Gelatin Sponge VS PTFE Membrane for Socket Sealing After Immediate Implant Placement
Condition: Dental Implant Failed; Teeth Absent; Soft Tissue Injuries
MeSH terms: Soft Tissue Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Digital panoramas will be made to assess the implant sites. The included patients are
      assigned to their respective groups randomly. After implant submerging in the study group 2
      layers of hemostatic resorbable gelatin sponge is fixed in the implant site; while with the
      control group PTFE is fixed. After 3 weeks the PTFE was removed while the gelatin sponge
      should be resorbed. 3 months later the implants are to be assessed for stability and a
      reverse torque test was used to confirm osseointegration during uncovering.

      Follow-up appointments at 1,3 weeks and 1,2 & 3 months were planned.
    

Detailed description: 
      Dental implants are considered the gold standard for treatment of edentulous spaces.
      Immediate implant placement has multiple advantages including the shorter treatment span,
      less surgical procedures and faster loading possibility [1]. One of the drawbacks of
      immediate implant placement is proper soft tissue coverage of the submerged implant to
      prevent socket infection and allow implant stability and osseointegration [2]. To overcome
      these issues the use of membranes has been the standard procedure [3].

      Polytetrafluoroethylene membranes (PTFE) have been reported vastly in literature and their
      results and clinical effect on soft tissue healing and guided tissue regeneration (GTR)
      around implants and in surgical sites. Dense PTFE allows for GTR by only promoting
      non-bacterial migration and improving cellular adhesion which promotes tissue regeneration
      underneath it [4]. On the other hand, PTFE membranes are quite expensive and with the
      economic crisis the world is facing the use of other less expensive options is crucial.
      Gelatin sponges are vastly used as hemostatic agents in minor surgical procedures and have
      shown excellent results in terms of hemostasis and rapid resorption [5]. The application of
      such material are multiple; such as with sinus lift procedures [6], microvascular
      decompression[7] and as a wound dressing [8].

      The investigators hereby propose the use of hemostatic gelatin sponges as membranes for
      submerged immediate implants as a simpler and cheaper alternative to PTFE.
    

Intervention name(s): PTFE application; Gelatin sponge
Intervention type(s): Device; Device
Intervention description(s): Polytetrafluoroethylene membrane used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup; gelatin sponge used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients with dental sockets requiring immediate implantation with Gelatin Sponge vs polytetrafluoroethylene membrane
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: PTFE; immediate Implantation; Gelatin sponge; Dental socket