Keywords
complete dentures - edentulous mouth - denture quality - satisfaction - adaptation
period of 1–2 weeks
Introduction
Edentulism can affect the health of the patient's oral cavity and the patient's health
in general. Oral conditions affected by edentulism range from resorption of residual
ridges to impaired masticatory function, unhealthy diet, social disability, and poor
oral health quality of life.[1] Edentulism requires treatment in the form of making dentures such as fixed dentures,
implant-supported dentures, removable partial dentures, or complete dentures (CDs),
which can improve masticatory abilities and oral health and have an impact on improving
the patient's quality of life. The use of dentures may help the problems faced by
patients who experience edentulism. However, it is not uncommon for patients to complain
of discomfort about the dentures they are using, which are generally related to the
retention and stabilization of the dentures.[2] To avoid the discomfort patients feel when they have to adapt to their new dentures,
it is necessary to evaluate the quality of a denture first. There is a method discovered
by Basker and colleagues and developed by Corrigan et al and Anastassiadou et al in
a different study called Functional Assessment of Dentures (FAD).[3]
[4]
[5]
[6]
Treatment with conventional CD has been proven successful in providing satisfaction
to the majority of patients. However, some patients remain dissatisfied with their
prostheses, regardless of the quality of the denture itself.[7] Komagamine et al stated that the success of denture treatment is not dependent on
examination by a dentist, but is based on the assessment of the patient who uses the
denture itself.[8] In that study, the level of patient satisfaction with denture treatment was measured
by a Patient's Denture Assessment (PDA)[8] questionnaire ([Table 1]) using a Visual Analogue Scale (VAS), which was later developed by Rezeki et al
in 2017 to become the Indonesian version of the PDA (PDA-Id).[9]
Table 1
Patient's Denture Assessment (PDA)
|
Subscale
|
Questionnaire items
|
|
Function
|
Q1. How much pain do you feel?
|
|
Q2. How easy it is for you to swallow food boluses and water?
|
|
Q3 How well do you enjoy meals?
|
|
Q4. How worn out does your jaw feel?
|
|
Aesthetics and speech
|
Q5. How worried are you about other people watching?
|
|
Q6. How easy is it for you to speak?
|
|
Q7. How worried are you about your mouth?
|
|
Q8. How often do your dentures click when chewing?
|
|
Lower denture
|
Q9. How often does food debris get stuck under your lower denture?
|
|
Q10. How is your lower denture retained on the ridge?
|
|
Q11. How does your lower denture fit?
|
|
Q12. How uncomfortable is your lower denture?
|
|
Expectation
|
Q13. How satisfactory will the new dentures be?
|
|
Q14. How problematic will the new dentures be?
|
|
Q15. How well will the new dentures fit?
|
|
Upper denture
|
Q16. How often does food debris get stuck under your upper denture?
|
|
Q17. How does your upper denture fit?
|
|
Q18. How often does your upper denture fall down?
|
|
Importance
|
Q19. How much do you consider your dentures as part of your body?
|
|
Q20. How important are your dentures to you?
|
|
Q21. How much can you care for your dentures without any difficulty?
|
|
Q22. How at ease do you feel when wearing your dentures?
|
Patient satisfaction with a conventional CD treatment is influenced by several factors,
apart from the quality of the denture itself. Kapur believes that the quality of the
supporting tissue of a denture can also affect the outcome of the treatment performed.[6]
[10] Assessment of the quality of a CD is not only limited to the condition of the CD
but can also be influenced by the condition of the patient's intraoral tissue, such
as the shape of the residual ridge, tissue resistance, and the depth of the vestibule
can affect the adaptation of the denture base, that it can affect the assessment of
the quality of dentures.[10]
The main objective of this study was to obtain a valid and reliable Indonesian version
of the FAD instrument called Indonesian Version FAD (PFGT) so that it can be used
as a valid and reliable measurement tool. This study also aims to find out whether
the functional quality of a CD (measured with PFGT) can affect patient satisfaction
(measured with PDA-Id) in receiving CD treatment and also to analyze contributing
factors to the functional quality of a CD (sociodemographics, length of time the CD
was used, and the quality of the denture-supporting tissue).
Methods
The research consists of two parts, namely, qualitative research and quantitative
research. Qualitative research was conducted in the form of cross-cultural adaptation
methods with translation, backward translation, and expert discussion.[11] Quantitative research was conducted to test the validity and reliability of the
instruments developed with a cross-sectional design and to test the correlation between
the instruments developed against the PDA-Id questionnaire. This research was approved
by the Ethical Committee from the Faculty of Dentistry, Universitas Indonesia, Jakarta,
Indonesia.
