| CTRI Number |
CTRI/2026/01/100557 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Vitamin C and Healing After Wisdom Tooth Removal |
|
Scientific Title of Study
|
Comparative Evaluation of the Efficacy of Vitamin C Tablets in Wound Healing
after Surgical Extraction of Mandibular Third Molars-A Split Mouth Randomized 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 Tajane Mayur Kailash |
| Designation |
3rd year Post graduate Student |
| Affiliation |
Nair Hospital Dental College |
| Address |
Nair Hospital Dental College
Dr.AL Nair Road,Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9326006976 |
| Fax |
|
| Email |
mayurtajane2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tajane Mayur Kailash |
| Designation |
|
| Affiliation |
Nair Hospital Dental College |
| Address |
Nair Hospital Dental College
Dr.AL Nair Road,Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9326006976 |
| Fax |
|
| Email |
mayurtajane2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tajane Mayur Kailash |
| Designation |
3rd year Post graduate Student |
| Affiliation |
Nair Hospital Dental College |
| Address |
Nair Hospital Dental College
Dr.AL Nair Road,Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9326006976 |
| Fax |
|
| Email |
mayurtajane2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nair Hospital Dental College - 55, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra, India- 400008 |
|
|
Primary Sponsor
|
| Name |
Nair Hospital Dental College |
| Address |
55, Dr Anandrao Nair Marg, , Mumbai Central, Mumbai, Maharashtra, 400008 |
| Type of Sponsor |
Government medical 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 |
| DrTajane Mayur Kailash |
Nair Hospital Dental College |
Department of Oral and Maxillofacial Surgery- Room no-107, 1st floor
Mumbai
MAHARASHTRA |
9326006976
mayurtajane2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC NHDC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vitamin C tablets |
Vitamin C 500mg chewable tablets thrice a day for 14 days will be taken by patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients indicated for surgical extraction of Mesioangularly impacted
bilateral mandibular third molars
2. Patients willing to participate in the study
3. Patients aged 18-50 years of age
4. Patients without any history of chronic illness |
|
| ExclusionCriteria |
| Details |
1. Patients who gives a previous history of allergic reactions like
fever,rash,itching,headache,breathing difficulty after the consumption of any
antibiotics, analgesics and Vitamin C tablets or any citrus fruits like
lemon,orange.
2. Patients with renal dysfunction, liver disorder, asthma,pregnancy or any
other systemic abnormality.
3. Patients with an intellectual deficit. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Vitamin C tablets in accelerating wound healing
post surgical extraction of mandibular 3rd molars. |
Clinical examination at 7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Vitamin C tablets in reducing post extraction pain
and complications after surgical extraction of mandibular 3rd molars. |
Clinical examination at 7th and 14th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="0"
Months="11"
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 will include patients indicated for bilateral surgical extraction of mesioangularly impacted mandibular third molar, selected from the Oral and Maxillofacial Surgery OPD. A detailed case history will be recorded, with emphasis on prior allergic reactions to antibiotics, analgesics, vitamin C or citrus fruits. Preoperative evaluation will involve OPG, blood investigation, after obtaining written informed consent. The study follows a split mouth design where each patient serves as both control and study group. Surgical extractions will be performed under Local anaesthesia by a single operator under sterile conditions. Standard post operative instructions will be given and all patients will receive T. Augmentin 625mg BID, T. Diclopara TDS, T. Pan 40 OD for 3 days. Literature indicated no drug interactions between vitamin c and these medications. In control phase no vitamin C supplementation will be prescribed. 1 month later, contralateral tooth will be extracted in an experimental phase during which patient will receive vitamin c chewable tablets TDS for 14days. Follow up will be on post operative day 7 and 14 in both phases. Clinical assessment will include pain evaluation using VAS scale and wound healing using Landry healing index. |