| 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
|
|
|
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
|
|
|
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. |