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Dental Implant FailedPhase 1NCT05982353

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

A Phase 1 study testing PTFE application and Gelatin sponge in people with Dental Implant Failed and Teeth Absent, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 50 yearsHealthy volunteers can take part
What is being tested?
PTFE application and Gelatin sponge
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteEgypt
Study dates
1 Jun 2022to 30 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • patients with badly broken down tooth indicated for immediate implantation
  • generally healthy patients 22-50 years of age
  • non smokers
  • good oral hygiene

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • National Research centre

    Cairo, 11234

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
PTFE application, Gelatin sponge
Keywords
PTFE, immediate Implantation, Gelatin sponge, Dental socket
Medical subject headings
Anodontia, Soft Tissue Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTFE applicationDevice

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

  • Gelatin spongeDevice

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

Study groups in NCT05982353
Study groupRoleWhat they receive
PTFE application with immediate implantationSham comparatorthis group received PTFE membranes during immediate implantation as the gold standard
Receives: Device: PTFE application
Gelatin Sponge application with immediate implantationExperimentalthis group received gelatin sponges during immediate implant placement
Receives: Device: Gelatin sponge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months after implant placement

Secondary outcomes (1)

  1. Clinical soft tissue healing

    incidence of infection/ improper tissue closure/dehiscence. will be assessed by to different blinded investigators using the Inflammatory Proliferative Remodeling scoring scale

    Measured: 2,3 weeks and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start1 Jun 2022
  3. Primary completion1 Jun 2023
  4. Study completion30 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
patients with dental sockets requiring immediate implantation with Gelatin Sponge vs polytetrafluoroethylene membrane
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05982353
Sponsor's protocol ID
PTFEvsGelatin
Status last verified
Feb 2024
First submitted
30 Jul 2023
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28000278

  • 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.

    PubMed 30892762

  • 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.

    PubMed 18784536

  • 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.

    PubMed 23810680

  • 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.

    PubMed 36234564

  • 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.

    PubMed 20493382

  • 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.

    PubMed 34010981

  • 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.

    PubMed 35287830

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PTFE application and Gelatin sponge in people with Dental Implant Failed and Teeth Absent, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

reverse torque test (time frame: 3 months after implant placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05982353, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.

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