Qualitative research begins with cross-cultural adaptation of the FAD instrument ([Table 2]), by forming two teams of translators, namely, the first team to translate the FAD
into Indonesian and the second team to translate the results of the FAD translation
back into English. The first team consisted of two clinicians who spoke fluent Indonesian
and understood English, producing the T-1 and T-2 instruments. After obtaining the
translation results from the two translators, a synthesis was carried out to obtain
the T-12 instrument. Then, a second team, consisting of two clinicians fluent in English
and understanding Indonesian, retranslated the T-12 instrument, which was then compared
with the original FAD instrument to assess whether there was a change in the meaning
of the translation results, and a prefinal instrument was obtained.
Table 2
Functional Assessment of Denture by Anastassiadou
|
No.
|
Parameter
|
Score (1st)/(2nd)
|
|
1
|
Freeway space (FWS)
(Resting vertical dimension [RVD] measured with lower denture in situ)
|
• Adequate = 1
• Wrong = 0
|
|
2i
|
Occlusion
The patient is asked to relax and close gently on back teeth several times from a
slightly open (20 mm) position.
|
• Balanced = 1
• Slide = 0
|
|
2ii
|
Articulation
Lower jaw moved side to side with teeth lightly together. Observe relationship of
denture bases to underlying tissues.
|
• Minimal displacement = 1
• Excessive displacement = 0
|
|
3i
|
Upper retention (resistance to vertical pull)
The mouth is opened 20 mm. Note if denture drops. *With the mouth still open, the
denture is grasped by the thumb and index finger on the premolars and a downward force
applied. (Dry teeth if necessary.) *Repeat if tongue is in a guarded position
|
• Adequate resistance = 1
• No Resistance = 0
|
|
3ii
|
Upper retention/Tongue control, incision test
A cotton wool roll is inserted between the front teeth and the patient is instructed
to close gently onto the roll and bite as if it were a piece of food. The position
of the tongue is noted. Judgment made on third attempt
|
• Upper denture is stabilized by tongue = 1
• Tongue remains in floor of the mouth = 0
|
|
4i
|
Upper stability (lateral displacement)
Denture is grasped by the thumb and index finger in the premolar region and a rotational
force applied
|
Lateral displacement
• No = 1
• Yes = 0
|
|
4ii
|
Upper stability (pronounced rocking)
Light force is applied on the right and left sides in the first molar simultaneously.
Attempt to tip in anteroposterior direction with thumb and index finger placed posteriorly
and anteriorly simultaneously
|
Pronounced movement
• No = 1
• Yes = 0
|
|
5i
|
Lower stability (displacement)
The mouth is opened 20 mm with tongue in relaxed position. Seating of denture checked
with fingers
|
• Lower denture stays in place = 1
• Lower denture is noticeably displaced = 0
|
|
5ii
|
Lower stability (pronounced movement)
The patient is instructed to move the tongue so the tip gently resist at the angels
of the mouth with the mouth opened 20 mm. Check seating of denture with fingers. Judgment
made on third attempt
|
Pronounced movement
• No = 1
• Yes = 0
|
|
5iii
|
Lower stability (anteroposterior movement)
Upper denture removed. The lower denture is held against the ridge by a finger and
thumb on the incisors and attempt made to move it with tongue in relaxed position
|
Anteroposterior movement
• No = 1
• Yes = 0
|
After obtaining the prefinal instrument, a pretest was conducted using the purposive
sampling method on dentists with experience in prosthodontics (prosthodontic residents
or prosthodontists). The number of subjects is 10 dentists[12] who have experience in the field of prosthodontics (prosthodontic resident or prosthodontist),
using the unstructured interview method to obtain the final instrument, which was
called the PFGT. The final instrument was subjected to advanced validation to evaluate
whether the instructions given to the instrument were reasonable, unambiguous, and
straightforward.
Quantitative research was conducted using consecutive sampling method in patients
who have received conventional CD treatment. Inclusion criteria in this study are
patients receiving CD treatment at the Dental Hospital, Faculty of Dentistry, Universitas
Indonesia, aged 45 years and older, who agreed to fill out informed consent, and can
communicate. Exclusion criteria were CDs made by dental technicians, patients with
motoric disability, neurologic conditions, or dementia, and patients who did not want
to participate in the study. Based on the sample size calculation using G-Power, the
required sample was 40 subjects. Sociodemographics data, the time the CD was used,
and the quality of the denture-supporting tissue were obtained from the subjects.
