| CTRI Number |
CTRI/2023/12/060946 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Interview and Questionnaire) |
| Study Design |
Other |
|
Public Title of Study
|
Awareness and pitfalls among public regarding the use of interdental aids for implant maintenance |
|
Scientific Title of Study
|
Evaluation of the knowledge, attitude, and practice of using interdental aids and factors
affecting its non-adherence among the people with dental implants: a mixed-methods study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malvika Shyamkumar R |
| Designation |
Post graduate student |
| Affiliation |
Manipal college of dental Sciences Manipal |
| Address |
Room No.3
Department of Periodontology
Manipal college of dental Sciences Manipal
Udupi
Udupi KARNATAKA 576104 India |
| Phone |
7406019780 |
| Fax |
|
| Email |
malvikashyam1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aditi Chopra |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of dental Sciences Manipal |
| Address |
Room No.3
Department of Periodontology
Manipal college of dental Sciences Manipal
Udupi
Udupi KARNATAKA 576104 India |
| Phone |
9739863908 |
| Fax |
|
| Email |
aditi.chopra@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Malvika Shyamkumar R |
| Designation |
Post graduate student |
| Affiliation |
Manipal college of dental Sciences Manipal |
| Address |
Room No.3
Department of Periodontology
Manipal college of dental Sciences Manipal
Udupi
Udupi KARNATAKA 576104 India |
| Phone |
7406019780 |
| Fax |
|
| Email |
malvikashyam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences Manipal Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Malvika Shyamkumar R |
| Address |
Room No 3
Department of Periodontology
Manipal College of Dental Sciences Manipal
Udupi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aditi Chopra |
Room No.3
Department of Periodontology
Manipal College of Dental Sciences Manipal
Udupi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Malvika Shyamkumar R |
Manipal Dental College and Hospital |
Room No 3
Department of Periodontology
Manipal College of Dental Sciences Manipal
Udupi Udupi KARNATAKA |
07406019780
malvikashyam1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with dental implants with or without Peri-implant diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants above 18 years of age
Participants who are willing to take part in the survey with written consent
Participants who have dental implant prosthesis in their mouth for at least 6 months from the date of data collection
|
|
| ExclusionCriteria |
| Details |
Participants below 18 years of age
Participants who haven’t undergone dental implant placement in their oral cavity Mentally and physically disabled patients
Participants who have had dental implant prosthesis in their oral cavity for less than 6 months
Dentists or Health care professionals including dental hygienists.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge attitude and practice methods used for maintaining Oral Hygiene |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of patient education/ instructions & problems faced by the population in using interdental aids |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="550" Sample Size from India="550"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental implants have become
a viable and promising treatment alternative for replacing missing teeth in
patients with good general oral health and adequate bone dimension.
Around 909,643
of the Indian population receive implant treatment per year. The most important
advantage of dental implant is that it helps to restore the occlusion and
replace missing teeth without compromising the adjacent teeth as an abutment.
It enhances the quality of life and has a good long-term prognosis compared to
many prosthetic treatments such as post and core and multiple crowns and
bridges. With rapid awareness about dental implants, many patients are seeking
implant placement in both rural and urban areas. However, one should note
that even though the placement of dental implants is rapidly increasing, the
level of awareness regarding how to maintain the implants after placement is
less among both dentists and patients. Many patients suffer from implant failure
and post-placement complications, with periimplantitis being the most common. According to the
literature, approximately 79% of individuals rehabilitated with implants are
affected by peri-implant mucositis, and 50% of implants are affected with
peri-implantitis. At the present times, peri-implantitis has become a
global burden that occurs with a frequency from 1% to 47% at implant level. One of the main aetiologies
for the rapid rise in periimplantitis is the lack of maintenance and poor oral
hygiene among implant patients. Poor oral hygiene and the
formation of plaque and calculus around the peri-implant mucosa and implant
surface will lead to peri-implantitis. The earliest sign of
inflammation around the peri-implant mucosa begins with the presence of
bleeding. This is known as peri-implant mucositis. Peri-implant
mucositis when left untreated leads to peri-implantitis. Periâ€implantitis is a
pathological condition occurring in tissues around dental implants,
characterized by inflammation in the peri-implant mucosa and progressive loss
of supporting bone. The primary and most effective
method for plaque control around dental implants is to maintain good oral
hygiene at home and have regular dental checkups with professional dental
cleaning. Apart from regular scaling, various mechanical and
chemical plaque control agents are being prescribed to patients to maintain
good oral hygiene around implants. A toothbrush is the most common tool used by
patients for plaque control at home. Additionally, floss, interdental brushes,
and oral irrigators (Waterpik) are being advised by dentists for plaque
control. Since the removal of plaque from interproximal or interdental surfaces
of the teeth, especially with dental implants where the presence of gingival
embrasure is inevitable due to lack of inter-implant papilla, the use of
interdental aid is deemed necessary. The use of only a toothbrush may not be
effective to maintain optimal plaque control in individuals with gingival
embrasure, pontics, and implant prosthesis. The bristles of
toothbrushes may not be able to effectively remove plaque under the surfaces of
implant crowns and bridges, leading to an increased risk of plaque
buildup and inflammation around implants. Interdental aids have proven to be effective in
decreasing plaque accumulation and preventing periodontal disease by 80% (ADA)
and those with peri-implantitis. Although
various interdental aids are available in the market, the use of interdental
aids is limited among the general population. It is also noted that floss and interdental
brushes are prescribed by dentists, but many people do not use them regularly.
There is a general lack of awareness among the people regarding how to use it, adherence to usage, and recognition of its importance. Therefore,
with this objective in mind, this mixed-method study aims to assess the
knowledge and attitudes of patients with dental implants toward interdental
cleaning aids, and the factors that are responsible for their non-usage. The
study also aims to assess any pitfalls and shortcomings that exist in oral
hygiene instruction given by dentists, which leads to non-adherence.
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