Clinical trial NCT05866965: Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
Official title: Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet-rich Fibrin
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: split-mouth study, 1 side would be the study side and other side would be control side
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: periodontal pocket depth
timeFrame: 1rst postoperative month
measure: periodontal pocket depth
timeFrame: 3rst postoperative month
measure: periodontal pocket depth
timeFrame: 6rst postoperative month
measure: distal bone resorption
timeFrame: 3rd postoperative month
measure: distal bone resorption
timeFrame: 6th postoperative month
Secondary outcomes:
measure: soft tissue healing index
timeFrame: 3rd postoperative day
measure: soft tissue healing index
timeFrame: 7th postoperative day
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University of Medicine and Pharmacy
Study officials:
affiliation: University of Medicine and Pharmacy, Ho Chi Minh city
name: Phong Cu Lam, Master
role: PRINCIPAL_INVESTIGATOR
References: