Gelatin Sponge VS PTFE Membrane for Socket Sealing After Immediate Implant Placement
NCT ID: NCT05982353
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2022-06-01
2023-10-30
Brief Summary
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Follow-up appointments at 1,3 weeks and 1,2 \& 3 months were planned.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PTFE application with immediate implantation
this group received PTFE membranes during immediate implantation as the gold standard
PTFE application
Polytetrafluoroethylene membrane used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup
Gelatin Sponge application with immediate implantation
this group received gelatin sponges during immediate implant placement
Gelatin sponge
gelatin sponge used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup
Interventions
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PTFE application
Polytetrafluoroethylene membrane used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup
Gelatin sponge
gelatin sponge used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup
Eligibility Criteria
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Inclusion Criteria
* generally healthy patients 22-50 years of age
* non smokers
* good oral hygiene
Exclusion Criteria
* poor oral hygiene
* non compliant patient
22 Years
50 Years
ALL
Yes
Sponsors
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National Research Centre, Egypt
OTHER
Cairo University
OTHER
Responsible Party
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Alaa Emara
A.Professor OMFS
Principal Investigators
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Noha ElAdl, PhD
Role: STUDY_DIRECTOR
National Research Centre, Egypt
Locations
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National Research centre
Cairo, , Egypt
Countries
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References
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Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.
Araujo MG, Silva CO, Souza AB, Sukekava F. Socket healing with and without immediate implant placement. Periodontol 2000. 2019 Feb;79(1):168-177. doi: 10.1111/prd.12252.
El Helow K, El Askary Ael S. Regenerative barriers in immediate implant placement: a literature review. Implant Dent. 2008 Sep;17(3):360-71. doi: 10.1097/ID.0b013e3181813406.
Carbonell JM, Martin IS, Santos A, Pujol A, Sanz-Moliner JD, Nart J. High-density polytetrafluoroethylene membranes in guided bone and tissue regeneration procedures: a literature review. Int J Oral Maxillofac Surg. 2014 Jan;43(1):75-84. doi: 10.1016/j.ijom.2013.05.017. Epub 2013 Jun 28.
Sharifi S, Maleki Dizaj S, Ahmadian E, Karimpour A, Maleki A, Memar MY, Ghavimi MA, Dalir Abdolahinia E, Goh KW. A Biodegradable Flexible Micro/Nano-Structured Porous Hemostatic Dental Sponge. Nanomaterials (Basel). 2022 Sep 30;12(19):3436. doi: 10.3390/nano12193436.
Sohn DS, Moon JW, Moon KN, Cho SC, Kang PS. New bone formation in the maxillary sinus using only absorbable gelatin sponge. J Oral Maxillofac Surg. 2010 Jun;68(6):1327-33. doi: 10.1016/j.joms.2010.02.014.
Chang B, Tang Y, Wei X, Li S. A New Application of Gelatin Sponge in the Treatment of Hemifacial Spasm by Microvascular Decompression: A Technical Note. J Neurol Surg A Cent Eur Neurosurg. 2022 Mar;83(2):183-186. doi: 10.1055/s-0040-1720994. Epub 2021 May 19.
Chanu NR, Bhattacharya K, Marbaniang D, Pal P, Ray S, Mazumder B. Evaluation of a novel melatonin-loaded gelatin sponge as a wound dressing. J Vasc Nurs. 2022 Mar;40(1):2-10. doi: 10.1016/j.jvn.2021.09.004. Epub 2021 Oct 20.
Other Identifiers
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PTFEvsGelatin
Identifier Type: -
Identifier Source: org_study_id
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