Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant

The Effect of Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant in the Esthetic Zone

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

Study Overview

• Status: Completed
• Conditions: Bone Loss
• Intervention / Treatment: Other: injectable platelet rich fibrin

Detailed Description

Grouping the samples: (sixteen patients was recruited from the outpatient clinic of Oral Medicine, Periodontology, Diagnosis and Radiology Department, Faculty of Dentistry, Ain Shams University).

The sixteen patients assigned to group 1 or group 2 will be randomly allocated using flip of a coin into one of the 2 treatment modalities.

Primary objective:

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

Secondary objective:

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11724
    • Bassant Mohye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: injectable platelet rich fibrin group; 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF& bone graft	Other: injectable platelet rich fibrin; biologic activator
No Intervention: no injectable platelet rich fibrin group; 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant	pink esthetic score	6 months follow up

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: February 29, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Bassant Mohye

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No