the gummy smile is altered passive eruption, vertical maxillary excess, different gingival enlargement conditions, deficient maxillary lip length and excessive maxillary lip mobility, dento alveolar extrusion, combination of all these factors.
Altered passive eruption is considered to be one of the most major causes, it is classified into two types according to the location of the mucogingival junction with respect to the bone crest and each type has two subtypes . Esthetic crown lengthening is the treatment of choice for subtype B in both types as bone removal is mandatory to create a space for the biological width.
Most of the studies stated that there is some degree of relapse of the gingival tissues after the procedures in the follow ups, that relapse was related to the biotype of the gingival tissues, the flap placement close or far from the bone can be correlated to the suturing technique used for closure of the tissues.
In the investigator's study comparing of two different suturing technique was done to evaluated their effect on gingival tissue relapse, 30 patients (26 females and 4 males) were divided between 2 groups each group consisted of 15 patients. In the first group vertical mattress suturing technique was done in the secondperiosteal vertical suturing technique was.
Evaluation of the tissue relapse was done through the assessment of the amount of the attached gingival tissues level of gingival margin and marginal tissue contour before and after the surgery.
The results of the study showed that tissue relapse was more in the periosteal suturing technique group that was related to the pressure on the tissues due to the fixation of the suture at the periostium, the papillary tissue also showed more inflammation in the follow up period prior to suture removal. The figure of eight group showed less relapse and tissue inflammation as it prevents flap edge overlap and is tension free therefore better blood supply to the tissue.
Patients were generally satisfied post-surgical with their smile, gingival tissue visibility and teeth dimensions inspite of the relapse but it was better than prior to surgery. Also they would recommend it to other patients complaining from the same problem.
연구 개요
상태
상세 설명
Thirty patients (26 females, 4 males), who were candidates for esthetic crown lengthening, participated in this prospective clinical trial.
Group I (15 patients) (vertical mattress suturing technique) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then External vertical mattress suture was done (periosteal suture).
Group II (15 patients) (periosteal vertical suturing technique) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then periosteal vertical suture was done
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Cairo, 이집트
- Faculty of Dentistry Ain Shams University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients complaining from gummy smile (altered passive eruption)
- Bone level is 2 mm or less from the cemento enamel junction
- Teeth included were free from any periodontal destruction
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program
Exclusion Criteria:
- Presence of systemic diseases which could influence the outcome of the therapy (American society of anesthesiologists I, ASA I).
- Patient suffering from periodontitis stage 4 grade c.
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant females and lactating females. .
- Vulnerable groups of patients (handicapped, mentally retarded, prisoners).
- Restored teeth.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: vertical mattress suturing technique
vertical mattress suturing technique is done to close the flap |
vertical mattress suturing technique used for flap closure after esthetic crown lengthening |
|
활성 비교기: periosteal vertical suturing technique
periosteal vertical suturing technique is done to close the flap |
figure of eight suturing technique used for flap closure after esthetic crown lengthening |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
evaluation of the marginal soft tissue levels rebound
기간: 6 months
|
determination of soft tissue rebound: is measured as the difference between (the level of free gingival margin after suturing) and (the level of the free gingival margin 6 months post surgical) both measured from fixed reference point on the stent to the free gingival margin |
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Supracrestal gingival tissue
기간: 6 months
|
the difference between the bone level and the free gingival margin (measured from a fixed reference point on the stent) |
6 months
|
|
Patient satisfaction
기간: at 6 months post surgical
|
questionnaire (After surgery)
|
at 6 months post surgical
|
공동 작업자 및 조사자
수사관
- 연구 책임자: ahmed gamal, professor, faculty of dentistry ain shams university
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- PER16-35M
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
when the study is done the results will be published with the protocol
IPD 공유 기간
the data will be available starting next month and for 1 year
IPD 공유 액세스 기준
the keywords esthetic crown lengthening, suturing techniques in dentistry
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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