Respondents willing to become research subjects signed an informed consent form; then,
data was collected. Subjects filled out the PDA-Id questionnaire and then filled in
the PFGT instrument by two examiners who were experienced dentists in the field of
prosthodontics and had been calibrated beforehand to be able to fill out questionnaires
and instruments. The PFGT was then tested for test–retest reliability with a subsample
of 10 subjects who would be reexamined in the same way within 7 to 10 days after the
first data collection, and the two examiners collected the data.
Samples are divided into six different groups based on age (between 45 and 59 years
old), sex (male or female), length of time the CD was used (0–6 months, or more than
6 months), quality of denture-bearing area (bad, moderate, or good), patient satisfaction
(satisfied or not), and the quality of the CD (good or bad).
The statistical package SPSS was used to analyze the data in this research. Cohen's
kappa test performed the interexaminer agreement for all data, while the intraexaminer
agreement was performed by test–retest reliability analysis. The instrument was then
tested for internal consistency by performing a Kuder–Richardson (KR) 20 test and
construct validity by performing a Spearman's correlation test compared to PDA-Id.
Result
The validation team decided to use a credible private language translation agency
to translate the original FAD instruments used by the clinicians.
Data was collected by two examiners who were experienced dentists in prosthodontics
from 40 subjects, with 21 male and 19 female patients, 20 first-time denture users
and 20 previous denture users. The interrater reliability (kappa) results obtained
from each item of the PFGT instrument generally had a very good value, while the overall
kappa value was 0.828 (almost perfect agreement).
An instrument stability test was carried out with a subsample of 10 subjects, which
would be reexamined in the same way within 7 to 10 days after the first data collection.
In the test–retest results, a p-value of 0.564 (p > 0.05) was obtained, meaning there was no difference in the total score of the first
and second observations. The intraclass correlation coefficient (ICC) score obtained
from the two examiners was 0.894, based on Oremus et al. If the ICC is above 0.750,
it can be said that the stability of the instrument is excellent.[13]
Then, an internal consistency test was carried out with the Kuder–Richardson 20 test,
and a KR value of 1.08 was obtained, where the instrument's internal consistency was
considered very good. The distribution of the data was not normal; the Spearman's
correlation test was carried out to validate the convergent validation of the PFGT
instrument with the PDA-Id comparator. Based on the results of the Spearman's test,
there is a statistically significant positive correlation between the PFGT instrument
and the PDA-Id questionnaire (p < 0.05); the correlation value (0.32) is considered fair based on Chan.[14]
The area under the receiver operator characteristic curve (AUROC) value of the PFGT
instrument gets a poor interpretation, which means it is relatively weak when correlated
with PDA-Id but can still be declared valid because the AUROC value is > 0.5 (0.659).
A cutoff value with a sensitivity of 70% and a specificity of 60% is still acceptable,
with a value of 8.5. Furthermore, an analysis was performed on factors related to
denture quality, such as age, gender, length of time the CD was used, quality of the
CD support network, and patient satisfaction with CD treatment as measured by PDA-Id.
Based on the chi-square bivariate analysis ([Table 3]), significant factors related to denture quality were the length of time the CD
was used and patient satisfaction with CD treatment as measured by PDI-Id (p < 0.05). CD usage duration of 0 to 6 months is more likely to produce good quality
CD (odds ratio [OR] 0.21, 95% confidence interval [CI] 0.05–1.01, p = 0.042). Patient satisfaction with CD treatment as measured by PDA-Id had a 12.31
times probability of receiving good quality CD (95% CI OR 1.39–109.10; p = 0.008). Furthermore, variables with p-values < 0.25 are entered as multivariate candidates.
