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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 
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