NCT03703479

Brief Summary

To evaluate the healing effect of advanced platelet-rich fibrin (blood clot charged with growth factors) taken from the patient own blood on the extraction site.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 8, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

October 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

October 8, 2018

Last Update Submit

March 26, 2019

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)

    Periodontal healing is evaluated based on changes in clinical attachment loss (mm)

    At baseline and at follow-up 4 weeks and 12 weeks after extraction

Secondary Outcomes (1)

  • Pain reported by the patient according to the visual analogue scale (VAS)

    7 days after the extraction

Study Arms (2)

A-PRF group

EXPERIMENTAL

Socket site that will receive A-PRF clot

Other: autologous blood clot made from the patient own clot without any additive

control

NO INTERVENTION

socket site that will not receive any intervention

Interventions

autologous blood clot made from the patient own clot without any additiveOTHER

advanced Platelet-rich fibrin clot is made from venous blood withdrawn from the patient

A-PRF group

Eligibility Criteria

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

You may qualify if:

  • Healthy patients above 18 years old with mirror image vertical or mesioangular bilateral impacted mandibular third molars

You may not qualify if:

  • Missing second molars or indicated for extraction (un-restorable and remaining roots).
  • Patients under immunosuppressant and patients with acute infection.
  • Patients who fail to attend for follow-up appointments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdul Aziz University

Jeddah, Mecca Region, 21589, Saudi Arabia

Location

Related Publications (1)

  • Zahid TM, Nadershah M. Effect of Advanced Platelet-rich Fibrin on Wound Healing after Third Molar Extraction: A Split-mouth Randomized Double-blind Study. J Contemp Dent Pract. 2019 Oct 1;20(10):1164-1170.

    PMID: 31883251DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: spilt mouth design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 12, 2018

Study Start

October 20, 2018

Primary Completion

February 20, 2019

Study Completion

March 24, 2019

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

SA(1)