Pain After Removal of Mandibular Third Molars With or Without Advanced Platelet-rich Fibrin

NCT06377839 | Recruiting Early Phase 1

• 1 other identifier: N-20230048
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is the most common complication following surgical removal of an impacted mandibular third molar. Several risk factors may increase the intensity and duration of pain following removal of mandibular third molars. Acute postoperative pain can transcript into postoperative chronic pain without an explainable reason or a specific risk factor. The use of advanced platelet-rich fibrin in the extraction socket following surgical removal of mandibular third molar have diminished the intensity and duration of acute postoperative pain and facilitated improved wound healing. The objective of the present study is therefore to identified specific risk factors and predictors for developing postoperative chronic pain following surgical removal of mandibular third molars with or without advanced platelet-rich fibrin applied in the extraction socket using epigenetic modulation.

Conditions

Pain Syndrome

Keywords

Pain, surgery, quality of life,

Outcome Measures

Primary Outcomes (1)

• Assessment of postoperative pain by using Visual Analoque scale

  Measurements of pain using Visual Analogue Scale (0 is no pain and 100 is the worst pain), so lower score is a better outcome

  Postoperative (15 days)

Secondary Outcomes (1)

• Assessment of quality of life

  Pre- and postoperative (1-year)

Study Arms (2)

With advanced platelet-rich fibrin in the ekstraction socket

ACTIVE COMPARATOR

Right or left side of the mandible

Biological: Advanced platelet-rich fibrin in the ekstraction socket

Without advanced platelet-rich fibrin in the ekstraction socket

PLACEBO COMPARATOR

Right or left side of the mandible

Biological: Advanced platelet-rich fibrin in the ekstraction socket

Interventions

Advanced platelet-rich fibrin in the ekstraction socket BIOLOGICAL

Advanced platelet-rich fibrin is a centrifuged fibrin matrix composed of concentrated growth factors, platelet cytokines, and blood cells, which possesses the ability to stimulate wound healing and tissue regeneration. Advanced platelet-rich fibrin is manufacturing from a blood sample.

With advanced platelet-rich fibrin in the ekstraction socket; Without advanced platelet-rich fibrin in the ekstraction socket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Presence of a semi- or fully impacted mandibular third molar.
• Indication for surgical removal of mandibular third molar.

You may not qualify if:

• Patients suffering from chronic pain syndrome.
• Patients in need of daily analgetic.
• Pregnancy.
• Psychiatric problems or unrealistic expectations.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Department of Oral and Maxillofacial surgery, Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Somatoform Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant surgeon, DDS, PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 22, 2024
• Study Start: January 10, 2024
• Primary Completion: April 17, 2024
• Study Completion: December 1, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)