Table 3
Bivariate analysis of the relationship between denture quality scores using the PFGT
instrument, and factors such as age, gender, the length of time the CD was used, and
quality of denture supporting tissues
|
Variable
|
Code
|
Category
|
Bad (score < 8.5)
N = 17
|
Good (score ≥ 8.5)
N = 23
|
Total
|
p-Value
|
OR
|
95% CI OR
|
|
n
|
%
|
n
|
%
|
|
Age
|
0
|
45–59 years old
|
6
|
40.0
|
9
|
60.0
|
15
|
0.804
|
1.00
|
|
|
|
1
|
> 60 years old
|
11
|
44.0
|
14
|
56.0
|
25
|
|
0.85
|
0.23
|
3.11
|
|
Gender
|
0
|
Male
|
7
|
33.3
|
14
|
66.7
|
21
|
0.218
|
1.00
|
|
|
|
1
|
Female
|
10
|
52.6
|
9
|
47.4
|
19
|
|
0.45
|
0.13
|
1.62
|
|
The length of time the CD was used
|
0
|
0–6 mo
|
10
|
33.3
|
20
|
66.7
|
30
|
0.042[a]
|
1.00
|
|
|
|
1
|
> 6 mo
|
7
|
70.0
|
3
|
30.0
|
10
|
|
0.21
|
0.05
|
1.01
|
|
Quality of denture-supporting tissue
|
0
|
Bad (score < 14)
|
8
|
53.3
|
7
|
46.7
|
15
|
0.515
|
1.00
|
|
|
|
1
|
Moderate (score 14–17)
|
8
|
34.8
|
15
|
65.2
|
23
|
|
2.14
|
.58
|
8.09
|
|
2
|
Good (score > 17)
|
1
|
50.0
|
1
|
50.0
|
2
|
|
1.14
|
.06
|
21.87
|
|
Patient satisfaction with CD treatment (PDA-Id)
|
0
|
Dissatisfied (< 2040)
|
16
|
55.2
|
13
|
44.8
|
29
|
0.008[a]
|
1.00
|
|
|
|
1
|
Satisfied (≥ 2040)
|
1
|
9.1
|
10
|
90.9
|
11
|
|
12.31
|
1.39
|
109.10
|
Abbreviations: CD, complete denture; CI, confidence interval; OR, odds ratio; PDA-Id,
Indonesian version of Patient's Denture Assessment; PFGT, Indonesian Version Functional
Assessment of Dentures.
a
p < 0.05.
The results of multivariate analysis with logistic regression ([Table 4]) showed that what affected the quality of the denture was the length of time CD
was used and the patient's satisfaction with CD treatment. The final result is a model
that only consists of two variables: the length of time the CD was used and patients
who are satisfied with CD treatment. The magnitude of the influence of these variables
is that the duration of using a CD for “0 to 6 months” has a greater probability of
getting a CD with good quality (OR 0.215, 95% CI 0.041–1.127, p 0.069). Patient satisfaction with CD treatment who was “satisfied” had a risk of
4.487 times (95% CI OR 1.078–18.668; p = 0.039) to get good-quality dentures. From the results of the multivariate analysis,
it can be said that the most significant influence on denture quality measured using
the PFGT instrument is “patient satisfaction,” as measured using the PDA-Id with an
OR of 4.487.
Table 4
Multivariate analysis (final model) of the relationship between denture quality using
the PFGT instrument and sociodemographic factors, the length of time the CD was used,
and the quality of denture supporting tissue
|
Variable
|
Category
|
Coefficient
|
SE
|
p-Value
|
OR
|
95% CI OR
|
|
Lower
|
Upper
|
|
The length of time the CD was used
|
> 6 mo vs. 0–6 mo
|
–1.537
|
0.845
|
0.069[b]
|
0.215
|
0.041
|
1.127
|
|
Patient satisfaction with CD treatment (PDA-Id)
|
Satisfied (≥ 2040)
vs. Dissatisfied (< 2040)
|
1.501
|
0.727
|
0.039[a]
|
4.487
|
1.078
|
18.668
|
|
Constant
|
|
–0.14
|
0.507
|
0.978
|
0.986
|
|
|
Abbreviations: CD, complete denture; CI, confidence interval; OR, odds ratio; PDA-Id,
Indonesian version of Patient's Denture Assessment; PFGT, Indonesian Version Functional
Assessment of Dentures; SE, standard error.
a
p < 0.05.
b
p < 0.1.
Discussion
As Beaton et al explained in his guide to cross-cultural adaptation, an instrument
used in another country with a different language should require cross-cultural adaptation
to ensure consistent content validity between the source and target instrument being
developed.[11] Several questions in this instrument cannot be translated directly from English
to Indonesian due to cultural differences, such as the use of 3 to 7 mm freeway space
(FWS) used by previous researchers,[3]
[4]
[6]
[7] where the common FWS used in the researcher region is 2 to 4 mm.[15]
The Spearman's correlation test was carried out on the PFGT instrument on the PDA-Id
questionnaire instrument with a p-value of 0.044 (p < 0.05), indicating a correlation between the PFGT instrument and the PDA-Id questionnaire.
