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CTRI Number  CTRI/2025/02/080132 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Antibacterial effect of mouthwash containing plum seed extract on dental decay producing bacteria in patients undergoing fixed braces treatment.  
Scientific Title of Study   Comparative evaluation of antimicrobial activity of Plum seed extract mouthwash against streptococcus mutans and Lactobacillus acidophillus in patients undergoing fixed orthodontic treatment - A randomised controlled clinical 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  KAVALI STANLEY 
Designation  post graduate student 
Affiliation  SRM Dental College 
Address  Room no.9, Department of orthodontics, 2nd floor, SRM Dental College, No.30,Bharathi Salai,Ramapuram,Chennai TAMIL NADU 600089 India

Chennai
TAMIL NADU
600089
India 
Phone  7989107791  
Fax    
Email  noelstanley1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeetha Duraisamy 
Designation  professor 
Affiliation  SRM dental college 
Address  ROOM NO.9, Department of orthodontics, 2nd floor, SRM Dental college. No.30,Bharathi salai , Ramapuram,Chennai TAMIL NADU 600089 India

Chennai
TAMIL NADU
600089
India 
Phone  9789000386  
Fax    
Email  sangeetha.guhan@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sangeetha Duraisamy 
Designation  professor 
Affiliation  SRM dental college 
Address  ROOM NO.9, Department of orthodontics, 2nd floor, SRM Dental college. No.30,Bharathi salai , Ramapuram,Chennai TAMIL NADU 600089 India

Chennai
TAMIL NADU
600089
India 
Phone  9789000386  
Fax    
Email  sangeetha.guhan@yahoo.com  
 
Source of Monetary or Material Support  
SRM Dental College, No30, Bharathi salai, Ramapuram, Chennai -600089 
 
Primary Sponsor  
Name  NIl 
Address  NA 
Type of Sponsor  Other [Self Funded study ] 
 
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 KAVALI STANLEY  SRM Dental College  Room no.9, Department of orthodontics, 2nd floor, SRM Dental College, No.30,Bharathi Salai,Ramapuram,Chennai TAMIL NADU 600089 India
Chennai
TAMIL NADU 
7989107791

noelstanley1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRMDCIRB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No mouthwash   Group IV patients will not use any mouthwash after brushing  
Intervention  rinsing with mouth wash containing 2% and 5% plum seed extract   patients undergoing fixed orthodontic treatment will be instructed to use the mouthwash containing plum seed extract. Preparation of mouthwash with plump seed extract – Plum fruits (Prunus domestica) will be purchased from local market of Chennai, India. The collected fruits will be cut and the seeds will be separated and dried and ground into fine powder using an electric mill. 2% plum seed mouthwash containing 2000 microgram of plum seed extract in one ml of mouth wash will be prepared. by mixing 200 mg of the plum seed powder in 100 ml of distilled water in a in a sterile beaker and placing on a hot plate magnetic stirrer at 60°C. Th homogeneous solution obtained will be diluted with 900 mL of distilled water was further added to obtain a final Volume of 1000 ml and stored in light proof bottles in refrigerator. 10 5% plum seed mouthwash containing 5000 microgram of plum seed extract in one ml of mouth wash will be prepared. by mixing 500 mg of the plum seed powder in 100 ml of distilled water in a in a sterile beaker and placing on a hot plate magnetic stirrer at 60°C. Th homogeneous solution obtained will be diluted with 900 mL of distilled water was further added to obtain a final Volume of 1000 ml and stored in light proof bottles in refrigerator. 10 Group I patients will be instructed to rinse the mouth with 2% plum seed extract mouth wash , Group II patients with 5% plum seed extract mouth wash twice daily after brushing. 
Comparator Agent  0.12% chlorhexidine mouth wash  Group III patients will be instructed to rinse their mouth with 0.12% chlorhexidine mouthwash twice a day after brushing Composition of chlorhexidine mouthwash  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patients with full complement of teeth in permanent dentition (excluding third molars)
DMFT score nor greater than 2
Gingival index (Loe ) score less than 1
Will undergo treatment with 022” slot MBT prescription stainless steel orthodontic brackets (Mini diamond, Ormco corporation, California, USA) with initial archwires tied to the bracket slots with elastomeric ligatures
Who are willing to give informed consent to participate in the study
 
 
ExclusionCriteria 
Details  Smoking habit ,
patients under antibiotic therapy
Systemic disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Streptococcus mutans and Lactobacillus acidophilus count in dental plaque of patients belonging to the four study groups   1st month,3rd month,6th month after the beginning fixed appliance treatment

 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   15/02/2025 
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="0"
Months="10"
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  

The study aims to evaluate and compare the antimicrobial activity of 2% and 5% plum seed extract mouthwash with 0.12% chlorhexidine mouthwash and a control group without mouthwash against Streptococcus mutans and Lactobacillus acidophilus in the dental plaque of patients undergoing fixed orthodontic treatment. Patients aged over 18 years, enrolled for fixed orthodontic treatment without therapeutic extractions, and meeting the inclusion criteria, will be randomly assigned to the four study groups using a computer-generated random chart with allocation concealment through sealed envelopes. Inclusion criteria include patients with a full complement of permanent teeth (excluding third molars), a DMFT score not exceeding 2, a gingival index (Löe) score of less than 1, and those undergoing treatment with 0.022-inch slot MBT prescription stainless steel orthodontic brackets (Mini Diamond, Ormco Corporation, California, USA), with initial archwires tied to the bracket slots using elastomeric ligatures. Participants must also be willing to provide informed consent. Exclusion criteria include smoking habits, current antibiotic therapy, and systemic diseases. Plum seed extract mouthwash will be prepared following established protocols in the literature, while the 0.12% chlorhexidine mouthwash (Perioguard, Colgate Palmolive, India) will be procured without any additional antimicrobial agents. All patients will undergo oral prophylaxis before appliance bonding and will receive uniform oral hygiene and diet instructions. Each patient will be provided with a medium-texture orthodontic toothbrush and non-fluoridated, non-medicated toothpaste, with instructions to brush twice daily for at least three minutes. Group I will use 2% plum seed extract mouthwash, Group II will use 5% plum seed extract mouthwash, Group III will use 0.12% chlorhexidine mouthwash, and Group IV will serve as the control without any mouthwash instructions. A compliance chart will be provided to all patients, who will document mouthwash use, and the chart will be reviewed at each visit. Samples will be collected at 1, 3, and 6 months post-appliance bonding. Supra-gingival plaque samples will be collected from the right lateral incisor using a 4-pass technique during early morning appointments, with patients instructed not to brush their teeth on the day of collection. These samples will be transferred to vials containing appropriate media, transported to the laboratory, and evaluated for Streptococcus mutans and Lactobacillus acidophilus counts. Colony counts will be measured using a colony counter, and the results will be expressed in CFU/mL.

 
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