Dental Implant Failed, Teeth Absent, Soft Tissue Injuries
Conditions
Keywords
PTFE, immediate Implantation, Gelatin sponge, Dental socket
Brief 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.
Interventions
DEVICEPTFE application
Polytetrafluoroethylene membrane used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup
DEVICEGelatin sponge
gelatin sponge used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup
Sponsors
National Research Centre, Egypt
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
blinded envelopes selected by operator
Intervention model description
patients with dental sockets requiring immediate implantation with Gelatin Sponge vs polytetrafluoroethylene membrane
Eligibility
Sex/Gender
ALL
Age
22 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* patients with badly broken down tooth indicated for immediate implantation * generally healthy patients 22-50 years of age * non smokers * good oral hygiene
Exclusion criteria
* poor bone quality * poor oral hygiene * non compliant patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reverse torque test | 3 months after implant placement | the implants will be subjected to a reverse torque test of 30 N/cm using a calibrated torque wrench. this should identify proper osseointegration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical soft tissue healing | 2,3 weeks and 3 months | incidence of infection/ improper tissue closure/dehiscence. will be assessed by to different blinded investigators using the Inflammatory Proliferative Remodeling scoring scale |
Countries
Egypt
Outcome results
None listed