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CTRI Number  CTRI/2024/09/074420 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating Three Approaches to Treat Bad Breath and Gum Issues: A Comparative Study 
Scientific Title of Study   Clinical Efficacy of Three Different Full Mouth Disinfection Protocols for the treatment of Halitosis and Periodontitis- A Comparative Randomized Controlled Trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sameer Anil Zope 
Designation  Associate Professor 
Affiliation  School of Dental Sciences, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad 
Address  Department of Periodontology, School of Dental Sciences, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad

Satara
MAHARASHTRA
415539
India 
Phone  9890669053  
Fax    
Email  aoldentist@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sameer Anil Zope 
Designation  Associate Professor 
Affiliation  School of Dental Sciences, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad 
Address  Department of Periodontology, School of Dental Sciences, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad


MAHARASHTRA
415539
India 
Phone  9890669053  
Fax    
Email  aoldentist@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sameer Anil Zope 
Designation  Associate Professor 
Affiliation  School of Dental Sciences, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad 
Address  Department of Periodontology, School of Dental Sciences, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad


MAHARASHTRA
415539
India 
Phone  9890669053  
Fax    
Email  aoldentist@gmail.com  
 
Source of Monetary or Material Support  
Krishna Vishwa Vidyapeeth (Deemed to be University), Pune-Bangalore Highway, Malkapur, Karad, Maharashtra, India. Pincode-415539 
 
Primary Sponsor  
Name  Krishna Vishwa Vidyapeeth 
Address  Krishna Vishwa Vidyapeeth (Deemed to be University), Karad - 415539, Dist- Satara, Maharashtra, India 
Type of Sponsor  Private hospital/clinic 
 
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 Sameer Zope  School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad  Room no.4, Department of Periodontology, School of Dental Sciences, Krishna Vishwa Vidyapeeth (Deemed to be University), Pune-Bangalore Highway, Malkapur, Karad, Maharashtra, India. Pincode-415539
Satara
MAHARASHTRA 		 9890669053

aoldentist@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Krishna Vishwa Vidypaeeth (Deemed to be University)e  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 
Comparator Agent  Conventional Full Mouth Disinfection Protocol  1. Procedure Overview: - FMD aims to perform scaling and root planning within one or two visits within a 24-hour range to prevent cross-contamination between treated and untreated quadrants. - Manual/ultrasonic instruments are used for scaling and root planning, with approximately one hour allocated for each quadrant. 2. Disinfection Protocol Steps: - Brushing the back of the tongue for 60 seconds with a 1% chlorhexidine gel. - Two rinses with a 0.2% chlorhexidine solution for one minute, ensuring gargling during the last 10 seconds to reach the tonsils. - Subgingival irrigation of all periodontal pockets for 10 minutes in three intervals with a 1% chlorhexidine gel. - Instruct patients to use 0.2% chlorhexidine mouthwash twice daily for two weeks. - Provide oral hygiene instructions including interdental plaque control with interdental brushes or toothpicks and brushing the back of the tongue twice a day. Treatment Procedure will be completed withing 24 hours and patients will followed up till 90 days to check improvements in various parameters. 
Intervention  Herbal Full Mouth Disinfection Protocol  1. Procedure Overview: - Similar to FMD, the aim is to perform scaling and root planning within one or two visits within a 24-hour range to prevent cross-contamination between treated and untreated quadrants. - Manual/ultrasonic instruments are used for scaling and root planning, with approximately one hour allocated for each quadrant. 2. Disinfection Protocol Steps: - Brushing the back of the tongue for 60 seconds with a curcumin gel. - Two rinses with Curcumin mouthwash solution for one minute, ensuring gargling during the last 10 seconds to reach the tonsils. - Subgingival irrigation of all periodontal pockets for 10 minutes in three intervals with curcumin gel. - Instruct patients to use Curcumin mouthwash twice daily for two weeks. - Provide oral hygiene instructions including interdental plaque control with interdental brushes or toothpicks and brushing the back of the tongue twice a day. Treatment Procedure will be completed withing 24 hours and patients will followed up till 90 days to check improvements in various parameters.  
Intervention  Photodynamic Full Mouth Disinfection  1. Procedure Overview: - Similar to FMD and Herbal Full Mouth Disinfection, the aim is to perform scaling and root planning within one or two visits within a 24-hour range to prevent cross-contamination between treated and untreated quadrants. - Manual/ultrasonic instruments are used for scaling and root planning, with approximately one hour allocated for each quadrant. 2. Photodynamic Disinfection Protocol Steps: - Brushing the back of the tongue for 60 seconds with chitosan enriched Indocynine Green dye solution followed by diode laser irradiation of the tongue. (Photosensitizer Indocynine Green dye has complete absorption spectrum ranging from of 800- to 810-nm wavelengths) - Two rinses with Indocynine Green dye solution for one minute, ensuring gargling during the last 10 seconds to reach the tonsils, followed by diode laser irradiation of the tonsils. - Subgingival irrigation of all periodontal pockets for 10 minutes in three intervals with Indocynine Green dye followed by diode laser irradiation. - Provide oral hygiene instructions including interdental plaque control with interdental brushes or toothpicks and brushing the back of the tongue twice a day. Treatment Procedure will be completed withing 24 hours and patients will followed up till 90 days to check improvements in various parameters. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects aged between 18-65 years and diagnosed with Halitosis and Stage II/III/IV of periodontitis. Halitosis will be confirmed by organoleptic scoring method and by using portable volatile sulfur compound monitor Tanita HC-312F Fitscan Portable Breath Checker. The red code indicates high levels of VSCs suggesting malodor or bad breath.
Periodontitis will be classified using AAP 2017 Classification of Periodontal & Peri-implant diseases.
2. Subjects with willingness to participate and provide informed consent.
 
