Immediately Placed Implant Sealed With Platelets Rich Fibrin Versus Cyanoacrylate Glue

Not Applicable

• Conditions: Tooth Socket
• Interventions: Other: Cyanoacrylate glue; Other: Platelet-rich fibrin (PRF)

• Registration Number: NCT05437744
• Lead Sponsor: Hams Hamed Abdelrahman

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

Study Timeline

• Study Start: 2021-12-12
• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Study First Posted: 2022-06-29
• Last Update Posted: 2022-06-29
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Cyanoacrylate glue	-
Control group	Platelet-rich fibrin (PRF)	-

Primary Outcome Measures

Name	Time	Method
Change in Mid crestal soft tissue thickness	at baseline and after 4 weeks	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
Change in soft tissue healing	at 2nd week and 4th week	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
change in Mid-buccal soft tissue height	at baseline and after 4 weeks	Mid-buccal soft tissue height: will be measured from gingival margin to implant platform, at surgery time and 4 weeks postoperatively

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt