PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Performance and Safety of ON DENT™ PMMA Disc/Block and Resin Products Used in Temporary Restoration Fabrication
This prospective, single-center, interventional post-market clinical follow-up (PMCF) study aims to evaluate the clinical performance and safety of temporary crown and bridge restorations fabricated using CE-marked ON DENT™ restorative materials throughout their functional intraoral clinical duration.
A total of 120 adult patients requiring fixed prosthodontic treatments will be randomly assigned to four independent parallel groups (30 patients per group) based on the specific type of temporary material utilized: Tempo-CAD Monocolor PMMA, Tempo-CAD Monocolor SHT PMMA, Tempo-CAD Multicolor SHT PMMA, or Print On Cyclone Perma liquid resin.
Patients will be monitored closely across 5 clinical visits up to a maximum duration of 6 months to assess prosthodontic survival, success rates, biological adaptations, and patient-reported quality of life outcomes.
調査の概要
状態
募集
詳細な説明
This study is designed as a prospective, single-center, randomized, parallel-group clinical evaluation in Turkey to gather real-world data on PMMA polymer blocks and liquid resins manufactured by ON-DENT Ltd. Sti. Temporary fixed restorations play an essential role in protecting prepared natural teeth or dental implants, maintaining positional stability, and ensuring aesthetic and masticatory functions until the delivery of final definitive prostheses.
Participants meeting all eligibility criteria will be randomized via a balanced computer-generated Python permutation algorithm into four arms:
- Group A: ON DENT™ Tempo-CAD Monocolor PMMA Disc/Block
- Group B: ON DENT™ Tempo-CAD Monocolor SHT PMMA Disc/Block
- Group C: ON DENT™ Tempo-CAD Multicolor SHT PMMA Disc/Block
- Group D: ON DENT™ Print On Cyclone Perma 3D Printer Resin
Clinical and laboratory procedures are rigorously standardized to eliminate confounding variables across all study arms. All provisional restorations will be fabricated using uniform digital dental workflows at a single certified dental laboratory. For Groups A, B, and C, crowns and bridges will be produced via high-precision digital scanning, computer-aided design (CAD) software, and computerized milling units (CAD/CAM). For Group D, restorations will be processed through digital scanning, CAD software, and stereolithographic 3D printing methodologies utilizing digital light processing (DLP) technology. To ensure clinical standardization and minimize inter-operator variability, all clinical interventions, prosthodontic evaluations, and cementation workflows will be performed by prosthodontic investigators adhering to identical operational and clinical protocols, utilizing an identical temporary cement brand.
The evaluative timeline consists of five major operational checkpoints: Baseline (Visit 1: Tooth Preparation & Impression), Visit 2 (Provisional Delivery at days 1-3), Visit 3 (Substructure Framework Try-in at day 8±2), Visit 4 (Aesthetic Try-in at day 12±2), and Visit 5 (Final Definitive Delivery at day 15±2). Longitudinal follow-up evaluations will cover the entire clinical service life of the temporary restorations up to a maximum duration of 6 months, explicitly tracking the period from initial tooth preparation until the formal delivery of the definitive prosthesis. All clinical, biological, and functional prosthodontic outcomes will be verified multi-dimensionally using the internationally recognized Revised World Dental Federation (FDI) Criteria.
研究の種類
介入
入学 (推定)
120
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：Nurten Ozdenler, Sponsor Rep
- 電話番号：+90 (232) 253 2577
- メール：nurten@on-dent.com
研究場所
-
-
-
Izmir、トルコ（Türkiye）、35040
- 募集
- Ege University, Faculty of Dentistry, Department of Prosthodontics
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コンタクト：
- Mine Dundar Comlekoglu, Professor
- 電話番号：+90 (532) 552 74 16
- メール：minedundar@yahoo.com
-
副調査官：
- Ozgur Yasar, MD, Spec.
