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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  
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 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  
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  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.


 
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