Comparison Between Socket Shield and Conventional Techniques in Immediate Implant Placement.
Comparative Study Between Using Socket Shield And Conventional Techniques In Immediate Implant Placement (A Randomized Clinical Trial)
The goal of this randomized clinical trial is to compare whether immediate implant placement using the socket-shield technique can better preserve bone density, bone level, and peri-implant tissue health compared to conventional immediate implant placement in patients requiring tooth extraction in the maxillary esthetic zone.
This study is conducted in systemically healthy adult patients aged 20-60 years who have non-restorable maxillary anterior teeth indicated for immediate implant placement.
The main questions this study aims to answer are:
Does the socket-shield technique result in better peri-implant bone density and bone level preservation compared to the conventional immediate implant technique?
Does the socket-shield technique lead to improved clinical peri-implant parameters, including probing depth, bleeding on probing, keratinized tissue width, and soft tissue thickness?
participants will be divided into two groups: (both groups will receive immediate implant placement of a tooth requiring extraction in the maxillary esthetic zone.) First group: will recieve immediate implant using conventional technique. second group: will recieve immediate implant using socket shield technique.
Participants will:
- Undergo clinical and radiographic examinations, including cone beam computed tomography (CBCT).
- Receive immediate implant placement using either the conventional technique or the socket-shield technique.
- Be followed up clinically and radiographically for 9 months to assess bone and soft tissue healing.
- Attend regular postoperative and follow-up visits for evaluation of implant stability and peri-implant tissue health.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Omar I Wahedi
- 전화번호: +201064769520
- 이메일: wahdi3031@gmail.com
연구 장소
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Minya, 이집트
- 모병
- Minia University
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연락하다:
- Minia University
- 전화번호: 086 2347768
- 이메일: ddent.office@mu.edu.eg
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged between 20 and 60 years of both genders
- All participants should be systemically healthy, as assessed using the dental modification of the Cornell Medical Index.
- Gingival and periodontal health to be confirmed according to the criteria outlined in the new classification system proposed by Caton et al. (2018).
- Presence of non-restorable teeth due to trauma, complicated crowns or root fractures.
- Presence of extensive destructive caries making the tooth unsalvageable, particularly in esthetic zones.
- Clinical indication for immediate implant placement, especially in cases where minimizing post-extraction bone resorption and soft tissue collapse is critical.
- Availability of adequate interocclusal space to accommodate the necessary prosthetic components without occlusal interference.
Exclusion Criteria:
(for socket-shield technique)
- Pregnant female.
- Patients with parafunctional habits (e.g., bruxism, clenching).
- Smokers.
- Teeth with clinical mobility.
- Teeth with root fractures extending below the alveolar bone level.
- Periodontal ligament space widening.
- Signs of internal or external root resorption.
- Current or previous periodontal disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: GROUP I
Immediate Implant Placement Using Conventional Technique
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Immediate Implant Placement Using Conventional Technique
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실험적: GROUP II
Immediate Implant Placement Using Socket-Shield Technique
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Immediate Implant Placement Using Socket-Shield Technique
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Bone Density Around Immediate Implants.
기간: At baseline of implant placement then after 9 months
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Assessment of bone mineral density using Gray scale values (GSV) derived from Cone Beam Computed Tomography (CBCT) scans. Measurements will be evaluated at the buccal bone adjacent to the retained root fragment (Socket Shield Group) and adjacent to the implant surface (Conventional Immediate Placement Group). The change will be calculated by subtracting the baseline value from the 9-month follow-up value. Unit of Measure: Gray scale values Time Frame: Baseline to 9 months post-implant placement Measure Description: Bone density measured using average gray values extracted from CBCT DICOM files at the buccal aspect of the implant site. Gray scale values reflect the radiographic attenuation/pixel intensity of the surrounding bone. |
At baseline of implant placement then after 9 months
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Change in Marginal Bone Level Around Immediate Implants.
기간: At baseline of implant placement then after 9 months.
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At baseline of implant placement then after 9 months.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Probing Depth (PD)
기간: 3 months, 6 months, and 9 months post-surgery.
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Measurement of the distance from the peri-implant mucosal margin to the bottom of the clinical pocket using a calibrated periodontal probe. Unit of Measure: Millimeters (mm) |
3 months, 6 months, and 9 months post-surgery.
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Modified Gingival Index (MGI)
기간: 3 months, 6 months, and 9 months post-surgery.
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Assessment of the visual signs of inflammation of the peri-implant soft tissues. Scores range from 0 to 4 (0 = Normal, 1 = Mild inflammation, 2 = Mild inflammation with color change, 3 = Moderate inflammation, 4 = Severe inflammation). Unit of Measure: Score on a scale (0-4) |
3 months, 6 months, and 9 months post-surgery.
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Modified Plaque Index (MPI)
기간: 3 months, 6 months, and 9 months post-surgery.
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Assessment of the amount of plaque on the implant/restoration surface. Scores range from 0 to 3 :
Unit of Measure: Score on a scale (0-3) |
3 months, 6 months, and 9 months post-surgery.
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Gingival Thickness (GT)
기간: Baseline, 3 months, 6 months, and 9 months post-surgery.
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Assessment of the thickness of the peri-implant mucosa. This will be measured using a digital caliper or endodontic file with a rubber stopper 2mm apical to the gingival margin. Unit of Measure: Millimeters (mm) |
Baseline, 3 months, 6 months, and 9 months post-surgery.
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Width of Keratinized Tissue (KTW)
기간: Baseline, 3 months, 6 months, and 9 months post-surgery.
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Measured from the gingival margin to the mucogingival junction at the mid-facial aspect of the implant site. Unit of Measure: Millimeters (mm) |
Baseline, 3 months, 6 months, and 9 months post-surgery.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- MU-EC Research No.1187
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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