-
-
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:
- Aged 18 years or older
- Male or female
- Requires 1/2/3-unit prosthetic restoration with temporary crown or bridge
- No active periodontal disease
- No general health condition contraindicated to treatment
- Not legally restricted (no military conscription, incarceration, or other legal restriction)
- Provision of signed informed consent form
Exclusion Criteria:
- Suspected or confirmed pregnancy,
- Temporomandibular joint disorder or limited mouth opening
- Deep subgingival margins (>0.5 mm)
- Non-restorable teeth
- Non-functional teeth (no opposing counterpart /antagonist)
- Probing depth >3 mm
- Pathological tooth mobility
- Unfavorable occlusal relationship or parafunction (bruxism, etc.)
- Active systemic infection or condition/treatment that may impede treatment (radiotherapy, bisphosphonate use, etc.)
- Inadequate oral hygiene or cognitive/physical disorders impairing daily self-care maintenance.
- Uncontrolled alcohol, tobacco, or nicotine product use
- History of allergy or hypersensitivity to PMMA or resin components
- Concurrent participation in another interventional clinical study
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：他の
- 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：MONOCOLOR PMMA
This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from monocolor polymethyl methacrylate (PMMA) discs/blocks.
The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM).
Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria.
Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.
|
A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows.
The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Monocolor PMMA (polymethyl methacrylate) disc/block restorative material via high-precision centralized CAD/CAM milling procedures.
The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.
|
|
実験的：MONOCOLOR SHT PMMA
This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from monocolor super-high translucent (SHT) polymethyl methacrylate (PMMA) discs/blocks.
The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM).
Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria.
Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.
|
A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows.
The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Monocolor SHT (super-high translucent) PMMA disc/block restorative material via high-precision centralized CAD/CAM milling procedures.
The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.
|
|
実験的：MULTICOLOR SHT PMMA
This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from multi-layered (multicolor) super-high translucent (SHT) polymethyl methacrylate (PMMA) discs/blocks.
The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM).
Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria.
Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.
|
A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows.
The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Multicolor SHT (super-high translucent) multi-layered PMMA disc/block restorative material via high-precision centralized CAD/CAM milling procedures.
The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.
|
|
実験的：3D Printer Resin
This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from fluid, light-curable dimethacrylate-based photopolymer resin.
The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured through stereolithographic 3D printing utilizing Digital Light Processing (DLP) technology.
Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria.
Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.
|
A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows.
The provisional prosthesis is manufactured specifically from the ON DENT™ Print On Cyclone Perma fluid, light-curable dimethacrylate-based photopolymer acrylic resin material via centralized stereolithographic 3D printing utilizing DLP (digital light processing) technology.
The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.
|
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 |
|---|---|---|
|
Success Rate of Temporary Fixed Restorations
時間枠：At the final evaluation visit (Visit 5/up to 6 months).
|
The success rate of the provisional restorations will be evaluated using the Revised World Dental Federation (FDI) criteria.
For statistical analysis, the 5-point scale data will be dichotomized into "sufficient" and "insufficient" categories.
Restorations scoring 1 to 3 points-representing clinically excellent/very good (1), clinically good (2), or clinically satisfactory (3) status-will be categorized as "sufficient" (success).
Restorations scoring 4 (clinically insufficient/partially insufficient) or 5 (clinically poor/completely insufficient) points will be categorized as "insufficient" (failure).
The success rate will be calculated as the final percentage of sufficient restorations within each independent arm.
|
At the final evaluation visit (Visit 5/up to 6 months).
|
|
Survival Rate of Temporary Fixed Restorations
時間枠：Throughout follow-up period (up to 6 months).
|
The survival rate of the provisional restorations will be evaluated using the Revised FDI criteria.
The calculation of the survival rate uses the dichotomization of the data into "restoration present including repaired" (scores 1-4) and "not present/failed" (score 5).
Restorations scoring 1 to 4 points-encompassing all clinically sufficient statuses (1-3) and those evaluated as clinically insufficient but retained in function via repair or re-cementation (4)-will be categorized as "restoration present including repaired" (survived).
Restorations scoring 5 points, indicating completely insufficient status or a restoration that is no longer present, will be categorized as "not present/failed".
Cumulative survival probabilities over time will be estimated using the Kaplan-Meier method.
|
Throughout follow-up period (up to 6 months).
|
|
Incidence of Clinical Complications
時間枠：Throughout follow-up period (up to 6 months).
|
The safety and clinical durability profiles of the provisional fixed dental restorations will be evaluated based on the frequency and specific types of technical, mechanical, or biological complications documented during the follow-up period.
Data will be analyzed and reported independently for each study arm as the absolute count (n) and the percentage (%) of restorations experiencing at least one complication, utilizing descriptive and intra-group longitudinal statistics
|
Throughout follow-up period (up to 6 months).
|
|
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
時間枠：Throughout follow-up period (up to 6 months).
|
Safety and tolerability tracking evaluated through the occurrence, severity, and causality-related frequencies of any reported Adverse Events (AE), Serious Adverse Events (SAE), and device deficiencies.
Evaluations are conducted in accordance with the Medical Device Coordination Group (MDCG 2020-10/1) guidelines.
Data will be analyzed independently within each device arm, reporting the absolute number of events and the percentage of participants affected.
|
Throughout follow-up period (up to 6 months).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient-Reported Masticatory Satisfaction
時間枠：Baseline (pre-treatment at Visit 1) and at all subsequent follow-up checkpoints (Visit 2, Visit 3, Visit 4, and Visit 5/up to 6 months).
|
Subjective patient-reported evaluation of satisfaction regarding chewing efficiency and functional comfort.
This parameter will be quantified using a standard 5-point Likert scale, ranging from a score of 1 ("Not satisfied at all") to 5 ("Very satisfied").
Higher summary scores represent superior patient-reported functional comfort.
Statistical analysis will be performed independently within each arm using longitudinal descriptive statistics to monitor changes from baseline.
|
Baseline (pre-treatment at Visit 1) and at all subsequent follow-up checkpoints (Visit 2, Visit 3, Visit 4, and Visit 5/up to 6 months).
|
|
Oral Health-Related Quality of Life (OHRQoL)
時間枠：Baseline (pre-treatment at Visit 1) and at the final follow-up/definitive delivery checkpoint (Visit 5/up to 6 months).
|
Oral health-related quality of life will be measured using the validated Turkish version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
The instrument evaluates 14 items distributed across 7 conceptual subdomains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and social disadvantage).
Each item is scored on a 5-point Likert scale from 0 ("Never") to 4 ("Very often").
Total summary scores range from 0 to 56, where lower overall scores represent better OHRQoL and higher scores indicate a greater negative impact of oral health conditions.
Analysis will track the longitudinal shift within each independent arm.
|
Baseline (pre-treatment at Visit 1) and at the final follow-up/definitive delivery checkpoint (Visit 5/up to 6 months).
|
|
Clinical Evaluation of Masticatory Function (Occlusion Quality)
時間枠：Baseline (pre-treatment at Visit 1) and at all subsequent follow-up checkpoints (Visit 2, Visit 3, Visit 4, and Visit 5/up to 6 months).
|
Objective clinical evaluation of the chewing function through occlusal contact distribution.
The assessment will be performed using extra-thin articulation paper (<10 μm) under light masticatory force in centric relation.
The examining dentist will evaluate whether ideal occlusal contact is established and if forces are evenly distributed across the dental arch (recorded as a binary outcome: "Yes/Acceptable Occlusion" or "No/Unacceptable Occlusion").
Data will be reported as the frequency and percentage of successful occlusal alignment within each independent study arm, tracking longitudinal intra-group changes.
|
Baseline (pre-treatment at Visit 1) and at all subsequent follow-up checkpoints (Visit 2, Visit 3, Visit 4, and Visit 5/up to 6 months).
|
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。
捜査官
- 主任研究者：Mine Dundar Comlekoglu、Ege University, Faculty of Dentistry, Department of Prosthodontics
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)
2025年12月5日
一次修了 (推定)
2027年3月4日
研究の完了 (推定)
2027年7月4日
試験登録日
最初に提出
2026年6月2日
QC基準を満たした最初の提出物
2026年6月2日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月10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7日
最終確認日
2026年5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
- INFO ON DENT GR
- 2025-080 (Turkish Medicines and Medical Devices Agency (TITCK))
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 (IPD) will not be shared publicly due to the strict confidentiality requirements, personal data protection legislation (KVKK Law No. 6698), and commercial intellectual property rights policies of the sponsor.
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
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。