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

Phase 1

Completed

• Conditions: Soft Tissue Injuries; Teeth Absent; Dental Implant Failed
• Interventions: Device: PTFE application; Device: Gelatin sponge

• Registration Number: NCT05982353
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-06-01
• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-08-05
• Study First Posted: 2023-08-08
• Study Completion: 2023-10-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• poor bone quality
• poor oral hygiene
• non compliant patient

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTFE application with immediate implantation	PTFE application	this group received PTFE membranes during immediate implantation as the gold standard
Gelatin Sponge application with immediate implantation	Gelatin sponge	this group received gelatin sponges during immediate implant placement

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Research centre; 🇪🇬 Cairo, Egypt