| CTRI Number |
CTRI/2026/02/103317 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Saliva Changes with Mouthwashes in Braces Patients |
|
Scientific Title of Study
|
A Comparative Evaluation of the Effects of Three Different Mouthwashes on Salivary pH of the Oral Cavity in Fixed Orthodontic Patients – A Randomized Clinical Trial |
| Trial Acronym |
Cute-PH trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sruthi J |
| Designation |
MDS Assistant professor |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Room no :7,second floor, Department of orthodontics and dentofacial orthopaedics,Adhiparasakthi dental college and hospital,Melmaruvathur,Kancheepuram district,Tamil nadu ,603319,INDIA.
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9360756125 |
| Fax |
|
| Email |
sruthijeevagan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sruthi J |
| Designation |
MDS Assistant professor |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Room no :7,second floor, Department of orthodontics and dentofacial orthopaedics,Adhiparasakthi dental college and hospital,Melmaruvathur,Kancheepuram district,Tamil nadu ,603319,INDIA.
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9360756125 |
| Fax |
|
| Email |
sruthijeevagan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sruthi J |
| Designation |
MDS Assistant professor |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Room no :7,second floor, Department of orthodontics and dentofacial orthopaedics,Adhiparasakthi dental college and hospital,Melmaruvathur,Kancheepuram district,Tamil nadu ,603319,INDIA.
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9360756125 |
| Fax |
|
| Email |
sruthijeevagan@gmail.com |
|
|
Source of Monetary or Material Support
|
| H. No. 8-2-293/82/JIII, Plot No. 415, 4th Floor, 403, Apurupa LNG, Rd. 78, Jubilee Hills, Hyderabad, Telangana, 500033, India.
|
|
|
Primary Sponsor
|
| Name |
Lasarkaali pvt ltd |
| Address |
H. No. 8-2-293/82/JIII, Plot No. 415, 4th Floor, 403, Apurupa LNG, Rd. 78, Jubilee Hills, Hyderabad, Telangana, 500033, India. |
| Type of Sponsor |
Other [Neutraceutical company] |
|
|
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 |
| DrSruthi Jeevagan |
Adhiparasakthi Dental college and Hospital |
Room no :7,second floor, Department of orthodontics and dentofacial orthopaedics,Adhiparasakthi dental college and hospital,Melmaruvathur,Kancheepuram district,Tamil nadu ,603319,INDIA.
Kancheepuram
TAMIL NADU |
09360756125
sruthijeevagan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Adhiparasakthi Dental college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers reported in outpatient department in orthodontics selected in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Hetafu mouthwash
|
Group A Participants were instructed to rinse with 10–15 ml of Hetafu mouthwash twice daily for 30 seconds for 1 weeks.
|
| Comparator Agent |
Group B Chlorhexidine mouthwash
Group C Listerine mouthwash |
Group B Participants instructed to rinse with 10–15 ml of chlorhexidine mouthwash twice daily for 30 seconds for 1 week (7 days).
Group C Participants instructed to rinse with 10–15 ml of Listerine mouthwash twice daily for 30 seconds for 1 week (7 days). |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 12–30 years undergoing fixed orthodontic treatment.
Patients with full-mouth fixed orthodontic appliances in both arches.
Patients who have been undergoing fixed appliance therapy for a minimum of 3 months.
Patients with good general health and no known systemic diseases affecting salivary secretion or pH.
Patients with normal salivary flow rate.
Patients with good oral hygiene and no active oral infections at the time of sample collection.
Patients willing to use the allocated mouthwash according to the study protocol.
Patients who provide written informed consent (and parental consent for minors). |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases (e.g., diabetes, Sjögren’s syndrome) or conditions affecting salivary flow or composition.
Patients taking medications that alter salivary flow or pH (e.g., antidepressants, antihistamines).
Patients with active dental caries, periodontal disease, or oral lesions.
Patients using any mouthwash, probiotic, or fluoride rinse other than the study mouthwash during the study period.
Patients with removable orthodontic appliances or aligners.
Patients who have undergone professional oral prophylaxis within the previous 2 weeks.
Patients with a history of allergy or sensitivity to any ingredient in the study mouthwashes.
Patients who are uncooperative or unwilling to comply with study instructions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure was the difference in salivary pH levels measured at baseline and after the intervention period among the three mouthwash groups. |
T0: Baseline
T1: Immediately after first use (after 5 minutes)
T2: After 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome was the comparison of salivary pH changes among the three mouthwash groups over time. |
T0: Baseline
T1: Immediately after first use (after 5 minutes)
T2: After 1 week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2026 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Submitted the manuscript in the journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Title of the study:
A Comparative Evaluation of the Effects of Three Different Mouthwashes on Salivary pH of the Oral Cavity in Fixed Orthodontic Patients – A Randomized Clinical Trial (SMILE Trial) Introduction: Orthodontic appliances have been reported to influence salivary composition and properties, including alterations in pH and buffering capacity, which may increase the vulnerability of patients to caries development. In addition to mechanical plaque control, mouthwashes and other chemical agents are frequently advised to improve oral hygiene in orthodontic patients. This randomized clinical experiment assess and compare the effects of three distinct mouthwashes on the salivary pH level in patients receiving fixed orthodontic therapy. Methods: This randomized parallel-group single-blind clinical trial involved 120 patients who attended fixed orthodontic treatment, randomly divided into three groups (n = 40 each): Hetafu, chlorhexidine, and Listerine mouthwash users. Every participant received two 10-15 ml rinses per day, each of which lasted 3060 seconds. Saliva pH was measured using standard pH paper at baseline, directly after the mouthwash use (five minutes), and after one week from the beginning of the intervention. The results were analyzed using a repeated-measures ANOVA with Greenhouse-Geisser correction and Bonferroni post-hoc comparisons with p < 0.05 level of significance. Results: Of the 120 participants, forty were assigned to every mouthwash group. The initial pH of saliva was comparable between the groups (p = 0.157). After five minutes, Hetafu had a considerably higher pH (7.75% +/- 0.78%) than the other two products, namely chlorhexidine (7.08% +/- 1.00%) and Listerine (7.15% +/1.37%) (p = 0.014). After one week, Hetafu’s pH increased to 7.93% +/- 0.69%, whereas those of chlorhexidine (6.78% +/- 0.80%) and Listerine (6.70% +/- 1.34%) decreased (p < 0.001). Within-group comparison also revealed an increase in pH following the use of Hetafu (p < 0.001). However, there was no considerable change for the Listerine group (p = 0.182). Bonferroni-adjusted pairwise comparisons also showed that Hetafu’s pH is considerably higher than that of chlorhexidine (p = 0.006). Additionally, it was higher than that of Listerine (p = 0.023). Conclusion: Within the scope of the study, the Hetafu mouth rinse showed a more pronounced and prolonged increase in saliva pH compared to Listerine and chlorhexidine. This characteristic may contribute to the maintenance of oral pH homeostasis and prevention of enamel demineralization and white spot lesions. |