Clinical trial NCT05563519: Comparison of the Efficacy of I-Prf Impregnated Collagen and L-Prf on Healing After Impacted Third Molar Surgery
Official title: Comparison of I-Prf Impregnated Collagen With L-Prf in Terms of Postoperative Complications and Wound Healing After Lower Impacted Third Molar Teeth Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Impacted Third Molar Tooth
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Fifty patients were included for the randomized, prospective, split mouth and single-blind study. Two groups were formed in the study. The lower right and lower left wisdom teeth of the patients with extraction indication for lower impacted wisdom teeth were included in separate groups. In the first group (on one side of the same patients), leukocyte platelet-rich fibrin (L-PRF, 2700rpm,12 min) was obtained after lower impacted wisdom tooth surgery, applied into the socket and sutured. The other tooth of the patient was operated 5 weeks after the operation of the region included in the first group. In the second group (to the other side of the same patient), injectable platelet-rich fibrin (I-PRF, 700rpm, 3min) was obtained and 1\*2 cm type 1 collagen plug (ACE RCP, Resorbable Collagen Plug, Collagen Matrix, Inc. Oakland, New Jersey) USA)) was impregnated and applied into the socket as such. It was followed for 4 weeks.
Primary purpose: PREVENTION

Brief summary: Impacted third molar extraction is a very common surgical intervention. Post-procedure pain causes various post-operative changes such as edema and trismus. Minimizing these changes will enable patients to overcome the post-operative process more easily. In this study, it was aimed to compare the possible effects of I-PRF (Impregnated Platelet Rich Fibrin) type 1 collagen with L-PRF (Leukocyte Platelet Rich Fibrin) on postoperative complications and wound healing after lower impacted wisdom tooth surgery. There are studies in the literature showing that very different treatment methods are used for buried twenty-year-old surgery. However, although there are studies in which intra-socket L-PRF, I-PRF, and collagen plugs are applied, there is no accepted standard for comparing the effects of L-PRF and I-PRF impregnated type-1 collagen with each other or for postoperative comfort. The aim of the study is to observe the effect of 2 different techniques on postoperative complications and possible changes in wound healing and discuss whether there is a difference and the effective one.

Detailed description: Fifty patients were included for the randomized, prospective, split mouth and single-blind study. Two groups were formed in the study. The lower right and lower left wisdom teeth of the patients with extraction indication for lower impacted wisdom teeth were included in separate groups. In the first group (on one side of the same patients), leukocyte platelet-rich fibrin (L-PRF, 2700rpm,12 min) was obtained after lower impacted wisdom tooth surgery, applied into the socket and sutured. The other tooth of the patient was operated 5 weeks after the operation of the region included in the first group. In the second group (to the other side of the same patient), injectable platelet-rich fibrin (I-PRF, 700rpm, 3min) was obtained and 1\*2 cm type 1 collagen plug (ACE RCP(Resorbable Collagen Plug), Resorbable Collagen Plug, Collagen Matrix, Inc. Oakland, New Jersey, USA) was impregnated and applied into the socket as such. It was followed for 4 weeks. Both surgical sites were sutured with 4\\0 silk sutures (18mm, 3\\8 sharp, 75cm black suture). It was determined randomly which material would be used first on which side.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 years and over,
* Patients with semi-impacted or fully impacted wisdom teeth,
* Patients without systemic disease (According to ASA(The American Society of Anesthesiologists) classification, ASA1 individuals),
* Individuals who did not use any medication in the last two weeks.

Exclusion Criteria:

* Individuals with painful temporomandibular joint disease,
* Internal irregularity and/or inflammatory joint disease with a mouth opening of less than 25 mm,
* Pregnant and lactating individuals,
* Individuals who do not come to their postoperative controls,
* Individuals using different drugs other than those recommended,
* Individuals who are allergic to the study drugs and materials.

Primary outcomes:
measure: Blood Pressure Evaluation
timeFrame: Preoperative
measure: Blood Pressure Evaluation
timeFrame: Right after the surgery
measure: Pain Evaluation
timeFrame: Postoperative 2nd day
measure: Pain Evaluation
timeFrame: Postoperative 7th day
measure: Pain Evaluation
timeFrame: Postoperative 14th day
measure: Pain Evaluation
timeFrame: Postoperative 28th day
measure: Trismus Evaluation
timeFrame: Postoperative 2nd day
measure: Trismus Evaluation
timeFrame: Postoperative 7th day
measure: Trismus Evaluation
timeFrame: Postoperative 14th day
measure: Trismus Evaluation
timeFrame: Postoperative 28th day
measure: Edema Evaluation
timeFrame: Postoperative 2nd day
measure: Edema Evaluation
timeFrame: Postoperative 7th day
measure: Edema Evaluation
timeFrame: Postoperative 14th day
measure: Edema Evaluation
timeFrame: Postoperative 28th day
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University, Faculty of Dentistry
state: Tuşba
Study officials:
affiliation: Van Yuzuncu Yil University, Faculty of Dentistry
name: Levent Ciğerim, Assoc.Prof.
role: STUDY_DIRECTOR
References: