Immediately Placed Implant Sealed With Platelets Rich Fibrin Versus Cyanoacrylate Glue

NCT ID: NCT05437744

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-12
• Study Completion Date: 2022-08-01

Brief Summary

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.

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

Conditions

Tooth Socket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Group Type: EXPERIMENTAL

Cyanoacrylate glue

Intervention Type: OTHER

8 sockets that will be treated by immediate implant placement and sealed by a Cyanoacrylate glue.

Control group

Group Type: ACTIVE_COMPARATOR

Platelet-rich fibrin (PRF)

Intervention Type: OTHER

8 sockets that will be treated by immediate implant placement and sealed by PRF.

Interventions

Cyanoacrylate glue

8 sockets that will be treated by immediate implant placement and sealed by a Cyanoacrylate glue.

Intervention Type: OTHER

Platelet-rich fibrin (PRF)

8 sockets that will be treated by immediate implant placement and sealed by PRF.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Alexandria Faculty of Dentistry

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

Cyanoacrylates_2021

Identifier Type: -

Identifier Source: org_study_id