An interventional study of Removable partial denture PEEK in Prosthesis Survival, sponsored by Malo Clinic. Terminated at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by Malo Clinic · Not applicable, Interventional, and Treatment
The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin removable partial denture used in partial edentulous rehabilitation after one year of follow-up. The main question it aims to answer is:
- What is the survival outcome of partial rehabilitations using Poly-ether-ether-ketone-acrylic resin removable partial dentures? The participants will receive a definitive removable partial denture incorporating Poly-ether-ehter-ketone.
Folowing the recent applications of polyetheretherketone (PEEK) material in Dentistry it is necessary to further extend the evaluation to the use of Removable Partial Denture (RPD) rehabilitations. To test this, the study design to be used will be a single-centre, prospective observational cohort study to evaluate the short term outcome of the Removal Partial Denture (RPO) supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated at baseline, RPD design, dental fitting, follow-up assessment at 4 weeks, 6 and 12 months after dental loading regarding: JUVORA prosthetic survival including repair and relining, assessment of the adaptation of the RPD frame, adaptation of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetics assessment (staining, color stability, anatomic form), oral health assessment of the RPD abutment teeth periodontium (plaque index, gingival index, probing pocket depths, bleeding on probing, mobility) incidence of mechanical complications (loosening or fracture of prosthetic components), patient assessment of RPD comfort, aesthetics and chewing ability; assessment of RPD preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's enrollment of 10 is below the median of 36 across 69 interventional studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Malo Clinic is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Removable partial denture using PEEK-acrylic resin
Device: Removable partial denture PEEK
A removable partial denture incorporating PEEK and acrylic resin in its composition used as definitive prosthesis to rehabilitate partial edentulism in the maxilla or mandible.
Also known as: PEEK prosthesis
Survival of the prosthesis
Evaluation of the survival for the PEEK-acrylic resin removable partial denture; nominal (survival,failure)
Time frame: one year
Assessment of the adaptation of the RPD frame
Nominal: 0: adapted; 1: not adapted
Time frame: one year
Function of RPD is excellent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time frame: one year
Aesthetics of RPD are excellent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time frame: one year
Staining of RPD is absent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time frame: one year
Color stability is maintained
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time frame: one year
Anatomic form of RPD is maintained
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time frame: one year
Incidence of mechanical complications
Loosening or fracture of prosthetic components Nominal: O: absence; 1: presence
Time frame: one year
Incidence of biological complications
Presence of periodontal pathology Nominal: O: absence; 1: presence
Time frame: one year
Plaque accumulation around RPD abutment teeth.
Simplified Oral Hygiene Index (Greene and Vermelion, 1964). Ordinal: 0: no debris or stain present; 1: Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered; 2: Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface; 3: Soft debris covering more than two thirds of the exposed tooth surface.
Time frame: one year
Bleeding around RPO abutment teeth
Gingival index (Loe and Silness 1963)'. Ordinal: 0: absence of inflammation/normal gingiva; 1: mild inflammation, slight change in color, slight edema, no bleeding on probing; 2: moderate inflammation, moderate glazing, redness, edema and hypertrophy, bleeding on probing; 3: severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
Time frame: one year
Probing pocket depths around RPD Dependent variable abutment teeth measured in millimeters
Measured through probing with a periodontal probe, evaluated on all tooth aspects. Scale: Distance between mucosal margin and probe stop measured in millimeters.
Time frame: one year
Mobility of RPO abutment teeth
Mobility classification (Miller 1950). Ordinal: 0: no detected mobility; 1: first sign of movement greater than normal; 2: up to 1 mm in any direction; 3: more than 1 mm in any direction and/or vertical depression.
Time frame: one year
ln mouth comfort
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time frame: one year
Oral Health Impact Profile OHIP-14
Oral Health Impact Profile OHIP-14 questionnaire
Time frame: one year
Plan to share: Yes — Anonymized database containing the study variables
Supporting information: Statistical analysis plan
Time frame: Upon study completion and for 8 years.
Access criteria: Upon solicitation to the Investigators
No publications or documents are linked to this record.
Ran from Dec 2019 to primary completion in Mar 2025, 63 months.
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This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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