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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04298294
Other study ID # Bassant Mohye
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 16, 2018
Est. completion date December 1, 2019

Study information

Verified date March 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
injectable platelet rich fibrin
biologic activator

Locations

Country Name City State
Egypt Bassant Mohye Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Radiographic analysis vertical assessment of labial plate 6 months follow up
Primary Radiographic analysis density of labial plate 6 months follow up
Secondary Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant pink esthetic score 6 months follow up
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