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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patients with carious and periodontally compromised teeth and require extraction  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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.

 

 
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