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Clinical Outcomes of 3D Printed and Milled Complete Dentures

2026年9月15日 更新者：Dentsply Sirona Implants and Consumables

An Open, Single-center, Prospective, Randomized, Two-armed, Interventional, Post-market Clinical Investigation of 3D Printed Complete Dentures and Milled Complete Dentures During a 5-year Follow-up Period

This is a two-armed, single-center clinical study evaluating performance, efficacy and safety of three dimensional (3D) printed complete dentures and milled complete dentures during a 5-year follow-up period. The primary objective of this clinical investigation is to evaluate survival rate, i.e. subjects with survived dentures in both upper and lower jaw, of 3D printed complete dentures and milled complete dentures after 1 year (in each of the groups separately).

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

68

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

研究連絡先のバックアップ

研究場所

  • アメリカ
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27599
        • 募集
        • Adams School of Dentistry
        • コンタクト：

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:

  • Adult aged 18 years or above at time of informed consent.
  • Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation.
  • Subject willing to comply with investigational related procedures and to return for follow-up visits for a period of 5 years.
  • Subject has signed and dated the informed consent form.
  • Subjects in need of complete dentures in maxilla and mandible.
  • Prosthodontic Diagnostic Index (PDI) Completely edentulous classification (Class 1-3).
  • History of edentulism of at least 1 year.

Exclusion Criteria:

  • Known allergy or hypersensitivity to any of the components.
  • Subjects with significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6 ).
  • Known pregnancy at time of enrolment.
  • Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
  • Previous enrolment in the present clinical investigation.
  • Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).

  • PDI Completely edentulous classification (Class 4)

    • Presence of severely atrophied ridge.
    • Presence of severe ridge undercuts.
    • Clinically severe Xerostomia.
    • Absence of hard or soft tissue pathology that precludes denture therapy.
    • Maxillofacial defects.
  • Uncontrolled pathological process in the oral cavity, as judged by the Investigator.
  • Participation in another clinical investigation that may interfere with the present clinical investigation.

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：支持療法
  • 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
実験的：3D printed dentures
3D printed denture bases and 3D printed denture teeth.
デバイス：Lucitone Digital Print

Consisting of the following parts:

  • Lucitone Digital Print 3D Denture Base.
  • Lucitone Digital Interpenetrating Polymer Network (IPN) 3D Premium Tooth.
  • Lucitone Digital Print Denture System Accessories
実験的：Milled dentures
Milled denture bases and denture teeth.
デバイス：Lucitone Digital Fit

Consisting of the following parts:

  • Lucitone Digital Fit Denture Discs.
  • Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.

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
Denture survival rate
時間枠：One year after baseline (baseline = final denture insertion performed within 6-months from day 1)
Restorations still in function after 1 year.
One year after baseline (baseline = final denture insertion performed within 6-months from day 1)

二次結果の測定

結果測定
メジャーの説明
時間枠
Denture survival rate
時間枠：3 and 6 months, and 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Restorations still in function after 3 and 6 months, and 2, 3, 4 and 5 years.
3 and 6 months, and 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture success
時間枠：3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)

A denture will be considered successful if all the following criteria are fulfilled:

Absence of major technical complications.

Absence of major biological complications.

Functional occlusion and mastication, assessed by clinical examination and OHIP-EDENT.

  • Assessed by OHIP-EDENT - Q1 from OHIP: "Have you had difficulty chewing any foods because of problems with your teeth, mouth or dentures?", where score 0-2 would be considered successful (0=never, 1=hardly ever, 2 = occasionally).

Absence of patient reported discomfort, assessed by OHIP-EDENT.

  • Assessed by all questions in Physical pain section of OHIP-EDENT - Q4 "Have you had painful aching in your mouth?", Q5 "Have you found it uncomfortable to eat any foods because of problems with your teeth, mouth or dentures?", Q6 "Have you had sore spots in your mouth?, Q7 "Have you had uncomfortable dentures?", where score 0-1 would be considered successful (0=never and 1=hardly ever).
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture adaptation accuracy
時間枠：At baseline (baseline = final denture insertion performed within 6-months from day 1)
Evaluation of accuracy of 3D printing and milling technology will be made using Geomagic Software at time of final denture insertion. The denture intaglio at insertion will be compared with the final impression as reference scan.
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture retention force
時間枠：3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Retention force of the dentures will be evaluated by applying a dynamometer gauge at the following locations: Post dam, Tuberosities and retromolar pads.
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Technical Complications
時間枠：At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)

