Comparison of the Efficacy of I-Prf Impregnated Collagen and L-Prf on Healing After Impacted Third Molar Surgery
Primary Purpose
Impacted Third Molar Tooth
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
I-PRF with collagen
L-PRF
Sponsored by
About this trial
This is an interventional prevention trial for Impacted Third Molar Tooth
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.
Sites / Locations
- Van Yuzuncu Yil University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
I-PRF + collagen
L-PRF
Arm Description
I-PRF will be applied with type 1 collagen to the extraction socket after the wisdom tooth operation.
Only L-PRF will be applied to the extraction socket after the wisdom tooth operation
Outcomes
Primary Outcome Measures
Blood Pressure Evaluation
Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.
Blood Pressure Evaluation
Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05563519
First Posted
February 14, 2022
Last Updated
August 20, 2023
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05563519
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I-PRF + collagen
Arm Type
Active Comparator
Arm Description
I-PRF will be applied with type 1 collagen to the extraction socket after the wisdom tooth operation.
Arm Title
L-PRF
Arm Type
Active Comparator
Arm Description
Only L-PRF will be applied to the extraction socket after the wisdom tooth operation
Intervention Type
Procedure
Intervention Name(s)
I-PRF with collagen
Intervention Description
The products will be applied to the sockets after tooth extractions
Intervention Type
Procedure
Intervention Name(s)
L-PRF
Intervention Description
The products will be applied to the sockets after tooth extractions
Primary Outcome Measure Information:
Title
Blood Pressure Evaluation
Description
Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.
Time Frame
Preoperative
Title
Blood Pressure Evaluation
Description
Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.
Time Frame
Right after the surgery
Title
Pain Evaluation
Description
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).
Time Frame
Postoperative 2nd day
Title
Pain Evaluation
Description
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).
Time Frame
Postoperative 7th day
Title
Pain Evaluation
Description
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).
Time Frame
Postoperative 14th day
Title
Pain Evaluation
Description
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).
Time Frame
Postoperative 28th day
Title
Trismus Evaluation
Description
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.
Time Frame
Postoperative 2nd day
Title
Trismus Evaluation
Description
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.
Time Frame
Postoperative 7th day
Title
Trismus Evaluation
Description
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.
Time Frame
Postoperative 14th day
Title
Trismus Evaluation
Description
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.
Time Frame
Postoperative 28th day
Title
Edema Evaluation
Description
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.
Time Frame
Postoperative 2nd day
Title
Edema Evaluation
Description
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.
Time Frame
Postoperative 7th day
Title
Edema Evaluation
Description
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.
Time Frame
Postoperative 14th day
Title
Edema Evaluation
Description
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.
Time Frame
Postoperative 28th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levent Ciğerim, Assoc.Prof.
Organizational Affiliation
Van Yuzuncu Yil University, Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Van Yuzuncu Yil University, Faculty of Dentistry
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Efficacy of I-Prf Impregnated Collagen and L-Prf on Healing After Impacted Third Molar Surgery
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