Flexible RPD's have a higher impact on OHRQoL compared to acrylic RPD's.
ID
Bron
Verkorte titel
Aandoening
Missing teeth
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
OHRQoL (5-point Likert-type scale)
Achtergrond van het onderzoek
Rationale: During the healing period after ridge preservation/ridge augmentation procedures prior to implant placement, an acrylic resin tissue-supported removable partial denture (RPD) can be used as a provisional restoration in the anterior region for esthetic and functional reasons. Patients are only moderately satisfied with an acrylic RPD as a provisional restoration. A flexible design RPD might prove beneficial for patients with regard to Oral Health-related Quality of Life (OHRQoL), overall satisfaction, function, comfort and esthetics. Therefore, the aim of this within subject comparison study is to compare the patient satisfaction between a flexible RPD and an acrylic RPD with regard to OHRQoL, overall satisfaction, function, comfort, and esthetics. Objective: The primary objective is to compare OHRQoL with regard to a flexible RPD and an acrylic RPD. The second objective is to compare patient satisfaction between a flexible RPD and an acrylic RPD with regard to overall satisfaction, function, comfort, and esthetics. Study design: The study is designed as a within subject comparison study. Study population: Adult patients with a missing incisor, canine or premolar in the maxilla are included in this study. Intervention: The ridge preservation/ridge augmentation procedure will be performed according to standard protocol. During the 3-month healing period after surgery, the patients will receive a flexible RPD or acrylic RPD as a provisional restoration for the first 1.5 months according to the assigned study group. After 1.5 months, the RPD is switched. Main study parameters/endpoints: The main study parameter is OHRQoL. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients will receive one extra appointment for research purposes only in addition to the regular treatment protocol. The described parameters will be collected during regular appointments.
Doel van het onderzoek
Flexible RPD's have a higher impact on OHRQoL compared to acrylic RPD's.
Onderzoeksopzet
0 months, 1,5 months, 3 months
Onderzoeksproduct en/of interventie
Flexible RPD (1,5 month), acrylic RPD (1,5 month)
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• One missing or failing tooth (for at least 3 months), being an incisor (central or lateral), canine or premolar in the maxilla, the adjacent teeth are natural teeth;
• Large bony defect that requires a ridge preservation/ridge augmentation procedure for implant placement;
• Adequate oral hygiene (modified plaque index and modified sulcus bleeding index);
• Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
• The patient is capable of understanding and giving informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Medical and general contraindications for the surgical procedures;
• Presence of an active and uncontrolled periodontal disease;
• Bruxism;
• Smoking;
• A history of local radiotherapy to the head and neck region.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8868 |
| Ander register | METc UMCG : TBA |