Universitäres Zentrum für Zahnmedizin Basel - Klinik für Rekonstruktive Zahnmedizin
Basel, 4058, Switzerland
NCT Number: NCT07160660
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Basel, 4058, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From 2001 to present (RDP with retention element has to be in place for at least 6 months)
The primary objective of this study is to assess patients' satisfaction with extracoronal adhesive attachments (group A) compared to conventional clasp-retained prostheses (group B) on a visual analogue scale (VAS).
The scale ranges from 0 - 100. A lower score means a worse outcome (satisfaction low) and a higher score a better outcome (satisfaction high). The participants will be instructed and asked to mark a point on the scale according to their satisfaction with the extracoronal adhesive attachment or the clasp-retained prostheses.
Time frame: From 2001 to present (RDP with retention element has to be in place for at least 6 months)
At the recall appointment, a clinical examination of the remaining dentition and the prostheses will be performed. The primary assessment will determine whether the abutment tooth with the attachment/clasp remains in situ. The secondary assessment includes a clinical evaluation of the periodontal and endodontic conditions. All biological complications such as caries lesions, tooth fractures, periodontal attachment loss, and endodontic pathologies of the abutment teeth will be reported in a standardized dental record.
If consent is given, relevant information from the existing dental records will also be extracted for analysis.
Time frame: From 2001 to present (RDP with retention element has to be in place for at least 6 months)
At the recall appointment, a clinical examination of the remaining dentition and the prostheses will be performed. The assessment includes a clinical evaluation of the technical condition of the attachment/clasp and the RDP, such as comprise loss of retention between the extracoronal adhesive attachment and the corresponding matrice, loss of the matrice, debonding of the attachment, fracture of the attachment or clasps, deactivation of the clasps, fracture of the removable dental prostheses. The findings will be reported in a standardized dental record.
If consent is given, relevant information from the dental records will also be extracted for analysis.
University of Basel
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.