 
ExclusionCriteria 
Details  1. Patients with systemic conditions, medications affecting periodontal health and production of volatile sulfur compounds.
2. Subjects with ENT infections, upper and lower respiratory tract infections, GERD, renal diseases, liver disorders
3. Subjects with adverse oral habits like smoking, tobacco or gutkha chewing
4. Individuals with contraindications to specific protocols (e.g., allergies to chemical antiseptics, photosensitizers, herbal components).
5. Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Periodontal parameters like Gingival index (GI), Plaque Index (PI), Pocket probing depth (PPD), clinical attachment level (CAL) and severity of halitosis using Organoleptic Scoring, Tongue Coating index (TCI) will also be assessed pre and postoperatively at 45 days and 90 days respectively.   Improvements in periodontal health and reduction in halitosis following treatment offered in three treatment groups as evidenced by improvements in outcome variables assessed pre and post operatively (at Baseline, 45 days and 90 days post treatment respectively).  
 
Secondary Outcome  
Outcome  TimePoints 
Economic Outcomes: Cost-effectiveness of the treatment, including direct & indirect costs.

Functional Outcomes: Improvements in chewing efficiency, speech, & other functional aspects of oral health.

Aesthetic Outcomes: Patient satisfaction with the aesthetic results of the treatment. 		 improvements in secondary outcome variables assessed pre & post operatively. (at Baseline, 45 days & 90 days post treatment respectively). 
 
Target Sample Size   Total Sample Size="189"
Sample Size from India="189" 
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   Phase 2 
Date of First Enrollment (India)   01/01/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Background: Halitosis (bad breath) and Periodontitis are prevalent oral health conditions with multifactorial causes, significantly impacting individuals’ quality of life and oral health. Traditional treatment methods involve quadrant wise scaling and root planning, conventional full mouth disinfection protocol, but advancements in dental research explore alternative protocols like Herbal Full Mouth Disinfection and Photodynamic Full Mouth Disinfection to enhance outcomes and minimize side effects.

Primary Purpose:  

The primary purpose of this study is to evaluate and compare the effectiveness of three full mouth disinfection protocols—Conventional, Herbal, and Photodynamic—in treating Halitosis and Periodontitis. By investigating these approaches, the study aims to identify potentially more effective treatment options that could enhance patient outcomes and minimize side effects associated with traditional methods.

Study Hypothesis:  

The hypothesis posits that the Herbal and Photodynamic Full Mouth Disinfection protocols will demonstrate superior efficacy in reducing periodontal pocket depth, improving gingival health, and sustaining malodor reduction compared to the Conventional method, thereby offering more effective alternatives for managing Halitosis and Periodontitis.

 
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