Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06377839 |
| Other study ID # |
N-20230048 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2024 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Aalborg University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Pain is the most common complication following surgical removal of an impacted mandibular
third molar (SRM3). Acute postoperative pain (APP) following SRM3 is a normal physiological
response to the tissue damage and usually treated sufficiently by paracetamol, non-steroidal
anti-inflammatory drugs, or opioids. Increasing age, gender, smoking habit, length of
surgery, type of anesthesia, intraoperative complications, surgeon's experience, and
contamination of the surgical wound are well-known risk factors that affects the intensity
and duration of APP. However, APP can transcript into postoperative chronic pain (PCP)
without an explainable reason or a specific risk factor. Moreover, specific predictors for
development of PCP following SRM3 is currently not sufficiently elucidated.
PCP is defined as pain lasting for two months or more after surgery, when other causes of
pain are excluded. The characteristics and intensity of PCP varies among individuals and
specific factors for developing PCP has not yet been clearly elucidated. PCP leads to severe
functional limitations and impaired oral health-related quality of life (OHRQoL). The
presence of pain prior to surgery as well as the intensity and duration of APP are considered
as critical predictors for developing PCP. Various pharmacological and preventive strategies
have therefore been proposed to minimize the risk of APP following SRM3 including
modification of the surgical technique, sufficient intra- and postoperative pain control as
well as preoperative psychological intervention focusing on the psychosocial and cognitive
risk factors. Moreover, risk factors, such as genetic and epigenetic modifications have also
been associated with APP and PCP. Among epigenetic modifications, non-coding RNAs have shown
to be associated with the development of PCP. However, clarification of factors that
specifically influence the development of PCP following SRM3 remains unknown.
Advanced platelet-rich fibrin (APRF) 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. Manufacturing of APRF from blood samples and
application of APRF in the extraction socket following SRM3 have diminished the intensity and
duration of APP and facilitated improved wound healing, as reported in systematic reviews and
meta-analyses. Application of APRF in the extraction socket following SRM3 possess therefore
the ability to minimize the risk of developing PCP due to a shorter period of APP.
The objective of the present study is therefore to identified specific predictors for
developing PCP following SRM3. Eighty patients with an impacted mandibular third molar will
be randomly allocated to SRM3 with or without application of APRF in the extraction socket. A
standardized postoperative pain-management regime will be applied following SRM3. Blood
samples (80mL) will be obtained intraoperative and one week postoperatively for all included
patients. The investigated non-coding RNAs in the blood of participants will be used to
assess their association with pain sensitivity and risk of developing PCP. Self-administrated
questionnaires and visual analogue scale (VAS) will be used to correlate the results of the
of non-coding RNA dysregulation with the duration and intensity of postoperative pain, social
and working isolation, physical appearance, eating and speaking ability, diet variations,
sleep impairment, and discomfort after one week, one month, and one year, respectively. The
Modified Dental Anxiety Scale is used to measure preoperatively dental anxiety. OHRQoL is
evaluated by self-administrated questionnaires obtained preoperatively and compared with
postoperative assessment after one week, one month, and one year. The primary outcome measure
is intensity and duration of postoperative pain following SRM3 with or without application of
APRF in the extraction socket. These results will be correlated with alteration in non-coding
RNAs expression to identified possible predictors for developing PCP. The results will be
published in international peer-reviewed journals as well as presented at congresses.
