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CTRI Number  CTRI/2024/01/062121 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized Factorial Trial 
Public Title of Study   BioAerosol Reduction - Need of an Hour. 
Scientific Title of Study   Evaluation and comparison of chlorhexidine and neem mouthwash as a preprocedural rinse on bioaerosol production in patients undergoing implant therapy. A clinic- 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  Pranjal Gaba  
Designation  Intern 
Affiliation  SGT Dental College 
Address  Room Number - 011, Department of Periodontology, Faculty of dental sciences, B- Block Sgt dental college, Gurgaon - Badli Road chandu Budhera, Gurugram - Haryana 122505.
Room Number - 011, Department of Periodontology, Faculty of dental sciences, B- Block Sgt dental college, Gurgaon - Badli Road chandu Budhera, Gurugram - Haryana 122505.
Gurgaon
HARYANA
122505
India 
Phone  8607004786  
Fax    
Email  pranjalgaba11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Shalini Kapoor 
Designation  Professor 
Affiliation  SGT Dental College 
Address  Room Number - 011, Department of Periodontology, Faculty of dental sciences, B- Block Sgt dental college, Gurgaon - Badli Road chandu Budhera, Gurugram - Haryana 122505.
Gurgaon- Badli Road Chandu, Budhera, Gurugram - Haryana 122505
Gurgaon
HARYANA
122505
India 
Phone  9013290054  
Fax    
Email  shalinikapoor_fds@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Pranjal Gaba  
Designation  Intern 
Affiliation  SGT Dental College 
Address  Room Number - 011, Department of Periodontology, Faculty of dental sciences, B- Block Sgt dental college, Gurgaon - Badli Road chandu Budhera, Gurugram - Haryana 122505.
Room Number - 011, Department of Periodontology, Faculty of dental sciences, B- Block Sgt dental college, Gurgaon - Badli Road chandu Budhera, Gurugram - Haryana 122505.
Gurgaon
HARYANA
122505
India 
Phone  8607004786  
Fax    
Email  pranjalgaba11@gmail.com  
 
Source of Monetary or Material Support  
SGT Dental Hospital, Room Number - 011, Department of Periodontology, Faculty of dental sciences, B- Block Sgt dental college, Gurgaon - Badli Road chandu Budhera, Gurugram - Haryana 122505.  
 
Primary Sponsor  
Name  Pranjal Gaba 
Address  Gurgaon- Badli Road Chandu, Budhera, Gurugram - Haryana 122505 
Type of Sponsor  Other [self] 
 
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 
pranjal gaba  SGT Dental College & Hospital   Room Number - 011, Ground Floor, Department of Peridontology Faculty of dental sciences. Budhera, Gurugram, Haryana
Gurgaon
HARYANA 
8607004786

pranjalgaba11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - SGT Dental College, Hospital and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  People undergoing Dental Implant therapy in the oral cavity  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group   In this normal wash nothing will be given , 5ml normal wash with frequency of one time only  
Intervention  Neem Mouthwash & Chlorhexidine  5% herbal neem mouthwash, 5ml Frequency - one time & 0.2% chlorhexidine, 5ml dosage Frequency - One time 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  54.00 Year(s)
Gender  Both 
Details  Patients with minimum 20 number of teeth and of both the sexes rangimg from age 30-54 years were included. It also include patients who are systemically healthy.  
 
ExclusionCriteria 
Details  It will include systemically unhealthy patiennts, smokers and patients who are allergic to any content of chlorhexidine mouthwash.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
5% neem mouthwash -m After using it we will observe the bacterial count whether it is reduces or not, we will see what changes occur after the application of the mouthwash   5% neem mouthwash  
 
Secondary Outcome  
Outcome  TimePoints 
0.2% chorhexidine   24 hours and colony forming unit will be counted with naked eye  
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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 1/ Phase 2 
Date of First Enrollment (India)   07/02/2024 
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="0"
Months="0"
Days="15" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pranjalgaba11@gmail.com].

