NCT05563519

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2.8 years

First QC Date

February 14, 2022

Last Update Submit

August 20, 2023

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (14)

  • Blood Pressure Evaluation

    Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.

    Preoperative

  • Blood Pressure Evaluation

    Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.

    Right after the surgery

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

I-PRF + collagen

ACTIVE COMPARATOR

I-PRF will be applied with type 1 collagen to the extraction socket after the wisdom tooth operation.

Procedure: I-PRF with collagen

L-PRF

ACTIVE COMPARATOR

Only L-PRF will be applied to the extraction socket after the wisdom tooth operation

Procedure: L-PRF

Interventions

I-PRF with collagenPROCEDURE

The products will be applied to the sockets after tooth extractions

I-PRF + collagen
L-PRFPROCEDURE

The products will be applied to the sockets after tooth extractions

L-PRF

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Interventions

proliferation regulatory factors, human urineCollagen

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Levent Ciğerim, Assoc.Prof.

    Van Yuzuncu Yil University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Oral and Maxillofacial Surgery Department

Study Record Dates

First Submitted

February 14, 2022

First Posted

October 3, 2022

Study Start

January 15, 2021

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)