| CTRI Number |
CTRI/2026/02/103760 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of hydrogen peroxide lactoferrin zinc lactate mouthwash and povidone iodine mouthwash on healing after periodontal surgery |
|
Scientific Title of Study
|
Comparative evaluation of mouthwash containing 0.1% Hydrogen Peroxide, 0.05% lactoferrin and 0.14% zinc lactate with 2% povidone iodine on clinical healing outcomes following periodontal surgery A Randomised controlled 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 |
DR SUJAY J |
| Designation |
POST GRADUATE STUDENT PERIODONTOLOGY |
| Affiliation |
AJ INSTITUTE OF DENTAL SCIENCES |
| Address |
TEJASU 2ND CROSS MARNAMIBAIL TEMPO STAND DOWN SHIVAMOGGA
Dakshina Kannada
KARNATAKA
577201
India |
| Phone |
9036976887 |
| Fax |
|
| Email |
sujayj72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAHANA PURUSHOTHAM |
| Designation |
READER |
| Affiliation |
AJ INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY AJ INSTITUTE OF DENTAL SCIENCES NH66 KUNTIKAN MANGALURU
Dakshina Kannada
KARNATAKA
575008
India |
| Phone |
9591293604 |
| Fax |
|
| Email |
purushothamsahana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUJAY J |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
AJ INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY AJ INSTITUTE OF DENTAL SCIENCES NH66 KUNTIKAN MANGALURU
Dakshina Kannada
KARNATAKA
575008
India |
| Phone |
9036976887 |
| Fax |
|
| Email |
sujayj72@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GROUP PHARMACEUTICALS |
| Address |
RAJAJINAGAR BENGALURU 560010 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 SUJAY J |
AJ INSTITUTE OF DENTAL SCIENCES |
DEPARTMENT OF PERIODONTOLOGY
Dakshina Kannada
KARNATAKA |
9036976887
sujayj72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AJIDS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrogen peroxide lactoferrin zinc lactate mouthwash VS
Povidone iodine mouthwash |
Group A patients will receive mouthwash containing 0 point 1 percent hydrogen peroxide 0 point 05 percent lactoferrin and 0 point 14 percent zinc lactate. Patients will be instructed to use 10 ml of mouthwash for 30 seconds two times daily for 21 days after periodontal surgery.
Group B patients will receive 2 percent povidone iodine mouthwash. Patients will be instructed to use 10 ml of mouthwash for 30 seconds three times daily for 21 days after periodontal surgery.
Patients will be randomly allocated into two groups using computer generated randomization. The study will follow double blinding where both patient and examiner will not know the allocated mouthwash. Mouthwashes will be dispensed in coded amber bottles. |
| Comparator Agent |
Povidone iodine mouthwash 2 percent |
Patients in comparator group will receive 2 percent povidone iodine mouthwash. Patients will be instructed to use 10 ml mouthwash for 30 seconds three times daily for 21 days after periodontal surgery. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 35 to 55 years
Systemically healthy patients
Diagnosed with stage three grade B periodontitis
Completed nonsurgical periodontal therapy at least three months before surgery
Indicated for periodontal flap surgery without regenerative procedures
Non smokers
Patients willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases affecting wound healing such as diabetes mellitus or severe anemia
Patients who used systemic antibiotics in last six months
Patients taking medications affecting healing such as corticosteroids or cytotoxic drugs
Smokers
Pregnant or breastfeeding women
Patients requiring regenerative periodontal surgery
Patients not willing to follow study protocol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing outcome measured using the Healing Index (Landry et al 1988)
Tissue colour
Bleeding on palpation
Granulation tissue
Incision margin epithelialization
Presence of suppuration |
BASELINE AND 21DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient-reported pain discomfort measured using Visual Analogue Scale (VAS)
Evaluated at Baseline
Evaluated at 21 days post-operatively |
BASELINE AND 21DAYS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
This study aims to compare the effect of two postoperative mouthwashes on healing after periodontal surgery. One mouthwash contains 0 point 1 percent hydrogen peroxide 0 point 05 percent lactoferrin and 0 point 14 percent zinc lactate and the other contains 2 percent povidone iodine. Twenty systemically healthy patients with stage three grade B periodontitis who require periodontal surgery will be included in the study. Patients will be randomly divided into two groups using computer generated randomization. The study will follow a double blinding method where both the patient and examiner will not know which mouthwash is given. The mouthwashes will be dispensed in coded amber bottles. Patients will use the assigned mouthwash for twenty one days after surgery. Clinical healing will be evaluated using healing index and patient pain will be assessed using visual analogue scale at baseline and after twenty one days. The results of this study may help in selecting an effective postoperative mouthwash for better periodontal healing outcomes. |