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

NCT05982353 | Completed Phase 1

• 1 other identifier: PTFEvsGelatin
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Failed; Teeth Absent; Soft Tissue Injuries

Keywords

PTFE; immediate Implantation; Gelatin sponge; Dental socket

Outcome Measures

Primary Outcomes (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.

  3 months after implant placement

Secondary Outcomes (1)

• Clinical soft tissue healing

  2,3 weeks and 3 months

Study Arms (2)

PTFE application with immediate implantation

SHAM COMPARATOR

this group received PTFE membranes during immediate implantation as the gold standard

Device: PTFE application

Gelatin Sponge application with immediate implantation

EXPERIMENTAL

this group received gelatin sponges during immediate implant placement

Device: Gelatin sponge

Interventions

PTFE application DEVICE

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

PTFE application with immediate implantation

Gelatin sponge DEVICE

gelatin sponge 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

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

National Research centre

Cairo, 11234, Egypt

Location

Related Publications (8)

• 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.

  PMID: 28000278 BACKGROUND

• 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.

  PMID: 30892762 BACKGROUND

• 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.

  PMID: 18784536 BACKGROUND

• 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.

  PMID: 23810680 BACKGROUND

• 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.

  PMID: 36234564 BACKGROUND

• 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.

  PMID: 20493382 BACKGROUND

• 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.

  PMID: 34010981 BACKGROUND

• 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.

  PMID: 35287830 BACKGROUND

MeSH Terms

Conditions

Anodontia; Soft Tissue Injuries

Interventions

Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Study Officials

• Noha ElAdl, PhD

  National Research Centre, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: blinded envelopes selected by operator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A.Professor OMFS

Model Details: patients with dental sockets requiring immediate implantation with Gelatin Sponge vs polytetrafluoroethylene membrane

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 8, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: October 30, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)