Do Immediate Digital Workflows Increase Patient Value? (ITI PROM RCT)
2026년 6월 15일 업데이트: Heinrich-Heine University, Duesseldorf
Do Immediate Digital Workflows Increase Patient Value? A Patient-Reported Outcome Measure-Based Randomized Controlled Trial Comparing Immediate Versus Delayed Digital Posterior Implant Workflows
This two-center randomized controlled trial will evaluate whether an immediate digital posterior implant workflow provides greater patient-defined value than a delayed digital workflow in adults requiring single posterior implant rehabilitation.
Participants will be randomized 1:1 to immediate implant placement at the time of tooth extraction or to delayed implant placement after approximately 16 weeks of healing following extraction and ridge preservation as indicated.
The primary endpoint is oral health-related quality of life assessed longitudinally using the OHIP-14 questionnaire and analyzed as the model-based mean score averaged across the active treatment phase from baseline through definitive crown delivery.
Secondary outcomes include workflow-related patient experience, chairside time, number of visits, postoperative pain, buccal contour changes based on intraoral scan-derived volumetric analysis, radiographic marginal bone level changes, implant survival, clinical peri-implant parameters, technical complications, esthetic outcomes, accuracy of guided implant placement, and clinician-reported workflow outcomes.
연구 개요
상태
아직 모집하지 않음
상세 설명
Digital implant workflows enable guided surgery, intraoral scanning, and standardized restorative components, and may reduce treatment burden while supporting efficient, patient-centered care. In posterior single-tooth implant rehabilitation, immediate and delayed placement protocols have been extensively evaluated from a biological perspective, but evidence on patient-reported oral health-related quality of life and workflow efficiency remains limited.
The study compares two standardized digital posterior implant rehabilitation pathways that differ in implant placement timing: immediate placement (Type 1C) versus delayed placement (Type 4B). Participants requiring extraction and single implant therapy in posterior premolar or molar sites will be enrolled at two geographically distinct centers. The immediate workflow combines atraumatic extraction and guided implant placement in one surgical session. The delayed workflow includes extraction and ridge preservation as indicated, followed by implant placement after approximately 16 weeks of healing. Both groups will receive guided implant placement with Straumann BLC implants and a screw-retained monolithic zirconia crown according to the protocol.
The primary objective is to compare the overall treatment-related impact on oral health-related quality of life during the active treatment phase using OHIP-14. Key secondary objectives are to compare workflow-related patient experience, objective workflow efficiency, and peri-implant soft tissue contour changes, while monitoring clinical, radiographic, esthetic, implant-related, and prosthetic safety outcomes.
연구 유형
중재적
등록 (추정된)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: PD Dr. Frank Spitznagel, DMD
- 전화번호: +49-211-81-04440
- 이메일: frank.spitznagel@med.uni-duesseldorf.de
연구 장소
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, 독일, 40225
- Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany
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연락하다:
- PD Dr. Frank Spitznagel, DMD, PhD
- 전화번호: +49-211-81-04440
- 이메일: frank.spitznagel@med.uni-duesseldorf.de
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수석 연구원:
- PD Dr. Frank Spitznagel, DMD
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부수사관:
- Dr. Patrick Klein, DMD
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부수사관:
- Prof. Dr. Petra Gierthmühlen, DMD
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Hong Kong, 홍콩
- The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of Dentistry Prince Philip Dental Hospital
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연락하다:
- Prof. Melissa Fok, DMD
- 전화번호: +852 2859 0301
- 이메일: melfok@hku.hk
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수석 연구원:
- Prof. Melissa Fok, DMD
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부수사관:
- Prof. George Prof. Pelekos, DMD
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부수사관:
- Dr. Dominic Ho, DMD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adults aged 18 years or older.
- Indication for single implant therapy in a posterior premolar or molar extraction site.
- Good oral hygiene with FMPS ≤20%.
- Controlled periodontitis according to protocol definition.
- At least one natural tooth adjacent to the implant site and presence of an antagonist tooth.
- Ability to comply with study procedures and provide written informed consent.
- Adequate bone volume for immediate or delayed placement.
- Extraction site suitable for centrally positioned, prosthetically driven implant placement using straight prosthetic components.
- Ability to achieve 3-4 mm circumferential implant engagement in native bone along the planned implant axis while maintaining safety distance from vital structures.
- For molar sites, septal bone classified as Smith & Tarnow Type A or Type B, including cases requiring closed sinus floor elevation.
- Post-extraction socket presenting as a contained or partially contained defect with at least three relatively intact socket walls and no individual socket wall vertical defect >5 mm.
- No facial soft-tissue dehiscence or mucogingival defect associated with buccal bone dehiscence.
Exclusion Criteria:
• Known or suspected poor compliance, alcohol abuse, or substance abuse.
- Systemic or local contraindications to implant surgery.
- History of head/neck radiotherapy or recent malignancy within 5 years.
- Use of medications affecting bone metabolism.
- Bisphosphonate use within the past 5 years.
- Uncontrolled periodontal disease.
- Heavy smoking (>10 cigarettes/day).
- Pregnancy or lactation.
