The aim of this study is to assess the influence of alveolar tampon packing on incidence of pain, swelling, trismus, alveolar osteitis, and QoL in the week following M3 surgery.
ID
Source
Brief title
Condition
- Other condition
- Head and neck therapeutic procedures
Synonym
Health condition
dental extractions, post-interventional recovery
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative pain measurements (VAS scores, 11-points NRS) and quality of life
(QoL) evaluations with OHIP-14 questionnaires.
Secondary outcome
Postoperative infection and alveolaire osteitis (AO).
Background summary
Third molar (M3) removal is among the most common surgical procedures performed
annually in the Netherlands and represents a major proportion of the outpatient
surgical procedures performed by oral and maxillofacial surgeons (OMFS). As
such, numerous studies have been devoted to evaluate all aspects of M3 surgery,
including indications for removal, radiographic analyses for surgical planning,
estimates of difficulty and risk factors for difficulty, as well as
complications by rate and type. Studies devoted to complications have garnered
significant attention, due to the fact that a large volume of cases results in
significant numbers of complications, even though the overall incidence remains
relatively low. The complications and costs associated with the removal of
unerupted or partially erupted third molars are considerable and the routine
prophylactic removal of all impacted wisdom teeth has become unacceptable. The
criteria for surgical intervention in literature are recurrent pericoronitis,
caries not amenable to restorative measures, dentigerous cyst, internal or
external resorption, and periodontal disease to which the M3 is contributing
(criteria produced by the National Institute of Clinical Excellence (NICE) in
the United Kingdom). Wisdom teeth in a fracture line and those who require
removal as part of an orthodontic treatment plan are included in the criteria
for removal.
Postoperative pain, swelling, and trismus are almost universal and many studies
report overall complication rates for M3 surgeries close to approximately 20%,
with most complications occurring postoperatively. Although these data suggest
that 1:5 patients will experience a complication, care should be taken not to
overestimate the risk to patients from M3 removal. Among the intraoperative
complications, few patients experience what would be considered serious,
debilitating complications requiring further treatment (e.g., nerve injuries,
jaw fractures). The largest proportion of postoperative complications (45.3%)
is due to alveolar osteitis (AO), a well-known complication with identifiable
risk factors and well-established clinical management protocols. However, the
frequent complications in M3 surgery can have a significant impact on the
patient*s postoperative quality of life (QoL). The sensation of pain is of
course subjective and there are no uniform criteria for its measurement. Pain
sensation depends on each individual*s subjective pain threshold, which may be
influenced by diverse factors including age, gender, anxiety, and surgical
difficulty.
QoL has become a widely known concept and has been studied in many research
fields. Numerous QoL measures have been constructed, many are health related.
The recognition of health as a fundamental factor in ones QoL has led to the
usage of subjective measures instead of clinical indicators. Thus ones personal
perspective of the impact of health on QoL became increasingly important. Among
these instruments is the Oral Health Impact Profile (OHIP-49), developed by
Slade and Spencer in 1994. The OHIP-49 and its shorter derivative, the OHIP-14,
have been given a great deal of attention and are among the most extensively
used instruments in dental research. Both instruments are frequently applied in
cross-sectional and longitudinal studies and are aimed to evaluate the
physical, psychological, and social impacts of oral health on people*s QoL.
Earlier studies have confirmed the suitability of the OHIP-14 questionnaires
after M3 surgery.
Study objective
The aim of this study is to assess the influence of alveolar tampon packing on
incidence of pain, swelling, trismus, alveolar osteitis, and QoL in the week
following M3 surgery.
Study design
Single-center prospective comparative study using a crossover design in which
eligible subjects will be assigned to surgical removal of an impacted wisdom
tooth in the lower jaw with a tampon and surgical removal of a wisdom tooth
without a tampon.
Intervention
After surgical removal of the mandibular third molar, the patients will receive
on one side postoperative treatment with a tampon and the contralateral side
will be treated without a tampon (or vice versa).
Study burden and risks
The use of tampons is used a lot by clinicians, however the postoperative
effects have never been well researched. There are no negative effects
associated with postoperative recovery. The assumed advantages are reduction in
postoperative pain and wound infection.
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 only impacted mandibular M3 requiring an ostectomy
- Patients who are going to have bilateral mandibular M3 surgery
- Patients without previous history of oral disease, free of periodontal disease, no discernable active
pathology associated with the M3, and without acute pericoronitis
- Patients that signed an informed consent form
- Patients >=18 years of age
Exclusion criteria
- Patients with a previous history of periodontal disease or local pathology (e.g. cysts or tumors)
associated with the M3s
- Patients with ibuprofen allergy
- Patients with iodine allergy
- Patients with known medical history of renal failure, blood dyscrasia or chronic liver disease of any
type, uncontrolled diabetes mellitus, HIV infection,
- Patients with a history of recent and/or symptomatic peptic ulcer
- Patients on anticoagulants or corticosteroids prior (< 15 days) to entry into this study
- Pregnant or lactating female patients
- Patients with recent local infection prior to surgery (< 15 days)
- Patients with previous radiation therapy to the maxillofacial region
- Organ or marrow transplant candidates or recipients
- Patients requiring antibiotic prophylaxis for endocarditis
- Patients that did not sign an informed consent form
- Patients < 18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52968.018.15 |