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Clinical Trials/NCT03703479
NCT03703479
Completed
N/A

The Effect of Advanced Platelet Rich Fibrin in Alveolar Defect After Removal of Bilateral Mandibular Third Molar

King Abdulaziz University1 site in 1 country10 target enrollmentOctober 20, 2018
ConditionsWound Heal

Overview

Phase
N/A
Intervention
Not specified
Conditions
Wound Heal
Sponsor
King Abdulaziz University
Enrollment
10
Locations
1
Primary Endpoint
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)
Status
Completed
Last Updated
7 years ago

Overview

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.

Detailed Description

This is a randomized double-blind clinical study. A preoperative and radiographic evaluation will be done in order to select the patients. Inclusion criteria are healthy patients above 18 years old with vertical or mesioangular bilateral impacted mandibular third molars. Exclusion criteria are missing second molars or indicated for extraction (un-restorable and remaining roots), patients under immunosuppressant and patients with acute infection. Those who fail to attend for follow-up appointments will be excluded. The probing depth (PD) and clinical attachment level (CAL) distal to the second molar will be measured before each procedure. All patients will undergo bilateral removal of 3rd molar in a single appointment. Envelope flap with distal extension and a full-thickness mucoperiosteal flap will be utilized and the teeth will be removed with elevators. Bone removal will be utilized if needed. Following the extraction, venous blood will be withdrawn to fill 2 tubes of 10mL each (sterile vacuum plain tube for A-PRF™ +). The blood tubes will be spun in the centrifugation machine for 13 minutes at 1300 rpm then it is pressed in PRF Box to form PRF clots which will be placed in one the extraction socket while the other socket will not receive a PRF (control).Randomization will be done using a coin toss. Both extraction cavities will be closed using 3-4 interrupted sutures using 3.0 chromic gut sutures. Postoperatively, all patients will be treated with oral antibiotic amoxicillin 500 mg and non-steroidal anti-inflammatory medications ibuprofen 600mg in case. also, all patients will be instructed to rinse with 0.2 % Chlorhexidine mouthwash for seven days postoperative. On the 7th,15th and 90th days, patients will be asked about pain using visual analog scale (VAS) and whether they have any concern related to extraction socket statuses like halitosis, empty socket, open socket, dehiscence, and infection signs including swelling, pus, or fever. They will also undergo a clinical examination at this visit and the consecutive visits. The following measures will be assessed during each clinical examination: the presence of a pocket distal to the adjacent second molar measuring the pocket depth and clinical attachment level and any signs of infection. Data will be analyzed using statistical software. Analysis of multivariate regression will be used. The healing status will be compared between the graft site and the control site. Results will be interpreted to be statistically significant if they have a P-value of less than 0.05

Registry
clinicaltrials.gov
Start Date
October 20, 2018
End Date
March 24, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

talal zahid

Assistant professor

King Abdulaziz University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Pain reported by the patient according to the visual analogue scale (VAS)(7 days after the extraction)

Study Sites (1)

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