Gelatin Sponge VS PTFE Membrane for Socket Sealing After Immediate Implant Placement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Using a Hemostatic Gelatin Sponge Versus a Dense Polytetrafluorethylene Membrane for Socket Sealing Following Immediate Implant Placement. A Randomized Clinical Trial

Conditions
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Immediate Implantation, Badly Broken Down Tooth, Gelatin Sponge for Socket Healing

Intervention / Treatment
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* Other: PTFE application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients with dental sockets requiring immediate implantation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: PTFE application with immediate implantation<br>this group received PTFE membranes during immediate implantation as the gold standard | Other: PTFE application<br>* Polytetrafluoroethylene membrane vs gelatin sponge used over immediate implants<br>* Other names: Gelatin sponge application;|
| Experimental: Gelatin Sponge application with immediate implantation<br>this group received gelatin sponges during immediate implant placement | Other: PTFE application<br>* Polytetrafluoroethylene membrane vs gelatin sponge used over immediate implants<br>* Other names: Gelatin sponge application;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reverse torque test | the implants will be subjected to a reverse torque test of 30 N/cm using a calibrated torque wrench. this should identify proper osseointegration. | 3 months after implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical soft tissue healing | incidence of infection/ improper tissue closure/dehiscence. will be assessed by to different blinded investigators using the IPR scoring scale | 2,3 weeks and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTFE, immediate Implantation, Gelatin sponge, Dental socket