Immediately Placed Implant Sealed With Platelets Rich Fibrin Versus Cyanoacrylate Glue

Tooth Socket Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05437744
• Other study ID #: Cyanoacrylates_2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 12, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Socket

Intervention

Other:
• Cyanoacrylate glue
8 sockets that will be treated by immediate implant placement and sealed by a Cyanoacrylate glue.
• Platelet-rich fibrin (PRF)
8 sockets that will be treated by immediate implant placement and sealed by PRF.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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