Do Immediate Digital Workflows Increase Patient Value? (ITI PROM RCT)
2026年6月15日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：PD Dr. Frank Spitznagel, DMD
- 電話番号：+49-211-81-04440
- メール：frank.spitznagel@med.uni-duesseldorf.de
研究場所
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North Rhine-Westphalia
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Düsseldorf、North Rhine-Westphalia、ドイツ、40225
- Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany
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コンタクト：
- PD Dr. Frank Spitznagel, DMD, PhD
- 電話番号：+49-211-81-04440
- メール：frank.spitznagel@med.uni-duesseldorf.de
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主任研究者：
- PD Dr. Frank Spitznagel, DMD
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副調査官：
- Dr. Patrick Klein, DMD
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副調査官：
- Prof. Dr. Petra Gierthmühlen, DMD
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Hong Kong、香港
- The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of Dentistry Prince Philip Dental Hospital
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コンタクト：
- Prof. Melissa Fok, DMD
- 電話番号：+852 2859 0301
- メール：melfok@hku.hk
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主任研究者：
- Prof. Melissa Fok, DMD
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副調査官：
- Prof. George Prof. Pelekos, DMD
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副調査官：
- Dr. Dominic Ho, DMD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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).
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Workflow-Related Patient Experience
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月3日
一次修了 (推定)
2028年10月31日
研究の完了 (推定)
2028年10月31日
試験登録日
最初に提出
2026年6月8日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月18日
QC基準を満たした最後の更新が送信されました
2026年6月15日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2115-2026 (その他の助成金/資金番号：ITI - International Team for Implantology)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。