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CTRI Number  CTRI/2024/11/077257 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 23/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Viability and motility of bacteria in dental calculus 
Scientific Title of Study   Analysis of bacterial viability and motility in dental calculus: a clinico-microbiological 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. Ajaishalu I 
Designation  Post graduate student 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Sri Rajiv Gandhi College of Dental Sciences and Hospital, Department of Periodontics, Room #12, Chola Nagar, RT Nagar post, Bangalore- 560032

Bangalore
KARNATAKA
560032
India 
Phone  6385325561  
Fax    
Email  ajaishalu59@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aditi Bose 
Designation  Reader 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Department of Periodontics, Room #12, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Chola Nagar, RT Nagar post, Bangalore- 560032

Bangalore
KARNATAKA
560032
India 
Phone  8105851209  
Fax    
Email  dr.aditi2010@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ajaishalu I 
Designation  Post graduate student 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Sri Rajiv Gandhi College of Dental Sciences and Hospital, Department of Periodontics, Room #12, Chola Nagar, RT Nagar post, Bangalore- 560032

Bangalore
KARNATAKA
560032
India 
Phone  6385325561  
Fax    
Email  ajaishalu59@gmail.com  
 
Source of Monetary or Material Support  
Sri Rajiv Gandhi College of Dental Sciences and Hospital, Chola Nagar, RT Nagar post, Bangalore- 560032 
 
Primary Sponsor  
Name  AJAISHALU I 
Address  Sri Rajiv Gandhi College of Dental Sciences and Hospital, Chola Nagar, RT Nagar post, Bangalore- 560032 
Type of Sponsor  Other [Self sponsored] 
 
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 AJAISHALU I  Sri Rajiv Gandhi College of Dental Sciences and Hospital  Department of Periodontics, Room #12, Chola Nagar, RT Nagar post, Bangalore- 560032
Bangalore
KARNATAKA 
6385325561

ajaishalu59@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethical Committee, Sri Rajiv Gandhi College of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects with age group: 25-60 years.
2.Gender: males and females.
3.Subjects having minimum 20 teeth.
4.Subjects with chronic inflammatory periodontal disease with probing depth ≥ 5mm, clinical attachment level ≥ 3mm and substantial calculus deposits on teeth surfaces.
5.Subjects with calculus index score between 0.7 to 3(as per John C. Greene and Jack R. Vermillion, OHI-S index).

 
 
ExclusionCriteria 
Details  1.Patients with any systemic diseases.
2.Patients who have undergone anti-microbial therapy in the past 6 months.
3.Patients who have undergone periodontal therapy in the past 6 months.
4.Pregnant and Lactating women.
5.Patients with salivary gland disease.
6.Patients with xerostomia.
7.Smokers and Tobacco users.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Viability and motility of bacteria  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical parameters oral hygiene index- simplified.  Baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/12/2024 
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  

Periodontitis is a chronic inflammatory process initiated by the plaque biofilm. This is mainly associated with development of destructive periodontal disease, leading to pocket formation, bone loss, and eventually tooth loss. Current understanding of initiation and progression of periodontal disease describes dental plaque to be the primary etiological factor. This biofilm is accompanied by the presence of calculus, which is virtually always covered with unmineralized plaque. Calculus is plaque that mineralizes to form calcified deposits. Although gingivitis can develop in the absence of supragingival calculus, it is not clear to what extent the presence of mineralized deposit enhances gingival inflammation. In the past 40 years, calculus has been deposed by plaque, and the hardened criminal has come to be viewed as a fossilized remnant of minor significance.

Regarding the significance of dental deposits, Schroeder summed up “Initial damage to the gingival margin is presumably due to enzymatic effects caused by the microorganisms of the plaque. This process is enhanced by the formation of supragingival dental calculus, which provides further retention and thus promotes new plaque accumulations”. Plaque induced chronic inflammation eventually results in formation of periodontal pockets in which sub gingival calculus is deposited. The latter is a secondary phenomenon; it is not a cause of pocket formation but a concomitant manifestation.

This subgingival dental calculus in turn favors and promotes the chronicity of the inflammation, and thus, contributes toward making it progressively worse. It has also been thought that calculus is plaque retentive and may impede natural and mechanical oral hygiene activities. It also may act as a reservoir for irritating substances such as endotoxins and bacterial antibodies.

About 20 percent of dental calculus is made of organic matrix, non-mineralized cavities containing micro-organisms, and extra cellular substance resembling that of the covering soft plaque that are found within the body of supragingival calculus. It is known that the environment within a biofilm is able to support viable bacterial communities through molecular diffusion of nutrients through channels and calculus can be permeated by substances such as endotoxins within 24 hours. The possibility therefore exists that a sustainable environment for oral bacteria may be found within the dental calculus and that such organisms may remain viable for some time.

The present study will be undertaken with the aim to investigate the viability of bacteria in dental calculus and to identify the same. The objectives will be to identify the bacterial morphotypes using gram staining and observe the motility of bacteria under dark field microscope.

 
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