Clinical trial NCT06244797: Investigation of the Effects of H-PRF on the Period After Impacted Third Molar Tooth Extraction
Official title: Investigation of the Effects of Y-TZF (Horizontal Platelet-Rich Fibrin) on the Period After Impacted Third Molar Tooth Extraction: Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: Impacted Third Molar Tooth, PRF
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: After wisdom teeth are extracted, the patient may have some complaints in the post-operative period. Pain, swelling and edema are some of them. These inflammatory complications are important for patients and surgeons to reduce the risk of complications and ensure postoperative recovery and develop customized strategy. Many studies have been conducted in the literature to minimize these situations encountered after tooth extraction.

Detailed description: Many studies have been conducted in the literature to minimize these situations encountered after tooth extraction. Various regenerative methods are being developed to reduce these complaints of patients. Regenerative treatments include non-steroidal anti-inflammatory drugs (NSAIDs), laser therapy, steroids, ultrasound, and PRF applications.

PRF(platelet-rich fibrin) application placed in the extraction socket is one of the regenerative methods used to reduce these complaints. PRF has a fibrin structure obtained from natural blood tissue, containing abundant platelets and leukocytes. This fibrin matrix contains various growth factors and cytokines, including growth factor-beta1 (TGF-β1), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), interleukin (IL), as well as platelets and leukocytes. These factors act directly on promoting the proliferation and differentiation of osteoblasts, endothelial cells, chondrocytes, and various fibroblast sources.

It is known that PRF has a beneficial effect in relieving pain and swelling and reducing the incidence of alveolar osteitis after extraction of an impacted lower third molar. Therefore, it is placed in extraction sockets to try to reduce post-operative complications.

PRF applications are also developing in their own right, and one of them is the H-PRF (horizontal PRF) application. Recently, horizontal centrifugation of PRF has been shown to provide better cell layer separation and minimize cell accumulation that prevents uniform cell layer formation on the distal surfaces of centrifuge tubes.

Eligibility criteria: Inclusion Criteria:

* Volunteer ASA I individuals between the ages of 18-40

Exclusion Criteria:

* Those who are pregnant or lactating
* Those receiving anticoagulant or antiplatelet drug therapy
* Those who received radiotherapy to the head and face area
* Those who are allergic to local anesthetics and prescribed medications

Primary outcomes:
measure: Evaluation of edema
timeFrame: 7 days
measure: Assessment of pain:
timeFrame: 7 days
measure: Evaluation of soft tissue:
timeFrame: 7 days
measure: Evaluation of maximum mouth opening:
timeFrame: 7 days
Secondary outcomes:
measure: Assessment of Quality of Life
timeFrame: 7 days
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa Üniversitesi
state: Kaleardı Neighbourhood
Study officials:
affiliation: Tokat Gaziosmanpasa University
name: Esengül ŞEN
role: STUDY_DIRECTOR
References:
citation: Majid OW. Submucosal dexamethasone injection improves quality of life measures after third molar surgery: a comparative study. J Oral Maxillofac Surg. 2011 Sep;69(9):2289-97. doi: 10.1016/j.joms.2011.01.037. Epub 2011 Apr 22.
citation: Landry RG, Turnbull RS, Howley T: Effectiveness of benzydamyne HCl in the treatment of periodontal post- surgical patients. Res Clin Forums. 1988, 10:105-18