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 01-01-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - none
Brief Summary  

The Oral cavity is naturally wet and contains a high number of microorganisms. Despite that, lack of precision around what is known and unknown regarding aerosol generation in dentistry and there is possibility of wish to patient and the dental team. It can be shared where transmission may occur from patient - to – patient, patient – to – clinician, or clinician – to – patient. All the procedures in the dental clinic involve working of high-speed devices with compressed air and water, as a result producing splatter and aerosol. Suspension of solid or liquid particles containing microorganisms like bacteria and viruses in air for few minutes is termed as Aerosol. Different methodologies, materials and antimicrobial agents have been advocated to minimize the microbial cross-contamination in the dental office. Few recommendations include, immunization of dental staff, decontamination of surfaces, sterilization of instruments, use of personal protective barriers and the use of pre-procedural mouthwashes. Chlorhexidine (CHX) is reviewed as the gold standard in limiting oral biofilm growth and also in reducing microbial spread due to its wide antibacterial spectrum and substantivity of 8 to 12 hours. There is a recent trend in the use of herbal mouthwashes. Neem has been traditionally used of for the treatment of inflammation, infection, fever, skin diseases and dental problems. Neem leaves have been reported to also possess antihyperglycemic, immunomodulatory, anti-inflammatory, antimalarial, anti-oxidant, antiviral, antimutagenic and anticarcinogenic properties. To the best of our knowledge studies have only been done on aerosol production during ultrasonic scaling and other high speed devices employing water sprays but not implant treatments. The present study is new of its kind as it will evaluate and compare the effect of chlorhexidine mouthwash and neem mouthwash as a preprocedural mouth rinse on bioaerosol production in patients undergo implant therapy. A clinic- microbiological study. The pilot study is a randomized controlled trial.  Total 21 patients will be selected who had to undergo implant placement were selected based on specific inclusion and exclusion criteria from the Out Patient Department of Department of Periodontology and Oral Implantology,  Faculty of dental sciences, SGT Dental College, Gurugram, Haryana. The study will be approved by the Institutional Ethics Committee. Patients will be informed about the study and a written informed consent will be taken from subjects selected. Complete medical and dental history will be recorded of the patients selected. Patients with minimum 20 number of teeth and of both the sexes ranging from age 30-54 years were included. Exclusion criteria will include systemically unhealthy patients, smokers and patients who are allergic to any content of Chlorhexidine mouthwash. Inclusion criteria included patients who are systemically healthy.

The patients undergoing implant placement were divided into three groups randomly –

·       Group I: CHLOREHIXIDINE RINSING - This group comprised of 07 patients, who rinsed with 0.2% of chlorhexidine mouthwash – 10 ML for 30 seconds before the osteotomy drilling procedure for implant.

·       Group II: NEEM SOLUTION - The group comprised of 07 patients, who rinsed with approved neem solution prepared – 10 ML for 30 seconds before the osteotomy drilling procedure for implant.

·       Group III: CONTROL - The group consisted of 07 patients, as control.

Prior to the Implant placement procedure, the Implant Operation theatre will be well fumigated with Formaldehyde. Red blood agar culture plates would be positioned at fixed areas within the Implant OT. The patient undergoing the treatment will be given local anesthesia and will be made to rinse with commercially available 0.2% Chlorhexidine Gluconate (Dr Reddy’s® ) maintaining at room temperature in case  the patient belonging to the Group I and the patient belonging to Group II will be made to rinse self-prepared neem mouthwash and the patient belonging to the Group III will not be rinsing. The plates will be numbered 1,2,3,4,5,6,7 for all the patients, A standardized distance, which is the mean of distance from two fixed points in all patients will be considered, measuring from the patient will be maintained throughout the study. The lids of the blood agar plates will be opened once the osteotomy will be initiated and closed as soon as the osteotomy will be completed. All the splatter and aerosol will be collected which will fell during the procedure naturally as a result of gravity, within the plates during the procedure and will be sent for incubation at 37 degrees Celsius for 24 hours to the Department of Microbiology, SGT Medical Hospital. The plates will be withdrawn from the incubation chamber after 24 hours and colony forming unit will be counted with naked eye.

 

The study has various beneficial clinical implication.

1.    Use of chlorhexidine mouthwash and neem mouthwash as a preprocedural rinse in implant patients.

2.    Reduction in bioaerosol in aerosol generating implant procedure.

3.    Decreased rise of cross-contamination.

Th purpose of this trial is to complete my study of ICMR - STS PROJECT which is selected and to find out the microorganisms which is caused in Implant cases.

 
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