Sterile versus Aseptic treatment in Dento-Alveolar Surgery*

The costs of health care have increased sharply in the past two decade, from
45 to 116 billion annually in the Netherlands. An uncontrollable rise in
healthcare costs is a burden not only in a financial sense, but also in terms
of sustainability, healthcare uses a lot of raw materials and produces an
exceeding amount of residual waste. The 'Green Deal Sustainable Care' wants to
focus on, among other things, reducing the use of raw materials and products,
and where possible, and aims for a waste reduction of at least 25% in 2026
compared to 2018. However, the question is whether the necessary cost savings
and waste reduction will be achieved. A critical survey of the usual procedures
is therefore necessary.
Within dental practices, non-sterile procedures are mostly applied. Within OMF
surgical care in a hospital setting however, standard procedure are sterile
gloves and materials. The question is whether this contributes to safety of
interventions in a treatment area (the mouth/pharynx) that is not sterile.
Specifically, procedures in the field of dento-alveolar surgery (DA-Surgery) l.
These are relatively low-complexity, high-volume procedures such as removal of
teeth, root remains, wisdom teeth or inflammation. DA surgery in a hospital
setting consists of around 400,000 procedures per year in the Netherlands.
According to protocol, sterile gloves are used for all procedures within MKA
surgery. These are relatively expensive and, because of the packaging per set,
also produce a relatively large amount of residual waste that is difficult to
separate. Nationally, this is estimated to be more than 700,000 pairs of gloves
and 400,000 sterile drape sets on an annual basis. The use of non-sterile
materials can not only result in a significant reduction in costs ( 5-7 times
reduction), but in particular can contribute to the reduction of the amount of
packaging material, raw materials, transport costs and residual waste

The main objective is whether the standard use of non-sterile gloves and/or
drapes can be a safe and a good alternative in dento-alveolar surgery. The
second objective is to determine whether the use of non-sterile gloves or
covering materials is also a good alternative for the practitioner.

The study was designed as a pragmatic, monocenter, prospective, single blinded,
randomized controlled study. The expected duration of the research is 2 years.

The patients are mainly referred by the dentist to the OMFS surgery.
the patient follows the regular protocol:
1. Intake and consultation for dento-alveolar surgery (removal of one or more
teeth). During the consultation, the patient will be extensively informed about
the indication for dento-alveolar surgery, technical aspects and possible
after-effects/complications (standard procedure). In addition, the patient is
informed about the possible participation in this study. Via the my Amphia app,
the patient has already received information prior to this consultation about:
the treatment, the practitioner, postoperative instructions and after-effects.
In addition, information about the purpose of the study and access to the
patient information folder of the study.
2. Depending on the patient's wishes and if the patient has already gone
through the information folder at home, the consultation can be succeed by a
treatment or this can result in an appointment for treatment.
3. If the patient chooses to participate in the study, randomization will take
place to determine in which group (sterile versus aseptic) the patient will be
placed. The patient is not informed in which group he/she has come
(single-blind).
4. If indicated, the patient will receive a follow-up appointment for further
treatment.
5. The patient is given an instruction folder, in which possible postoperative
objections and possible complications are explained. This folder also clearly
explains when the patient should contact us.
6. In case of complaints, the patient will contact the Amphia hospital and not
the referrer (dentist or general practitioner). The post-operative complaints
will be registered in Epic using the standard post-operative complaints module.
7. Postoperatively, the postoperative course will be followed by means of a
digital questionnaire

Sterile versus unsterile gloves/materials

The risk for the patients is very low, given the low expectation of difference
in postoperative infection (based on theory and available literature). If there
is a possible increased risk of postoperative infection, this can usually be
treated well and predictably with incision & drainage and/or antibiotics