NCT03992573

Brief Summary

The aim of the study is to evaluate the influence of CGF application into post-operative soft tissue and bone defects on post-operative complications and wound healing.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 8, 2019

Status Verified

June 1, 2019

Enrollment Period

2.4 years

First QC Date

June 18, 2019

Last Update Submit

July 5, 2019

Conditions

CGFBone LossPost-operative Wound Healing

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain vs. CGF application

    In order to evaluate the relationship between intensity of pain after surfery and filling the alveolus with platelet-rich plasma, , NRS (Numeric Rating Scale) pain scale is used. NRS scale, ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain.

    24 hours

Secondary Outcomes (1)

  • Occurrence of swelling

    24 hours

Study Arms (2)

Study group

EXPERIMENTAL
Procedure: CGF application

Control group

NO INTERVENTION

Interventions

CGF applicationPROCEDURE

CGF application into post-operative soft tissue and bone defects

Study group

Eligibility Criteria

Age18 Years - 90 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:

  • 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

RECRUITING

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

October 1, 2017

Primary Completion

March 1, 2020

Study Completion

June 1, 2020

Last Updated

July 8, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)