Immediately Placed Implant Sealed With Platelets Rich Fibrin Versus Cyanoacrylate Glue

Assessment of Soft Tissue Healing Over Immediately Placed Implant Sealed With Platelets Rich Fibrin (Prf) Versus Cyanoacrylate Glue (a Randomized Controlled Clinical Trial)

The health of peri-implant soft tissues is one of the most important aspects necessary for the long-term survival of dental implants. The importance of the peri-implant mucosal region lies in the need to establish a tight seal that isolates the implant and the bone from the oral environment. Study objective is to clinically compare the soft tissue healing, height, and thickness over immediate implants placed in type I sockets sealed by PRF to those sealed by a Cyanoacrylate glue.

Study Overview

• Status: Active, not recruiting
• Conditions: Tooth Socket
• Intervention / Treatment: Other: Cyanoacrylate glue; Other: Platelet-rich fibrin (PRF)

Detailed Description

the study will be conducted on 16 extraction sockets in humans. Sockets will be randomly divided into two groups: Group I (test) will comprise 8 sockets sealed by PRF after immediate implant placement. Group II: (test) will comprise 8 sockets sealed by cyanoacrylate glue after immediate implant placement

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any non-restorable hopeless tooth; a badly decayed tooth that cannot be restored, a Tooth with failed endodontic treatment, and tooth with longitudinal fracture.
• Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue graft
• A good standard of oral hygiene.
• No signs of active periodontal disease in the selected tooth.

Exclusion Criteria:

• The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
• The presence of Acute periapical infection.
• The presence of any local factor that may interfere with extraction as tooth ankyloses. (
• Subjects who had undergone therapeutical radiation. (38)
• Patients who had been subjected to or who were under bisphosphonate therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group	Other: Platelet-rich fibrin (PRF); 8 sockets that will be treated by immediate implant placement and sealed by PRF.
EXPERIMENTAL: Study group	Other: Cyanoacrylate glue; 8 sockets that will be treated by immediate implant placement and sealed by a Cyanoacrylate glue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in soft tissue healing	Soft tissue healing will be assessed in both groups in reference to the soft tissue healing index according to Landry index Landry index scores Very poor: Tissue color: ≥50% of gingiva red Response to palpation: BleedingGranulation tissue: PresentIncision margin: Not epithelialized, with loss of epithelium beyond incision marginSuppuration: Present Poor: Tissue color: ≥50% of gingiva red Response to palpation: BleedingGranulation tissue: PresentIncision margin: Not epithelialized, with connective tissue exposed Good: Tissue colour: ≥25% and<50% of gingiva redResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed Very good: Tissue colour: <25% of gingiva redResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed Excellent: Tissue color: All tissues pinkResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed	at 2nd week and 4th week
Change in Mid crestal soft tissue thickness	Mid crestal soft tissue thickness over the immediate implant will be measured using a periodontal probe passing through soft tissue in the intersection midpoint of both buccolingual and mesiodistal dimensions of the socket till cover screw, after 4 weeks postoperatively	at baseline and after 4 weeks
change in Mid-buccal soft tissue height	Mid-buccal soft tissue height: will be measured from gingival margin to implant platform, at surgery time and 4 weeks postoperatively	at baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2021
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (ACTUAL): June 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Cyanoacrylates_2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No