NCT05437744

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 27, 2022

Last Update Submit

June 27, 2022

Conditions

Tooth Socket

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Study group

EXPERIMENTAL
Other: Cyanoacrylate glue

Control group

ACTIVE COMPARATOR
Other: Platelet-rich fibrin (PRF)

Interventions

Cyanoacrylate glueOTHER

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

Study group
Platelet-rich fibrin (PRF)OTHER

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

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Interventions

MK 6 cyanoacrylate

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 29, 2022

Study Start

December 12, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

June 29, 2022

Record last verified: 2022-06

Locations

EG(1)