Maintenance Assessment For Implant Fixed Complete Dentures With Implant Overdentures. A RCT
Condition: Complications Implants
Study type: Interventional

Summary: 
      There are two types of complications in implant prosthesis: biologic and prosthetic .
      Biologic complications refer to disorders in implant function that disturb the supporting
      peri-implant tissues resulting in mucositis or periimplantitis in severe conditions, the
      technical complications refer to subjecting the implant, implant parts and /or the
      superstructures to a damage ,such as screw loosening ,attachment wear, fracture to part of
      the prosthesis or some of its teeth. Prosthetic complications after the insertion of the
      final prosthesis may or may not lead to implant loss but lead to an increase demand for
      repair and maintenance.

      This study aimed to assess whether the telescopic overdenture as a removable prosthesis would
      necessitate maintaince at frequency similar to that with screw retained hybrid overdenture as
      a fixed prosthesis.
    

Detailed description: 
      Sample size calculation This power analysis used frequency of implant complications as the
      primary outcome. Based upon the results of Ragheb NA et al (2021) [15];the proportions of
      complications were 0.407 and 0.037 in the two groups, respectively. Using alpha (α) level of
      (5%) and Beta (β) level of (20%) i.e., power = 80%; the minimum estimated sample size was 19
      implants per group. Sample size was increased to twenty-two implants per group to compensate
      for a drop-out rate of 30% after two years. Sample size calculation was performed using
      G*Power Version 3.1.9.2.

      Patients were recruited in the study from the Outpatient Clinic of the Prosthodontics
      Department, Faculty of Dentistry, Cairo University. All of which were dissatisfied from their
      previous denture experience and seeking better retention to their mandibular denture.
      Patients had received verbal and written information about the study procedures and a written
      informed consent was signed prior to participation.

      This study is a randomized clinical trial which was approved by the Ethics Committee of
      Scientific Research of Cairo University.

      In this study , all participants had to install four interforaminal implants to receive
      either telescopic over-denture or screw retained denture.

      Before the prosthetic phase, both groups were randomly assigned according to a computerized
      random allocation program where data of randomization were entered by the secretary of the
      department who neither participated in recruitment nor in examination procedures.

      Randomization and Allocation concealment was guaranteed as the randomization table was locked
      with the study coordinator who wasn't involved in any clinical intervention. operator was
      informed about the treatment modality in a sealed enveloped delivered by the secretary of the
      department before impression procedures.

      Data collection was done by the study coordinator , Blinding of the operator or data
      collector was not applicable due to the clear difference between the two prostheses but
      collected data was coded prior to sending to the statistician (blinded statistician).

      A preoperative CBCT scan was taken for the participant 's mandibular arch with a scan
      appliance .The surgical steps were explained for all the participants and an informed consent
      was signed before surgery.

      Intra-foraminal root form tapered threaded dental implants (Neo Biotech Co. Ltd, Seoul,
      Korea) were installed with 3.5/ 11.5 mm for the anterior and 3.5/10 mm for posterior sites .

      Three months later, the surgical stent was used to relocate the implants position for
      uncovering and the healing abutment was screwed with collar height 5mm to allow for proper
      gingival healing around the implants prior making the impression.

      The impression was made with an open tray splinted implant level impression technique
      According to randomization, either a telescopic implant supported overdenture or a screw
      retained denture was fabricated for each case.

      During the follow -up period, prosthetic complications were grouped and their frequency was
      documented according to the type of prosthesis . Both prosthetic and biological aspects were
      included.

      Each complication was documented with stating the frequency of its occurrence, any
      complication was managed and repaired.
    

Intervention name(s): screw retained prosthesis group
Intervention type(s): Other
Intervention description(s): hybrid prosthesis screwed on four mandibular intra-foraminal implants
Other intervention name(s): hybrid prosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental Prosthesis, Implant-Supported*, Denture, Overlay