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Набор по приглашению NCT07160660

Patients' Satisfaction and Clinical Investigation of Removable Partial Denture Anchorage With Extracoronal Adhesive Attachments in Comparison With Clasp-retained Partial Dentures

Наблюдательное Extracoronal Adhesive Attachment Clasp-retained Partial Dentures Patients Satisfaction With Removable Dental Prostheses

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Patients' satisfaction and clinical investigation of removable partial denture anchorage with extracoronal adhesive attachments, Patients' satisfaction and clinical investigation of removable partial denture anchorage with conventional clasps.
Кому может быть актуально
Состояния в реестре: Extracoronal Adhesive Attachment, Clasp-retained Partial Dentures, Patients Satisfaction With Removable Dental Prostheses. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Removable partial dentures (RPD) are a well-established treatment option for the prosthetic rehabilitation of partially edentulous patients. They are retained at the remaining natural teeth by clasps to provide functional stability. As an alternative to clasps extacoronal adhesive attachments are fixed to the abutment teeth using adhesive cementation techniques. These adhesive attachments improve retention and stability of the prostheses and are indicated when the patient requires a non-visible retention element and healthy coronal tooth structure is available as a prerequisite. In clinical practice, extracoronal adhesive attachments offer a minimally invasive and aesthetic anchoring alternative of removable dental prostheses associated with higher costs compared to a common clasp retention. As a result, adhesive attachments are relatively rarely used and are technically sensitive both in the clinical realisation and in terms of the dental technology. Hence, limited scientific data are available regarding their long-term clinical behaviour, but no data is available about patients' satisfaction with such extracoronal adhesive attachments. This research project aims to investigate patients' satisfaction with extracoronal adhesive attachments (group A) of removable dental prostheses in comparison to clasps (group B), and to investigate the short- and long-term clinical performance of both treatment options. This is a non-interventional observational study. Only routine clinical examinations are performed. No additional risks or burdens arise for participants. All measures fall under minimal risk A according to ClinO, Art. 61. Overall risk: Minimal. No invasive procedures or biological sampling. Ethical and legal standards are fully met. Sex and gender dimensions are not relevant to the topic of the study as the population is determined by patients treated since 2001 and cannot be influenced by the study design.

Вмешательства

  • Другое Patients' satisfaction and clinical investigation of removable partial denture anchorage with extracoronal adhesive attachments
    * Completion of a questionnaire by the participant, including patient satisfaction on VAS (visual analogue scale) and prostheses usability, clinical examination of the remaining dentition, the abutment teeth of the extracoronal adhesive attachment and the RPD. * Evaluation of the attachment's condition, retention, and any signs of biological or technical complications. * Collection of relevant medical and dental history from patients' records (consent provided).
  • Другое Patients' satisfaction and clinical investigation of removable partial denture anchorage with conventional clasps
    * Completion of a questionnaire by the participant, including patient satisfaction on VAS (visual analogue scale) and prostheses usability, clinical examination of the remaining dentition, the abutment teeth of the clasps and the RPD. * Evaluation of the clasps' condition, retention, and any signs of biological or technical complications. * Collection of relevant medical and dental history from patients' records (consent provided).

Первичные конечные точки

  • Patients' satisfaction with extracoronal adhesive attachments (group A) compared to conventional clasp-retained prostheses (group B) on a visual analogue scale (VAS) [Срок оценки: From 2001 to present (RDP with retention element has to be in place for at least 6 months)]
Вторичные конечные точки (2)
  • Occurrence of biological complications associated with the use of extracoronal adhesive attachments and conventional clasps [Срок оценки: From 2001 to present (RDP with retention element has to be in place for at least 6 months)]
  • Occurrence of technical complications associated with the use of extracoronal adhesive attachments and conventional clasps [Срок оценки: From 2001 to present (RDP with retention element has to be in place for at least 6 months)]

Критерии участия

Критерии включения

  • Signed informed consent.
  • Patients with at least one extracoronal adhesive attachment for anchoring an RPD and patients with clasp-retained RPD during a 25-year period (2001 - 2025) at the Department for Reconstructive Dentistry or the affiliated student course.
  • The attachment or clasp must have been in place for a minimum of six months at the time of clinical follow-up.
  • Sufficient availability of medical/dental records
  • Age ≥18 years at time of initial treatment.
  • Ability to attend a clinical follow-up appointment.

Критерии исключения

  • Patients unable to provide informed consent.
  • Incomplete or missing documentation of the prosthetic treatment.
  • Attachments or clasps inserted less than six months ago.
  • Inability to attend the follow-up appointment or language barriers preventing study understanding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • Universitäres Zentrum für Zahnmedizin Basel - Klinik für Rekonstruktive Zahnmedizin — Basel

Публикации

  • Schaffer H. [Clinical results of partial denture anchorage using extracoronal bonded attachments]. Dtsch Zahnarztl Z. 1990 Jun;45(6):326-8. German. PMID 2269117
  • Besimo C, Gachter M, Jahn M, Hassell T. Clinical performance of resin-bonded fixed partial dentures and extracoronal attachments for removable prostheses. J Prosthet Dent. 1997 Nov;78(5):465-71. doi: 10.1016/s0022-3913(97)70061-1. PMID 9399188
  • Dula LJ, Kelmendi TZ, Shala K, Staka G, Pustina-Krasniqi T, Kosumi S. Attachment-Retained versus Clasp-Retained Removable Partial Dentures: Effects of Retention on Patient Satisfaction. Eur J Dent. 2025 Jul;19(3):823-834. doi: 10.1055/s-0044-1795122. Epub 2024 Dec 30. PMID 39750515
  • Kraljevic I, Glenz F, Jordi C, Zimmermann SD, Joda T, Zitzmann NU. Long-Term Observation of Post Copings Retaining Overdenture Prostheses. Int J Prosthodont. 2020 Mar/Apr;33(2):169-175. doi: 10.11607/ijp.6629. PMID 32069341
  • Zitzmann NU, Rohner U, Weiger R, Krastl G. When to choose which retention element to use for removable dental prostheses. Int J Prosthodont. 2009 Mar-Apr;22(2):161-7. PMID 19418863
  • Brandt S, Winter A, Lauer HC, Romanos G. Retrospective clinical study of 842 clasp-retained removable partial dentures with a metal framework: survival, maintenance needs, and biologic findings. Quintessence Int. 2024 Oct 24;55(9):704-711. doi: 10.3290/j.qi.b5566187. PMID 38985439
  • Garling A, Krummel A, Kern M. Outcomes of resin-bonded attachments for removable dental prostheses. J Prosthodont Res. 2024 Jan 16;68(1):100-104. doi: 10.2186/jpr.JPR_D_22_00306. Epub 2023 May 20. PMID 37211411

Идентификаторы

NCT: NCT07160660 · PSCI2025

Первоисточники (государственные реестры)

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