Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery

Study Overview
=================
Brief Summary
-----------------
A Randomized, controlled clinical trial and split-mouth design was performed to assess and compare the effect of platelet-rich fibrin (PRF) on soft tissue healing, periodontal pocket depth and alveolar bone height distal to second molar of the study and control groups after third molar surgical removal. Sample include of participants who had indication of impacted lower third molars extraction on both sides with symmetrically orientation and same difficult index. All participants had same extraction protocol on both side at Department of Oral surgery, Faculty of Odonto-stomatology, University of Medicine and Pharmacy, Ho Chi Minh City. Soft tissue healing, periodontal pocket depth and distal bone height were evaluation by an independent investigator.

Official Title
-----------------
Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery

Conditions
-----------------
Platelet-rich Fibrin

Intervention / Treatment
-----------------
* Other: PRF
* Other: standard third molar surgical removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old. Good general health. Bilateral lower third molars equivalent in inclination and Pell and Gregory's impaction classification (classification II, III and B, C). The assessment of equivalence between two mandibular third molars was determined on the panoramic radiograph. The difference of third molar inclination on both sides not greater than 15 degrees. The patient consented to participate in the study after hearing clearly the explanation of purposes and requirements of the study. Exclusion Criteria: Patients with any systemic disease contraindicated for surgery. Presence of acute inflammation or infection at third molar areas. Patients refused to participate in the study, did not comply with treatment or did not come to the follow-up examination as required. The difference in surgical time between the two groups was more than 10 minutes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: split-mouth study, 1 side would be the study side and other side would be control side
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy | Other: standard third molar surgical removal<br>* standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy<br>|
| Experimental: PRF<br>PRF was applied in third molar socket after removal following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy | Other: PRF<br>* centrifuge patient's blood to collect 1 block of yellowish condensed fibrin, which is platelet-rich fibrin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periodontal pocket depth | periodontal pocket depth at distal buccal and distal lingual side of second molar | 1rst postoperative month | 
| periodontal pocket depth | periodontal pocket depth at distal buccal and distal lingual side of second molar | 3rst postoperative month | 
| periodontal pocket depth | periodontal pocket depth at distal buccal and distal lingual side of second molar | 6rst postoperative month | 
| distal bone resorption | resorption of alveolar bone height distal to second molar | 3rd postoperative month | 
| distal bone resorption | resorption of alveolar bone height distal to second molar | 6th postoperative month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| soft tissue healing index | soft tissue healing around third molar socket | 3rd postoperative day | 
| soft tissue healing index | soft tissue healing around third molar socket | 7th postoperative day |