Patient Satisfaction and OHRQoL In Removable Versus Fixed Implant Prostheses
Condition: Completely Edentulous Patients
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Objectives to evaluate the oral health-related quality of life and patient satisfaction in
      completely edentulous patients, when restored by maxillary and mandibular fixed
      (screw-retained) or removable telescopic retained implant supported prosthesis. 19 patients
      were randomized to receive either a fixed or a removable maxillary and mandibular full arch
      implant prosthesis. They were then asked to answer the OHIP-14 and a patient satisfaction
      questionnaire at 2 weeks, 3, 6 and 12 months post-prosthetic insertion.
    

Detailed description: 
      Interventions

      General operative procedures:

      Once the eligibility criteria were fulfilled in a patient, new complete maxillary and
      mandibular dentures were fabricated for this patient to allow for prosthetically driven
      implant placement. 4 implants were placed interforaminally so that they were parallel to each
      other. If the patient had an existing satisfactory denture, that was delivered at least six
      months ago, it was evaluated for retention, fit, support, stability, occlusion and esthetics.
      New and old dentures were later used for constructing the scan appliances.

      The patients were randomly assigned into two groups with an allocation ratio 1:1. Simple
      randomization was done by preparing sequentially-numbered, opaque, sealed envelopes, that
      contained two-times folded cards with the treatment group written inside. Accordingly, the
      patients were assigned either to group T (control treatment/ telescopic retained implant
      supported removable overdentures) or group S (test treatment/ screw retained implant
      supported fixed prosthesis).

      The intervention arm : Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic
      cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary
      copings of the telescopic prosthesis.The finished primary copings were scanned using a lab
      scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and
      to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings
      Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to
      the primary coping. The framework was then tried in. At that time it was ready for its
      intra-oral luting to the secondary copings.

      the control treatment: Once adequate fit of the framework of the hybrid prosthesis was
      achieved, the wax of the trial denture was converted into heat-cured acrylic resin using
      conventional packing and flasking techniques. The prosthesis was finished, polished and
      screwed in the patient's mouth.

      Lack of blinding of the operator, the participants and the assessor (patient) due to the
      obvious dissimilarity between the treatment arms, could have created performance and
      assessment bias. In an attempt to decrease the performance bias, randomization was delayed
      until the abutments were connected. When the prosthesis was delivered to the patient, they
      were requested to answer OHIP-14 and patient satisfaction questionnaires 2 weeks after
      prosthetic insertion, then 3, 6 and 12 months later.

      The aim of this RCT was to evaluate patient satisfaction and oral-health related quality of
      life in completely edentulous patients receiving removable implant overdentures versus fixed
      implant hybrid restorations.

      Data were statistically described in terms of mean +/- standard deviation (+/- SD), median
      and range. Comparison of ordinal variables between the study groups was done using Mann
      Whitney U test for independent samples. Within group comparison of the ordinal data was done
      using Friedmann test to detect significant differences between time in periods. This was
      followed by Wilcoxon signed rank test for paired comparisons. Two sided p values less than
      0.05 was considered statistically significant. Additionally, a correlation between relevant
      domains of the OHIP-14 and the patient satisfaction questionnaires was done using Spearman
      rank correlation test. All statistical calculations were done using computer program IBM SPSS
      (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for
      Microsoft Windows
    

Intervention name(s): maxillary and mandibular telescopic retained overdentures supported by 4 implants; maxillary and mandibular screw retained hybrid prostheses supported by 4 implants
Intervention type(s): Procedure; Procedure
Intervention description(s): The wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth. Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.; Framework of the hybrid prosthesis is waxed using plastic copings attached to multiunit abutments. once the framework is finished , bite is recorded, teeth are set up and the waxed up prosthesis are tried in. IF accepted the wax is eliminated the wax up denture is converted inti heat cured acrylic resin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment