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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03992573
Other study ID # 0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date June 1, 2020

Study information

Verified date June 2019
Source Medical Universtity of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The research was conducted in twenty patients with symmetric single tooth qualified to extraction. On one side of dental arch, post-operative region was field with CGF material, while on the other side it was left to normal healing. In both cases pain, swelling, alveolar osteitis, antibiotics and analgesics intake in post-operative period were evaluated in the first, fourth and seventh day after surgery. Wound healing was assessed seven and thirty days after extraction.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- no known medical history of abnormal platelet counts,

- patients with symmetric teeth qualified for extraction,

Exclusion Criteria:

- systemic diseases,

- pregnancy,

- lactation,

- drugs known to affect the number or function of platelets,

- abnormal platelet counts

Study Design


Intervention

Procedure:
CGF application
CGF application into post-operative soft tissue and bone defects

Locations

Country Name City State
Poland Department of Oral Surgery Lodz

Sponsors (1)

Lead Sponsor Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Occurrence of swelling The presence of swelling was evaluated using zero one system. 24 hours
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