- Teeth with periapical lesions >5 mm in greatest diameter, or sockets demonstrating a large cortical perforation >5 mm in greatest dimension on CBCT.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Immediate Digital Workflow / Immediate Implant Placement (Type 1C)
Atraumatic tooth extraction and guided implant placement during the same surgical session.
Socket management follows the standardized protocol according to defect morphology.
Implants are sealed without functional loading and restored with a definitive screw-retained monolithic zirconia crown after healing.
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Participants allocated to the immediate digital workflow will undergo atraumatic extraction of a non-restorable posterior tooth followed by immediate implant placement during the same surgical session.
Implant placement will be performed using a prosthetically driven digital workflow with static guided surgery.
Socket management and sealing of the extraction socket will be performed according to the standardized study protocol and local standard of care.
Definitive prosthetic restoration will be delivered after the planned healing period.
다른 이름들:
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활성 비교기: Delayed Digital Workflow / Delayed Implant Placement (Type 4B)
Tooth extraction with alveolar ridge preservation as required.
Implant placement is performed after approximately 16 weeks of healing using the same surgical and prosthetic protocol.
Definitive restoration is delivered after healing following implant placement.
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Participants allocated to the delayed digital workflow will undergo atraumatic extraction of a non-restorable posterior tooth followed by alveolar ridge preservation as indicated according to the standardized study protocol and local standard of care.
Implant placement will be performed after approximately 16 weeks of healing using a prosthetically driven digital workflow with static guided surgery.
Definitive prosthetic restoration will be delivered after the planned healing period.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Oral health-related quality of life (OHIP) assessed with OHIP-14 Questionnaire: model-based mean OHIP-14 score averaged across the active treatment phase (0-4 months).
기간: Baseline / enrollment (0 months), 7 days after surgical intervention(s), and definitive crown delivery (approximately 4 months); approximately baseline (0 months) through 4-6 months depending on allocation.
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The primary estimand is the between-group difference in model-based least-squares mean OHIP-14 scores (0-4) averaged across the active treatment phase.
Lower OHIP-14 scores indicate lower treatment-related impact / better oral health-related quality of life.
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Baseline / enrollment (0 months), 7 days after surgical intervention(s), and definitive crown delivery (approximately 4 months); approximately baseline (0 months) through 4-6 months depending on allocation.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Workflow-Related Patient Experience
기간: Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
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Overall treatment experience assessed using a Visual Analogue Scale (VAS 0-100) at crown delivery and at 12-months follow-up.
Higher scores indicate greater perceived treatment experience and perceived value of the treatment pathway.
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Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
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Workflow Efficiency
기간: Visit 1-4 (0 months - up to 4-6 months).
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Chairside time (in minutes) per visit and cumulative chairside time (in minutes) from enrollment through crown delivery (Visit 1-4); number of visits and unplanned interventions (measured in time per minutes).
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Visit 1-4 (0 months - up to 4-6 months).
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Buccal Contour Changes
기간: Visit 1 (Baseline), Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Volumetric region-of-interest shrinkage / contour change derived from serial intraoral scans at protocol-defined visits through from baseline till 12 months after loading
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Visit 1 (Baseline), Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Radiographic Outcomes
기간: Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Marginal bone level changes at implant placement, loading, +6 months, and +12 months post loading (measured in mm); proportion of implants with >1 mm or >2 mm marginal bone loss.
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Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Clinical Soft Tissue Outcomes 1
기간: Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Mid-buccal mucosal level (in mm), keratinized mucosa width (in mm), probing pocket depth (in mm), recession/dehiscence (in mm)
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Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Clinical Soft Tissue Outcome 2
기간: Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Bleeding on probing (in % number of bleeding surfaces/total number of surfaces), Plaque index (in % number of bleeding surfaces/total number of surfaces)
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Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Implant/prosthetic outcomes
기간: Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Implant survival at 6 and 12 months post-loading; technical complications; prosthetic success according to modified United States Public Health (USPHS) criteria.
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Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Pink and White Esthetics
기간: Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Pink Esthetic Score/ White Esthetic Score (PES/WES); The PES and WES scores allow an objective evaluation of the aesthetics of implant supported single crowns and adjacent soft tissues based on five parameters: PES:
WES:
Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. Hence, the highest possible PES and WES score is 10 each, whereas the highest possible combined PES/WES score is 20 |
Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Clinician-reported outcomes
기간: Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Procedural difficulty and workflow perception assessed using a numeric rating scale (NRS, 0-10) at extraction and implant placement (0 = extremely easy, 10 = extremely difficult)
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Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Implant Accuracy
기간: Visit 3 (+0-4 months)
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Implant Placement Accuracy.
Planned versus actual implant position including angulation (in degrees), platform deviation (in mm), and apex deviation (in mm).
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Visit 3 (+0-4 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 3일
기본 완료 (추정된)
2028년 10월 31일
연구 완료 (추정된)
2028년 10월 31일
연구 등록 날짜
최초 제출
2026년 6월 8일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2115-2026 (기타 보조금/기금 번호: ITI - International Team for Implantology)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be made publicly available due to data protection and ethical restrictions.
Aggregated study results will be disseminated through peer-reviewed publication.
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아니
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. .
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