Complications will be recorded and assessed as either:

  • Major complications (requiring laboratory intervention to correct - fracture, lab reline, etc.).
  • Minor complications (requiring chairside adjustment - sore spots, occlusal discrepancies, etc.).
At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Biological Complications
時間枠：At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Occurrence of biological complications. Biological complications will be evaluated by recording major and minor biological complications. The evaluation of biological complications will be derived from the adverse event (AE)/adverse device effect (ADE) sections of the Case Report Form.
At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
OHIP-EDENT Questionnaire.
時間枠：3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Quality of Life through Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) Questionnaire completed by participating subjects. OHIP-EDENT contains 19 questions, divided into six domains: Functional limitations, Physical pain, Psychological discomfort, Physical disability, Psychological disability and Handicap. Response categories for all questions: 4 = very often; 3 = fairly often; 2 = occasionally; 1 = hardly ever; 0=never, i.e. lower scores corresponds with higher quality of life.
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture quality assessed via volumetric loss
時間枠：At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Volumetric loss measured in mm3.
At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture quality assessed via maximum vertical loss.
時間枠：At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Maximum vertical loss measured in μm.
At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture quality assessed by discolouration (delta E) at a central incisor (#8).
時間枠：At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Discolouration (intrinsic or interfacial) measured with spectrophotometer. The colour at a central incisor (#8) and the denture just above #8 will be measured.
At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture quality assessed by occlusion (bite position).
時間枠：At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Number of occlusal contacts using articulating paper will be documented.
At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of tooth shape.
時間枠：At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of tooth shape assessed by the following Yes/No question:

Appropriate Tooth Shape to match facial aesthetics?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of tooth size.
時間枠：At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of tooth size assessed by the following Yes/No question:

Appropriate Tooth Size to match facial aesthetics?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of tooth arrangement
時間枠：At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of tooth arrangements assessed by the following Yes/No questions:

  • Overall tooth position, angulation and alignment that appears natural and pleasing?
  • Posterior tooth alignment to maintain adequate buccal corridors?
  • Dental midline aligned in relation to facial midline?
  • Appropriate orientation of occlusal plane in relation to patient's smile line and facial reference lines?
  • Sufficient horizontal overlap?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of tooth colour / colour match
時間枠：At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of tooth colour /colour match assessed by the following Yes/No questions:

  • Appropriate Tooth Shade to suit the naturalness of the patient's skin tone?
  • Appropriate Gingival Shade, translucency and colour characterisation to suit the naturalness of the patient's original gingiva?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of Denture base
時間枠：At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of denture base assessed by the following Yes/No questions:

  • Appropriate tooth to gingival display?
  • Appropriate physical characterisation (contours) of denture base that appears natural and pleasing?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Lip support
時間枠：At baseline (baseline = final denture insertion performed within 6-months from day 1)

Lip support assessed by the following Yes/No questions:

  • Anterior tooth alignment to provide adequate lip support when viewed from the facial profile?
  • Appropriate arch form to allow for natural facial expressions and phonetics?
  • Thickness of denture flange for adequate lip support and facial expressions?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
時間枠：From Day 0 up to completion of the 5-year follow-up visit, on average 5 years and 3 months.
Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.
From Day 0 up to completion of the 5-year follow-up visit, on average 5 years and 3 months.
Patient Satisfaction
時間枠：3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)

Patient satisfaction including aesthetics as evaluated by patient questionnaire including the following questions:

  1. Are you overall satisfied with your dentures?
  2. Are your satisfied with the comfort of your dentures?
  3. Are you satisfied with the aesthetics of your dentures?
  4. Are you satisfied with your ability to speak when wearing your dentures?
  5. Are you satisfied with the fit of your dentures?

Patient satisfaction with dentures will be evaluated using a likert scale, ranging from 0 to 10 for each of above questions. The likert scale representing a spectrum of feelings between extremes with 0= Very unsatisfied and 10= Very satisfied. Patients will rate their assessment by marking a number corresponding to their feelings at the time. A low score represents a high degree of dissatisfaction, and a high score a high degree of satisfaction
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)

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。

スポンサー

Dentsply Sirona Implants and Consumables

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 (実際)

2026年9月11日

一次修了 (推定)

2028年10月30日

研究の完了 (推定)

2032年10月30日

試験登録日

最初に提出

2026年3月30日

QC基準を満たした最初の提出物

2026年5月7日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月17日

QC基準を満たした最後の更新が送信されました

2026年9月15日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • C-LA-24-020

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

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

はい

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。

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