| 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
|
|
|
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
|
|
|
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. |
|
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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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pranjalgaba11@gmail.com].
- 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.
- 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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