However, the Spearman's correlation coefficient obtained was 0.320 (0.3–0.4 = fair),
which indicates a positive correlation that is not strong from this assessment. From
the results of the correlation test, based on the interpretation of Chan,[14] it can be concluded that there is a weak correlation between patient satisfaction
with denture treatment and denture quality. This result is supported by several other
studies stating that many factors influence patient satisfaction with dentures, such
as patient expectations and psychological factors.[3]
[16]
[17]
[18] According to Carlsson, patients with too high expectations are at risk of experiencing
dissatisfaction with the CD treatment they receive, so the dentist's job here is to
adjust the patient's expectations of CD treatment and explain all the limitations
of CD compared to natural teeth.[17] Guckes, in his research, showed that patient satisfaction with the CD received correlated
with the patient's opinion of the denture, where this can be easily handled if a counseling
session is held with the dentist to improve the patient's opinion of the CD treatment,
as well as lowering patient expectations.[19] Another factor influencing patient satisfaction with dentures is psychological factors;
16% of patients still complain about their CD even though the quality of the CD is
considered good enough.[18] This is closely related to neuroticism, a condition in which the patient is always
disposed to have negative thoughts about everything that happens in their life.[20]
Although it has been widely reported that patients may be dissatisfied with the CD
care they receive, even though the quality of the CD is considered good, the opposite
can also happen, where the quality of the CD is considered lower than the standards.
However, patients are still satisfied with the CD they received. This was revealed
by Carlsson, that “a good relationship between doctor and patient is more important
than a suitable denture manufacturing procedure, in getting patient satisfaction.”[16] This shows that good communication between doctors and patients is one of the primary
keys in achieving patient satisfaction with the CD treatment received.
Some literature states that many factors can influence patient satisfaction with denture
care. However, in this study, we wanted to know what factors could have a relationship
with the quality of a denture. A chi-square bivariate test was performed with factors
such as age, gender, the length of time the CD was used, quality of denture-supporting
tissue, and patient satisfaction with dentures. The test results found that the length
of time the CD was used was related to the denture's functional quality. This is in
line with Ribeiro et al's research, where the quality of a denture will continue to
decline over time.[21] In Leles et al's study, it was found that denture quality improved after 3 months
of use but decreased after 6 months. This is because the patient underwent a process
of adaptation to dentures during the first 3 months, but the supporting tissue of
the dentures underwent changes after using CD for 6 months.[6] Further research is needed regarding the relationship between the quality of dentures
and the age of dentures due to the limitations of this study, which are only cross-sectional,
so there is no assessment of intraindividual changes over time, whether there is an
increase or decrease in quality according to previous research.
As previously discussed, patient satisfaction with dentures has a relationship with
denture quality, which indicates a relationship between patient satisfaction with
dentures and denture quality, although the Spearman's correlation test proved to have
a weak relationship. From the results of multivariate analysis, it was found that
patient satisfaction with CD treatment had an OR of 4.487, which means that patients
who are satisfied with their CD are 4.487 times more likely to get a good-quality
CD. This is in line with the results of the Celebić et al study in 2003, which stated
that denture quality has a strong correlation with patient satisfaction, besides other
factors such as education level, economic status, and quality of life.[22]
In future studies, it is necessary to conduct a prospective study to assess the correlation
between denture quality and wear over time by comparing new and old dentures in the
same individual. In other studies by Cerutti-Kopplin et al, it is also necessary to
relate to other factors like retention, comfort, esthetic, phonetics, and different
adaptation periods.[7]
[23] In addition, in future studies, illustrations or videos should be provided to give
an overview of the operators' examinations.
Conclusion
Quantitative research has succeeded in testing the validity and reliability of the
instruments that have been developed, as well as proving a positive correlation between
CD quality and patient satisfaction with CD treatment. In addition, this study also
showed a relationship between the quality of the CD and the length of time the CD
was used. However, this study found that there was no relationship between sociodemographics
and the supporting tissue quality, on the quality of CD.
This instrument will later become a measuring tool widely used to obtain further research
data and can help to be considered for decision-making whether a patient needs a new
CD or just some repairs to the old one.
