| 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
|
|
|
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
|
|
|
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 accumulationsâ€. 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. |