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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  
Status 
Not Applicable 
 
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. Peri‐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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