Comparison of the Efficacy of I-Prf Impregnated Collagen and L-Prf on Healing After Impacted Third Molar Surgery

Impacted Third Molar Tooth Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05563519
• Other study ID #: 25.12.2020/01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2023
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Procedure:
• I-PRF with collagen
The products will be applied to the sockets after tooth extractions
• L-PRF
The products will be applied to the sockets after tooth extractions

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University, Faculty of Dentistry	Van	Tusba

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Evaluation	Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.	Preoperative
Primary	Blood Pressure Evaluation	Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.	Right after the surgery
Primary	Pain Evaluation	Patients will requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 2nd day
Primary	Pain Evaluation	Patients will requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 7th day
Primary	Pain Evaluation	Patients will requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 14th day
Primary	Pain Evaluation	Patients will requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 28th day
Primary	Trismus Evaluation	Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 2nd day
Primary	Trismus Evaluation	Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 7th day
Primary	Trismus Evaluation	Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 14th day
Primary	Trismus Evaluation	Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 28th day
Primary	Edema Evaluation	Postoperative edema will evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion, tragus) which was measured with using thread and millimeter ruler.	Postoperative 2nd day
Primary	Edema Evaluation	Postoperative edema will evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion, tragus) which was measured with using thread and millimeter ruler.	Postoperative 7th day
Primary	Edema Evaluation	Postoperative edema will evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion, tragus) which was measured with using thread and millimeter ruler.	Postoperative 14th day
Primary	Edema Evaluation	Postoperative edema will evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion, tragus) which was measured with using thread and millimeter ruler.	Postoperative 28th day