Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05017064 |
| Other study ID # |
119S397-2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 19, 2021 |
| Est. completion date |
September 19, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to evaluate the effects of intraoral cryotherapy on the inflammatory
cytokine levels during root canal treatment and postoperative pain intensity and incidence.
Mandibular premolar teeth of 30 patients diagnosed with asymptomatic apical periodontitis
will be included to the study for this purpose. The experimental protocols consist clinical
and laboratory phases. In clinical phase, procedures of cryotherapy and control groups will
be applied in 2-visit-root canal treatment. The samples, which were collected during root
canal treatment, will be subjected to enzyme-linked immunosorbent assay (ELISA) analysis in
laboratory. Levels of interleukin and inflammatory destructive enzymes will be determined in
collected samples. During the analysis of visual analogue scale scores, the correlation
between the changes of the cytokine and proteolytic enzyme levels and presence and intensity
of pain will be evaluated.
Description:
Cryotherapy is the reduction of the temperature of living tissues for therapeutic purposes.
The temperature decrease that will occur as a result of cryotherapy depends on the degree of
the applied tissue and agent, the application time, and the thermal permeability of the
tissues and the agent . With the application of cryotherapy in human tissues, it is aimed to
reduce the temperature of the host cells and control pain.
There is limited data on the use of cryotherapy, which is widely used in medicine, in the
field of operative dentistry. It is frequently used after surgical procedures such as
cryotherapy, periodontal surgery, tooth extraction and implant application, but its first use
in endodontics is to extend the cold saline solution of during root canal treatment. It has
been described in laboratory studies that it reduces the external temperature of the root by
applying it with apical negative pressure irrigation system for 5 minutes following the
procedures. Following this in vitro study, the efficacy of different cryotherapy protocols in
reducing pain after root canal treatment was reported by all of the few clinical studies.
Studies reported that after endodontic treatment of teeth with symptomatic apical
periodontitis, pain severity decreased after cryotherapy application and the frequency of
postoperative painkiller use of patients decreased. It was reported that cryotherapy
application in endodontic treatments of teeth with symptomatic irreversible pulpitis with
vital pulp reduced postoperative pain severity. A laboratory study performed on extracted
teeth reported that cryotherapy application reduces the vertical fracture strength of the
roots, however, comprehensive laboratory and clinical studies evaluating the various physical
properties of the teeth are required in order to make definitive interpretations concerning
the clinic and to create a consensus.It has not been fully revealed how and by what mechanism
intra-canal cryotherapy applications reduce pain. When cold is applied, a decrease in blood
flow occurs in living tissues; It has been shown that neural receptors are inhibited in skin
and subcutaneous tissues. Clinical studies report that cold therapy reduces acute
musculoskeletal pain, muscle spasms, connective tissue strains, nerve conduction time, and
hemorrhage. Cryotherapy restricts the inflammatory reactions that occur in the damaged area
by causing vasoconstriction and inhibition of cellular metabolism. Vasoconstriction thus
causes a decrease in edema and blockage of nerve endings with the decrease in temperature
leads to a decrease in pain. Although decreasing body temperature also decreases peripheral
nerve conduction, when it falls below 15 ° C, nerve conduction is completely deactivated.
Tissue damage that may result from secondary hypoxia is also minimized by slowing down cell
metabolism. The activities and amounts of destructive enzymes in the tissue are reduced. The
analgesic effect of cryotherapy is achieved by a combination of reducing the chemical
mediators of pain and slowing down neural pain signals. In addition, a 50% slowdown in
metabolism has a positive effect on oxygen diffusion in damaged tissues. How intra-canal
cryotherapy reduces postoperative endodontic pain has not been fully elucidated yet. When the
effects of cryotherapy applications on damaged muscle and connective tissues are interpreted,
a decrease in the amount of inflammatory cytokines is expected in a region where cryotherapy
is applied. The amounts of inflammatory cytokines and destructive enzymes in periradicular
tissues were not evaluated after intra-canal cryotherapy.
Intra-canal cryotherapy stands out as a simple, economical and non-toxic pain control
technique, although it eliminates the side effects that may be caused by drugs by reducing
the use of painkillers after the procedure. It is a technique that should be applied rather
than an alternative, especially for patients who are recommended to avoid painkiller use
(drug allergy, geriatric population). It consists of washing the root canals with cold saline
solution for 5 minutes, which can be easily adapted to the endodontic treatment routine. This
procedure can be applied with negative pressure irrigation systems or endodontic irrigation
needles used in routine irrigation. It is a more practical and controlled procedure than
applying an ice pack inside or outside the mouth after the procedure, and it will be applied
by the physician.
