Clinical trial NCT05982353: Gelatin Sponge VS PTFE Membrane for Socket Sealing After Immediate Implant Placement
Official title: Effect of Using a Hemostatic Gelatin Sponge Versus a Dense Polytetrafluorethylene Membrane for Socket Sealing Following Immediate Implant Placement. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Implant Failed
Teeth Absent
Soft Tissue Injuries
Keywords: PTFE
immediate Implantation
Gelatin sponge
Dental socket
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2023-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients with dental sockets requiring immediate implantation with Gelatin Sponge vs polytetrafluoroethylene membrane
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: reverse torque test
timeFrame: 3 months after implant placement
Secondary outcomes:
measure: Clinical soft tissue healing
timeFrame: 2,3 weeks and 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research centre
Study officials:
affiliation: National Research Centre, Egypt
name: Noha ElAdl, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.