NCT04476121

Brief Summary

The aim of the study is to evaluate the influence of PRF application in case of alveolar osteitis.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration 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

January 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 26, 2021

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

July 15, 2020

Last Update Submit

April 23, 2021

Conditions

Keywords

dry socketPRF

Outcome Measures

Primary Outcomes (2)

  • Intensity of pain vs. PRF and Nipas application

    In order to evaluate the relationship between intensity of pain after application of PRF and Nipas, Numeric Rating Scale pain scale is used. NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. The higher score means worse outcome in case of present study.

    24 hours

  • Influence of treatment on bacteria levels in wounds

    The second part of the study was dedicated to analyzing the number of bacteria in tooth extraction wounds.

    24 hours

Study Arms (2)

PRF application

EXPERIMENTAL

Patients with alveolar osteitis in which PRF application was performed.

Procedure: PRF application

Aspirin application

ACTIVE COMPARATOR

Patients with alveolar osteitis in which Nipas was used.

Drug: Nipas application

Interventions

PRF application into post-operative wound.

PRF application

Nipas application into post-operative wound.

Also known as: Aspirin paste
Aspirin application

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no known medical history of abnormal platelet counts,
  • patients with symmetric teeth qualified for extraction,

You may not qualify if:

  • patients treated previously for existing dry socket,
  • patients allergic to acetylsalicylic acid ,
  • systemic diseases,
  • pregnancy,
  • lactation,
  • drugs known to affect the number or function of platelets,
  • abnormal platelet counts,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral Surgery

Lodz, 92-213, Poland

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Anna Janas-Naze, Prof.

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The first medicine was applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth in the same patient and reoccurrence of dry socket, patients were treated with PRF application.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 17, 2020

Study Start

January 1, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

April 26, 2021

Record last verified: 2020-06

Locations