The aim of this study is to evaluate the analgesic effects of LLLT on maxillary and mandibular block pre-injection sites in patients scheduled for elective third molar removal.
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Heart rate and galvanic skin response (sweat secretion) response.
Secondary outcome
Short questionnaire before the start of treatment and 2 questions after
completion.
Background summary
Removal of wisdom teeth is a routine procedure in oral and maxillofacial
surgery. [1] Generally, removal of third molars is a treatment for impacted
teeth or teeth that fail to erupt during the normal course of growth and
development. Moreover, depending on the anatomically available space on the
dental arches and the fate of the erupting element, another rationale for
removing third molars before complete root formation is to prevent the
likelihood of nerve damage and other oral complications, and maintenance of
adequate orthodontic dental alignment.
Pain control, is necessary during removal of third molars and this is
established by injecting a local anesthetic. The injection itself can be
painful, and topical anesthesia before local anesthesia might influence the
pain during needle penetration and infiltration injection. Topically applied
local anesthetics only provide an anesthetic effect on the mucosal epithelial
surface and does not blunt the effects of discomfort perceived by the patients
related to both needle infiltration and tissue displacement by the anesthetic
fluid load in the anatomical cross-sectional plain. However, refining the
experience of preoperative preparation by reducing additional pharmacological
usage has the advantage that patients with dental fears and anxiety can feel
more at ease and project a serene attitude towards either periodic visits to
their dentist or facilitating important decisions regarding maxillofacial
procedures with confidence.
Concern about pain and anxiety associated with needles dominates preferences
for dental anesthesia; the overwhelming preference for a non-injectable
anesthetic reveals a strong clinical need for alternatives. A conservative
pharmacological approach towards pre-injection management of local anesthesia
could promote both metabolic stability in the tissue intended for treatment, by
endorsing swift postoperative tissue recovery and stabilization, and
eliminating unpleasant tastes associated with topical anesthetics. An
alternative to topical agents may lie in harnessing the beneficial effects
derived from light energy. Low-level laser/light therapy (LLLT) is the
application of light, in the form of either a low power laser or light-emitting
diodes (LEDs), [2] to promote tissue repair and regeneration, [3-6] reduce
inflammation, and induce analgesia. [7-12] Unlike other laser-mediated
treatments, LLLT is not an ablating or heat-based therapy; it is more akin to
photosynthesis. Current knowledge of clinical applications of LLLT in dentistry
is limited, but its applications are well documented for musculoskeletal
applications. [13-16] Pain control in dentomaxillofacial perioperative settings
has focused primarily on the effects of LLLT in postoperative pain management
associated with premolar and third molar extractions. [17-20] Frustratingly, a
consensus on reporting light-related parameters does not exist, which makes it
very difficult to reproduce results that can be used to harness the benefits of
LLLT clinically. [21] Research addressing acute pain management effects remain
unexplored as they apply to light therapy in daily routine dental practice.
[22] Additionally, interests based on drug-free analgesic management in
dentistry and oral medicine have already begun to yield interesting studies
focusing on pain management and healing associated with orthodontic and
periodontal treatments by LLLT. [23-25] We propose to assess the effects of
LLLT on injection sites before local anesthetic injections are administered to
determine if the patient experiences any laser induced analgesic effects. For
clarity we wish to assert that this research protocol will not bring any
discomfort to the participant, will not intervene with the standard care
protocols associated with third molar extraction procedures, does not aim to
address any queries associated with specific disease or health issues, and
finally local infiltration anesthetic injections will be administered after
LLLT as this is standard operating procedures for surgical removal of third
molars.
Study objective
The aim of this study is to evaluate the analgesic effects of LLLT on maxillary
and mandibular block pre-injection sites in patients scheduled for elective
third molar removal.
Study design
A double-blind randomized study with a control group (RCT).
Study burden and risks
Besides the treatment the patient will undergo, there are no risks associated
with this study and the participants will only be burdened with answering a
short questionnaire. Administering LLLT and filling-in the questionnaire will
take on average only between 10-15 min.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
-Patients referred to the Department of Oral & Maxillofacial Surgery of the Amstelland Hospital (Ziekenhuis Amstelland) for extraction of third molars
-Patients with no previous history of oral diseases
-Patients with an ASA Score 1 or 2 (excluding pregnancy)
-Patients that signed an informed consent form
-Patients >= 18 years
Exclusion criteria
-Patients with a previous history of oral disease
-Patients that did not sign an informed consent form
-Patients with an ASA Score 3 or higher
-Patients < 18 years
Design
Recruitment
Medical products/devices used
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In other registers
Register | ID |
---|---|
CCMO | NL46371.018.14 |