NCT04298294

Brief Summary

The effect of using of i-PRF (injectable platelet rich fibrin) on filling the gap of immediate dental implant in the esthetic zone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

February 29, 2020

Last Update Submit

March 4, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone.

    density, vertical and horizontal assessment of labial plate

    6 months follow up

  • Radiographic analysis

    vertical assessment of labial plate

    6 months follow up

  • Radiographic analysis

    density of labial plate

    6 months follow up

Secondary Outcomes (1)

  • Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant

    6 months follow up

Study Arms (2)

injectable platelet rich fibrin group

EXPERIMENTAL

8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF\& bone graft

Other: injectable platelet rich fibrin

no injectable platelet rich fibrin group

NO INTERVENTION

8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft

Interventions

biologic activator

injectable platelet rich fibrin group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult patient.
  • Age from 20-50 years old
  • Patients must be free of any systemic disease which could influence the surgical procedure.
  • Tooth involved in the esthetic zone.
  • Sufficient hard and soft tissue volume in vertical and buccolingual 6. Natural teeth adjacent to the involved tooth were required to be free from infection.
  • Controlled oral hygiene.
  • Indication for tooth extraction included;
  • Endodontic failures
  • Untreatable caries\> Non- restorable teeth
  • Vertical root fracture
  • Remaining roots
  • The decision to proceed with the implant placement was made after tooth extraction and probing of the extraction socket which revealed:
  • The presence of intact facial bone.
  • Compliance with all requirements in the study and signing the informed consent.

You may not qualify if:

  • Patient had surgeries in the same site during the last 6 months prior to the surgery.
  • Severe vertical bone loss (socket type lll or type lV).
  • Presence of acute dento-alveolar infection or periodontal affected of involved tooth.
  • Pregnant and lactating females.
  • Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassant Mohye

Cairo, 11724, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Group I (study group)8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF\& bone graft Group II (control group) 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 6, 2020

Study Start

February 16, 2018

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations