Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05845437 |
| Other study ID # |
2023-01379-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Region Skane |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Currently, an ongoing generational shift of the dental community in Sweden originates from an
increased number of retiring dentists. Meanwhile, a declining number of dental professionals
puts a strain on the care system and reduces the availability of dental care to patients in
need of treatment. With fewer experienced dentists, available to guide newly graduated
dentists, an increased number of referrals to specialist care units might be a consequence.
E.g. referrals to oral and maxillofacial departments originating from a need of assistance in
more advanced cases of assessments, treatment planning and therapies. The decreasing number
of dentists is also possible to negatively affect the recruitment to specialized dental
units, which in turn further decreases treatment availability. When the need for dental care
exceeds the capacity of the dental care providers, a possible solution might be to minimize
the number of referrals possible to treat in general dentistry, thus prioritize patients
truly in need of specialist care. Hence, a reduced waiting time and improved accessibility to
an adequate treatment.
The aim of this study is to explore the suitability of referrals concerning exodontia to the
departments of oral and maxillofacial surgery in southern Sweden. The primary objective is to
assess the level of difficulty in referrals on dental extractions. Secondary objectives are
assessments of outcome from treatment and comparison of the suggested treatment of the
referral with the outcome. The hypothesis is that the level of difficulty of the required
treatments in referrals to oral and maxillofacial departments in southern Sweden is low and
constitutes a contributing factor to prolonged waiting queues in specialized dentistry.
Description:
The following study is a retrospective study wherein referral letters sent over the course of
the months of January to December in 2021 to oral and maxillofacial surgery departments in
Lund, Helsingborg and Kristianstad, Sweden will be consecutively collected and reviewed.
After a a total screening of referrals concerning dentoalveolar surgery referrals that are
related to or possibly related to exodontia will be included into the study. Each referral
letter is going to be assessed by the following criteria:
- Patient chief complaint
- Patient's general health
- Tooth/teeth in question
- Clinical assessment
- Radiological assessment
- Diagnosis
- Reason for referral
- Requested treatment: extraction (open or closed), apical surgery, hemisection,
consultation, unspecified
The data from referral letters will be compared with data in equivalent journal records of
the treatment outcome in every referred case. Each journal record is going to be assessed by
the following criteria:
- Patient chief complaint
- Patient's general health
- Tooth/teeth in question
- Clinical assessment
- Radiological assessment
- Diagnosis
- Treatment indication
- Outcome of referral;
- Treatment: extraction (open or closed), apical surgery, hemisection
- No treatment
The level of difficulty of each referred case is going to be measured by a comparison of the
referral letters to equivalent patient journal and assessment of treatment outcome. The
studied cases will be ranked into one of four categories, wherein categories 1-3 are
considered as complicated.
1. Patients whose general heath increases the risk of postoperative medical complications.
2. Cases wherein exodontia cannot be carried out without elevating a surgical flap.
3. Cases wherein exodontia can affect nearby anatomical structures (such as risk of sinus
perforation and damage to the inferior alveolar nerve).
4. Otherwise healthy patients where exodontia can be carried out by closed extraction
without flap elevation.
Study rational
The recorded data will be analyzed for the level of difficulty, suitability to referral by a
comparison with the judged level of difficulty and for the outcome from treatment.
Comparisons will be made between the judged level of difficulty with the outcome and the
suggested treatment of the referral with the outcome.
Statistical analysis
The sample constitutes of a total inclusion from a cohort limited in time, department and
treatment method. The project is designed as an observational trial without control group.
Thus, a power-analysis is not valued as necessary for this project.
Simple statistical analysis including mean, standard deviation and range will be used. The
limit for statistical significance will be set to p<0.05. A two-sided p-value will be used.
Statistical analysis of the data will be performed by use of SPSS - IBM Inc.
Ethical considerations
The study is to be performed in accordance with the 21 CFR, part 50 and the directives laid
down in the declaration of Helsinki (Appendix 1 of the declaration, as adopted by the 18th
World Medical Assembly, Tokyo, 1975, the 35th WMA, Venice 1983, and the 41st WM A, Hong, Kong
1989, the 48th WMA, Somerset West 1996, the 52nd WMA, Edinburgh 2000 and the clarifications
2002 and 2004).
The project has been submitted to a properly constituted independent Ethics Committee (EC),
in agreement with national rules, for formal approval of the study conduct. The decision of
the EC concerning the conduct of the study will be in writing to the Investigator and a copy
of this decision is archived in the Investigator's Study File.
Patient data protection
The researcher will keep a patient identification list including sufficient information to
link records, i.e. CRFs and hospital records. Swedish and local regulations for the handling
of computerized data will be followed and described in the written patient information and
identification of individual patient data will only be possible for the researcher. A list of
the decoded social security numbers of the patients will be kept at the department of Oral
and Maxillofacial Surgery, only accessible by the principal researcher.
Report and communication of results After completion of the study, the statistical analysis
will be performed by the research group. These data will form the basis for a manuscript
intended for publication in a medical journal within two years of the after the project is
finished.
Significance and implementation
Adequate referrals are important to have the relatively more expensive specialist health-care
units to work as effective as possible. Through a focus of having the best competence
predesignated for the most advanced and difficult treatments, the availability and treatment
cost will be kept at a desirable level. This is true from both a patient, a health-care
provider and a society perspective.
The present study will evaluate the accuracy of the actual referrals in a 12-month time-span.
The outcome will give guidance to decision makers in healthcare strategies. Hence, the
outcome will, in the short coming future affect education of clinicians, specialist unit
geographic establishment and governmental financial support to an improved suitability of
health care resources.
The current project aims to clarify the benefits of directed adequate referrals to
specialized units of Oral and Maxillofacial Surgery. By knowledge of how the level of
existing referrals corresponds to the outcome and how they present, the health care
optimization of specialized availability and referral directions will be supported. After
publication of the results from the present study, the knowledge will be provided to key
decision makers within health care systems.
