CTRI Number |
CTRI/2016/06/007000 [Registered on: 06/06/2016] Trial Registered Retrospectively |
Last Modified On: |
20/04/2016 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
A questionnaire study to evaluate the awareness, knowledge and attitude of patients towards dental implants |
Scientific Title of Study
|
Awareness, Knowledge and Attitude Of Patients Towards Dental Implants : A Cross - Sectional Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrTenneti Shanti |
Designation |
Post Graduate student |
Affiliation |
Yenepoya Dental College |
Address |
Dr.Tenneti Shanti
Post Graduate
Dept of Periodontics
Yenepoya Dental College
Deralakatte
Mangalore
Dakshina Kannada KARNATAKA 575018 India |
Phone |
7406050967 |
Fax |
|
Email |
shanti.tenneti@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajesh H |
Designation |
Professor |
Affiliation |
|
Address |
Dr.Rajesh H
Department of Periodontics,
Faculty of Dentistry,
Melaka-Manipal Medical College,
Jalan Batu Hampar,
Bulkit Baru, Melaka, Malaysia
75150 Other |
Phone |
6018-3773079 |
Fax |
|
Email |
drsharaj@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrTenneti Shanti |
Designation |
Post Graduate Student |
Affiliation |
Yenepoya Dental College |
Address |
Dr.Tenneti Shanti
Post Graduate
Dept of Periodontics
Yenepoya Dental College
Deralakatte
Mangalore
Dr.Tenneti Shanti
Room no 109
Gardyenia Hostel C- Block
Yenepoya University
Deralakatte
Mangalore-575018
Karnataka Dakshina Kannada KARNATAKA 575018 India |
Phone |
7406050967 |
Fax |
|
Email |
shanti.tenneti@gmail.com |
|
Source of Monetary or Material Support
|
Yenepoya Dental College, Mangalore |
|
Primary Sponsor
|
Name |
DrTShanti |
Address |
Dr.T.Shanti
Post graduate,
Dept of Periodontology,
Yenepoya Dental College,
Deralakatte, Mangalore-575018 |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Tenneti Shanti |
Yenepoya Dental College |
Room no 7,
Department of Periodontology Dakshina Kannada KARNATAKA |
7406050967 07406050967 shanti.tenneti@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Yenepoya University Ethics Committe |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
This will be closed ended objective type questionnaire study prepared to assess subjects awareness, knowledge and attitude regarding implant therapy. |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Female |
Details |
1. Age group 18 to 60 years.
2. Patients with one or more missing teeth other than 3rd molars.
3. Systemically healthy patients.
4. Subjects with a lie score < 5
|
|
ExclusionCriteria |
Details |
1. Below 18yrs of age.
2. Pregnant women or lactating women.
3. Uncontrolled diabetes or hypertension
4. Pre existing nerve injury or paresthesia
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. To determine the awareness, knowledge and attitude of subjects towards dental implants as a treatment modality among general population.
|
1 year
|
|
Secondary Outcome
|
Outcome |
TimePoints |
personality assessment,
expectations regarding implant treatment and change in awareness, knowledge and attitude after 1 year |
1 year |
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
02/12/2013 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="7" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This was a structured questionnaire based study. 3
questionnaires were formulated in printed and online formats. The questionnaire
A evaluated the awareness, knowledge and attitude of
subjects towards dental implants as a treatment modality. The questionnaire B assessed the influence of
personality traits on decision making ability. The questionnaire C assessed patient’s
expectations regarding pain, anxiety, function and esthetics before and after
placing dental implants. In
the pilot study, we found 6 questions from questionnaire A to be non-reliable.
We deleted 2 questions and rephrased 4 questions. The final questionnaire A
consisted of 12 questions. 27 questions from questionnaire B which assessed the
psychoticism trait were excluded as they were found to be beyond the scope of
this study and the respondents opined that questionnaire B was time consuming.
We selected a Revised Eysenck Questionnaire with 57 questions for the study.
The
study was conducted in 4 stages.
In the first stage, objective assessment of awareness,
knowledge and attitude was done. We set 50% knowledge level as the benchmark
based on previous studies. We found a significant severe knowledge deficit in
all the 3 parameters .The knowledge deficits were widely
distributed across age, gender, education and occupation groups with no significant
correlation.
In
the second stage, we conducted an interactive educational sessions using
audio-visual aids. A limited number
of subjects participated in the educational sessions to improve the knowledge
deficit. There was a significant improvement in the knowledge post educational
sessions. We made an attempt to assess the influence of
personality traits on decision making ability of subjects who agreed and did not agree to participate in the educational sessions. We used Eysenck
personality test for this assessment. We found that subjects in both the groups
showed a tendency towards extrovertism and neuroticism. A single personality trait
did not influence the participation of subjects in educational sessions. However
detailed analysis should be done in future studies.
In
the third stage, we followed up the patients who agreed to undergo implant
treatment in our institution. We tried to assess if personality traits
significantly differed among the subjects who opted for implant treatment and who
did not using Eysenck Personality Inventory Questionnaire. Subjects in both the
groups showed a tendency towards extrovertism and neuroticism. There was no
significant influence of personality traits on decision making. However, the
sample size was relatively small in both the groups. Hence
there is a need to conduct structured longitudinal studies using a larger
sample size to validate the results.
We
tried to assess if patients’ attitude towards dental implants changed post
treatment. This was measured in terms of pain, anxiety, functional and esthetic
benefits using VAS scale. There was a
significant improvement in patient’s perception of dental implant as a
treatment modality. This suggests that professionally imparted knowledge can
bring about a change in the attitude towards a treatment modality. However
sample size was limited and results should be interpreted with caution.
In
the 4th stage, we re-assessed
awareness, knowledge and attitude of patients towards dental implants in the
treated group after 1 year. We found a significant improvement in the level of
information, subjective and objective need for information. This suggests that
there was retention of imparted knowledge even at the end of 1 year. Hence we
can assume that knowledge reinforcement had a positive impact on this
sub-population.
A single session of educational intervention using
interactive audio-visual aid had a significant improvement in knowledge. However
it has been shown that frequent reinforcement of knowledge can bring about
tangible benefits for longer term. Hence we may opine that frequent innovative upgradation
of educational material and establishing a good rapport with the patients can
bring about a significant change in awareness, knowledge and attitude of
patients towards dental implants.
Limitation
of questionnaire based studies is that evaluation of results is based on self-reported
data. The misinterpretation of questions and memory errors can cause
measurement errors. In our study educational intervention was limited to a
small population. Studies have shown that educational efforts should not
limited to smaller populations and target the general public. However a study
with a larger sample size and respondents with varied cultural and ethnic backgrounds
is needed to validate the conclusion. |