| CTRI Number |
CTRI/2024/11/077256 [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
|
Salivary melatonin levels and periodontal disease |
|
Scientific Title of Study
|
Effect of full mouth disinfection on salivary melatonin levels and tannerella forsythia in chronic periodontitis patients: a clinical, biochemical and 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 Cheppalli Naga Pranavi |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Rajiv Gandi College of Dental Sciences and Hospital |
| Address |
Department of periodontology, Room no 12, Sri Rajiv Gandi College of Dental Sciences and Hospital,
Cholanagar, R.T.Nagar post, Bengaluru, 560032
Bangalore KARNATAKA 560032 India |
| Phone |
8464049431 |
| Fax |
|
| Email |
c.pranavireddy1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Umesh Yadalam |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Rajiv Gandi College of Dental Sciences and Hospital |
| Address |
Department of Periodontology,
Room no 12, Sri Rajiv Gandi College of Dental Sciences and Hospital,
Cholanagar, R.T.Nagar post, Bengaluru, 560032
Bangalore KARNATAKA 560032 India |
| Phone |
9844269511 |
| Fax |
|
| Email |
umeshyadalam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Cheppalli Naga Pranavi |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Rajiv Gandi College of Dental Sciences and Hospital |
| Address |
Department of Periodontology, Room no 12, Sri Rajiv Gandi College of Dental Sciences and Hospital,
Cholanagar, R.T.Nagar post, Bengaluru, 560032
Bangalore KARNATAKA 560032 India |
| Phone |
8464049431 |
| Fax |
|
| Email |
c.pranavireddy1@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 |
Cheppalli Naga Pranavi |
| Address |
Sri Rajiv Gandi College of Dental Sciences and Hospital, Cholanagar, R.T.Nagar post, Bengaluru, 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 Cheppalli Naga Pranavi |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Department of Periodontics Room #12, Chola Nagar, R.T Nagar Post, Bangalore, 560032 Bangalore KARNATAKA Bangalore KARNATAKA |
8464049431
c.pranavireddy1@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 |
full mouth disinfection |
Patients will receive full mouth disinfection after base line saliva sampling |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
For group A (healthy periodontium): Subjects with age group: 25-50 years both males and females. Individuals having 20 teeth or more. Systemically healthy participants. Intact periodontium with BOP less than 10% and PD less than or equal to 3mm without clinical attachment loss or radiographic sign of alveolar bone destruction. For group B (chronic periodontitis): Chronic periodontitis with CAL greater than or equal to 2 mm, PD greater than or equal to 5 mm and radiographic bone loss extending to the mid-third of the root or beyond.
|
|
| ExclusionCriteria |
| Details |
Patients with any systemic diseases. Patients taking medication affecting periodontal health. Patients who have undergone periodontal therapy in the past 6 months. Pregnant and lactating women. Participants with xerostomia. Smokers and Tobacco users.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Salivary melatonin levels, tannerella forsythia |
Baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical parameters plaque index, gingival index, probing pocket depth, clinical attachment level and bleeding on probing |
Baseline and 3 months |
|
|
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)
|
15/12/2024 |
| 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 described as an inflammatory process, initiated by plaque biofilm that leads to loss of periodontal attachment to the root surface and adjacent alveolar bone which ultimately results in bone loss. The inflammatory and immune responses to the bacteria that colonize the periodontal and associated tissue creates a bidirectional series of host- microbial interactions. While the primary etiologic agent is predominantly gram-negative bacteria within the sub gingival biofilm, the majority of periodontal tissue destruction is caused by an inappropriate host response to those microorganisms and their products more specifically a loss of homeostatic balance between proteolytic enzymes and their inhibitors and reactive oxygen species and the antioxidant defence systems resulting in generation of free radicals leading to decrease in the anti- oxidant defence. One such microorganisms which is recognized as microbial pathogen implicated in the development of periodontal disease by inducing loss of homeostatic balance and resulting in generation of free radicals is Tannerella forsythia. It is a gram-negative anaerobic rod with tapered ends, described as fusiform bacteroides in one of the culture report of progressing advanced periodontitis. The search is on to investigate the pathological potential of various bacteria responsible for periodontal diseases. Past difficulties with identification and culture of Tannerella forsythia have probably been the main reasons why this organism has not been as extensively studied as other putative periodontal pathogens.
Melatonin is an indoleamine hormone produced by the pineal gland that governs the human body’s circadian rhythm and biological clock, plays an important role in the control of periodontal disease due to its significant anti-inflammatory and anti-oxidant property by directly neutralizing the highly destructive reduced oxygen species generated by oxygen derived free radicals. And it can also block reduced oxygen species produced by the superoxide dismutase therefore playing an important role in regulatory bone resorption process. It has ability to bind metals suppresses bacteria development in invitro which is linked to periodontitis. Melatonin levels can fluctuate in periodontitis due to oxidative stress and bacterial invasion caused by loss of homeostatic balance between proteolytic enzymes and their inhibitors. Full mouth disinfection is one of the nonsurgical treatment options for periodontitis, in which the bacterial biofilm is removed, reducing the bacterial burden and hence the rate of formation of free radicals. Saliva as a mirror of oral and systemic health is a valuable source of clinically relevant information because it contains biomarkers and also bacteria specific for the unique physiologic aspects of periodontal disease. Hence interest in saliva as a diagnostic and a medium for prognosticate periodontal treatment outcomes in escalating due to its advantages over other diagnostic biofluids as it is readily available which makes the collection process fairly straight forward with no potential for cross contamination.
Although the potential therapeutic effect of melatonin in periodontitis has been well documented in various in vitro, animal studies and clinical trials, the relation ship between the periodontal status and the influence of periodontal treatment on salivary melatonin and levels of Tannerella forsythia in saliva is still conclusive, the present study was aimed to evaluate the effect of full mouth disinfection on salivary melatonin levels of Tannerella forsythia in saliva in patients with chronic periodontitis and also to explore the possible correlations between clinical parameters, salivary melatonin levels and levels of Tannerella forsythia in saliva. |