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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04434703
Other study ID # 6-3-1
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date September 1, 2021

Study information

Verified date January 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction


Description:

systemically healthy patients who have at least one non-restorable tooth in the upper inter-bicuspid region and are not seeking immediate or early implant treatment will be allocated in this study after performing nonsurgical periodontal therapy and preoperative periapical therapy to evaluate and improve the condition of the periodontal tissues. Anesthesia will be given then flapless atraumatic extraction using periotomes followed by forceps after luxation. For all groups, the socket will be debrided using curette then - group A, the socket will be filled with A.PRF - group B the socket will be filled with PRF. - group C no bio-additive will be added. - Criss cross horizontal mattress suture will be applied to close the extraction wound. PRF and A-PRF preparation : 10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein. - Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant - Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date September 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Patients with at least one non restorable tooth in upper inter-bicuspid region. - Stable periodontal condition with no acute periapical infection. - Systematically healthy conditions. - Cooperative patients. - Intact buccal plate of bone. Exclusion Criteria: - Smokers. - Patients seeking immediate or early implants. - Pregnant females. - Bone diseases. - Drugs and diseases that may affect platelet count or function.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Platelet rich fibrin (PRF)
following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound
Advanced platelet rich fibrin (A-PRF)
following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound
blood clot
following atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound

Locations

Country Name City State
Egypt School of dentistry , Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in bucco-lingual dimensions clinical measurement using bone caliper in mm numerical 6 months
Secondary change in alveolar bone height radiographic measurement using CBCT in mm numerical 6 months
Secondary bone dentistry radiographic measurement using CBCT 6 months
Secondary soft tissue healing clinical measurement using landr et al index (healing index) in numerical 6 months
Secondary postoperative pain scores clinical measurement using VAS scale in numerical where No pain (0-4 mm) - mild pain (5-44 mm) -moderate pain (45-74 mm), and severe pain (75- 100 mm). 2 weeks
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