Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Esthetic Outcomes and Digital Soft Tissue Assessment of Customized Versus Stock Healing Abutments for Immediate Implants in the Maxillary Esthetic Zone: A Pilot Randomized Controlled Trial
The aim of this study is to compare customized and stock healing abutments for peri-implant soft tissue changes after immediate implant placement in the maxillary esthetic zone, and to assess the feasibility of a full-scale trial.
연구 개요
상태
정황
상세 설명
Preservation of the peri-implant soft tissue contour and papillae after immediate implant placement is essential for a predictable esthetic result. If customized healing abutments provide better soft tissue outcomes than stock abutments, they could be recommended as a routine step in immediate implant placement in the esthetic zone. Because high-quality comparative evidence is lacking, the present pilot randomized trial was designed to compare the peri-implant soft tissue changes (Pink Esthetic Score at 6 months) around customized versus stock healing abutments, and to provide the feasibility data (recruitment, retention, variability of outcomes) needed to calculate the sample size of a full-scale trial.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Good general health (ASA I or II).
- Adult patients above 18 years of age.
- Males or females.
- Good oral hygiene and compliance with follow-up visits.
- Willing to sign the informed consent.
- Non-restorable (hopeless) tooth in the maxillary esthetic zone (canine to canine).
- Intact facial bone wall of the socket after extraction.
- Sufficient bone apical and palatal to the socket to achieve primary implant stability (≥ 35 Ncm).
- Presence of adjacent and opposing natural teeth.
- Healthy periodontium around adjacent teeth.
Exclusion Criteria:
- Participants with uncontrolled systemic illness.
- Pregnant or lactating females.
- Smokers.
- Concomitant participation in another study.
- Heavy bruxism habits.
- History of radiotherapy to the head and neck region or bisphosphonate therapy.
- Patients who refuse to participate.
- Acute infection or abscess at the site.
- Facial bone wall dehiscence or defect.
- Insufficient bone for primary stability.
- Active periodontal disease.
- Previous bone augmentation or implant at the same site.
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 |
|---|---|
|
실험적: Immediate implant placement with a customized healing abutment
A customized healing abutment replicating the emergence profile of the extracted tooth will be fabricated chairside using resin composite on a titanium abutment / digitally designed and milled and connected to the implant at the same surgical visit. Its design will be based on the cervical cross-section of the extracted tooth. |
Immediate implant placement with a customized healing abutment |
|
활성 비교기: Immediate implant placement with a prefabricated (stock) healing abutment.
• A prefabricated healing abutment will be selected and connected to the implant at the same surgical visit, with the screw torqued according to the manufacturer's instructions. |
Immediate implant placement with a prefabricated (stock) healing abutment. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pink Esthetic Score (PES)
기간: 6 months
|
PES criteria scoring (0-14) |
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Extended Pink Esthetic Score (E-PES)
기간: 6 months
|
E-PES criteria Scoring (0-18) |
6 months
|
|
Probing depth (PD)
기간: 6 months
|
by peridontal probe in millimeters |
6 months
|
|
Buccal soft tissue contour
기간: 6 months
|
Intraoral scan / stone cast superimposition in millimeters |
6 months
|
|
Keratinized mucosa width (KMW)
기간: 6 months
|
Periodontal probe |
6 months
|
|
Marginal bone level (MBL)
기간: 6 months
|
CBCT / periapical radiograph |
6 months
|
|
Digital Assesment of Buccal Mucosa
기간: 6 months
|
digital scanner |
6 months
|
|
Patient Satisfaction for Esthetics
기간: 6 months
|
binary questionnaire (yes/No) |
6 months
|
공동 작업자 및 조사자
스폰서
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. .