| CTRI Number |
CTRI/2025/07/091508 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of a gel containing Manuka Honey and Vitamin C on healing of post extraction wound : A Randomized control study |
|
Scientific Title of Study
|
Efficacy of a Mucoadhesive gel containing Manuka Honey and Vitamin C on healing of post extraction wound : A Randomized control 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 |
Vinita Patil |
| Designation |
Junior Resident |
| Affiliation |
goverment dental college and hospital |
| Address |
102 Dnyan Darshan Niwas Near Hanuman Mandir Dativali Goan Diva St. Georges Hospital Compound Pdmello road Fort 400001 Mumbai MAHARASHTRA 400612 India |
| Phone |
9892360408 |
| Fax |
|
| Email |
vinitapatil1910@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Samir Khaire |
| Designation |
Associate professor |
| Affiliation |
Government dental college and hospital |
| Address |
St. Georges Hospital Compound Pdmello road Fort 400001
Mumbai MAHARASHTRA 400001 India |
| Phone |
9767887203 |
| Fax |
|
| Email |
sameerdkhaire@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Vinita Patil |
| Designation |
Junior resident |
| Affiliation |
Government dental college and hospital |
| Address |
102 Dnyan Darshan Niwas near Hanuman Mandir Dativali Goan Diva
Mumbai MAHARASHTRA 400612 India |
| Phone |
9892360408 |
| Fax |
|
| Email |
vinitapatil1910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Samir Khaire, Associate professor , Dept. of Oral and maxillofacial surgery, GDC and H ,Mumbai |
| Dr. Vandana Panda,K M Kundani college of pharmacy |
| Mobeen Shaikh, K M Kundani college of Pharmacy |
|
|
Primary Sponsor
|
| Name |
GDC AND H Mumbai |
| Address |
St. Georges Hospital Compound Pdmello road Fort 400001 |
| Type of Sponsor |
Other [Government dental college ] |
|
|
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 Vinita Patil |
118,dept. of Oral and Maxillofacial Surgery, Government Dental College and Hospital |
St. Georges Hospital Compound Pdmello road Fort 400001 Mumbai MAHARASHTRA |
9892360408
vinitapatil1910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Government Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with carious and periodontally compromised teeth and require extraction |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: manuka honey and vit. c gel , Reference: manuka honey , Route: Topical, Dosage Form: Kalka/ Paste , Dose: 1(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: its a gel placed in socket post extraction |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients indicated for bilateral extraction.
2. Patients not suffering from any Co-morbidities.
3. ASA category -I patient
|
|
| ExclusionCriteria |
| Details |
1. Patients with acute dental infection.
2. Immunocompromised patients.
3. Pregnant & lactating female patient
4. patient currently on medication for any medical condition
5. ASA category- II, III, IV
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain on VAS
2. Extraoral Swelling
3. wound healing
|
Day 1
day 3
day 7
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inflammatory marker: CRP |
day 1
day 3
day 7 |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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="0" 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
|
Tooth extraction or Dental extraction is a procedure done by the dentist for removal of a tooth from the dental socket. Inflammation and Infection occur by the bacteria, microbes, and fungi which leads to pain, redness, swelling, chronic infection, and severe bleeding. Dental sockets undergo several ordered events during the healing process, including inflammation, overlapping stages of haemostasis, remodelling, and maturation. After a teeth extraction, there may be post-operative complications, such as pain and swelling, which could last for several days. To reduce these problems and accelerate healing, various systemic drugs, natural products, preservative materials, and irrigation techniques to be used. Tooth extraction often leads to an open wound that requires effective and rapid healing to prevent complications such as infection, delayed recovery, and patient discomfort. Traditional treatments like zinc oxide and eugenol provide antimicrobial and soothing effects, but they often lack additional bioactive components that actively promote tissue regeneration and accelerated healing. Manuka honey, with its potent antibacterial and anti-inflammatory properties, combined with vitamin C, a well-known antioxidant that supports collagen synthesis and tissue repair, presents a promising alternative for enhancing post-extraction wound healing. Moore showed that Manuka honey has “very special healing properties” and described it as “the best natural antibiotic in the world.” It was found that the topical application of honey clears existing wound infection rapidly; facilitates healing of deeply infected surgical wounds; and halts spreading necrotizing fasciitis.4 It has also promoted healing of infected wounds that were not responding to conventional therapy such as antibiotics and antiseptics, including wounds that were infected with antibiotic-resistant bacteria such as methicillin-resistant Staphyloccocus aureus (MRSA). Vitamin C, also known as ascorbic acid (vit.c), was shown to modify the epigenetic/gene expression profile and extracellular matrix. Vitamin C contributes to the health of the cardiovascular, immunological and nervous system and also supports healthy bone, lung, and skin function and wound healing. The mechanism of action of vitamin C in human health is as diverse as its targets and effects. For example, vitamin C functions as an antioxidant, signals changes in gene expression, plays a role in protein metabolism, and serves a cofactor in several biosynthetic pathways including collagen synthesis. The role of vitamin C in support of improved wound healing during the re-epithelialization stage. While vitamin C supports wound healing in early stages by reducing inflammation, vitamin C continues to support wound healing by promoting collagen synthesis and epithelial cell migration in the re-epithelialization stage. Presently, the most effective post-operative care for tooth extraction is systemic antibiotic and analgesics to eradicate inflammation & prevent infections. To enhance the local drug delivery, the concept of muco-adhesion is being introduced. Thus, a formulation in the form of gel can be considered appropriate for healing of tooth extraction socket. Considering that the systemic medication cause several side effects, this study will evaluate efficacy of a gel to eradicate inflammation & prevent infections, thereby avoiding side effect of systemic medications. |