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OpenTrials
Completed

NCT Number: NCT05982353

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

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.

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Key information

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Research centre

Cairo, 11234, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTFE application

Device

Polytetrafluoroethylene membrane used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup

Gelatin sponge

Device

gelatin sponge used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup

Primary outcomes

  1. reverse torque test

    Time frame: 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 outcomes

  1. Clinical soft tissue healing

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • National Research Centre, Egypt

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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