| CTRI Number |
CTRI/2025/04/084961 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of local placement of vitamin E in reducing post operative pain during multiple lower jaw teeth removal |
|
Scientific Title of Study
|
The effect of intra-socket Vitamin E placement in reducing dry socket occurance and postoperative pain in multiple mandibular extractions: A split-mouth triple blinded randomized control 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 |
ANAMIKA K S |
| Designation |
MDS Student - Oral and Maxillofacial Surgery |
| Affiliation |
|
| Address |
Room no 6, 1st floor,
Department of Oral and Maxillofacial Surgery,
Sri Ramachandra Dental College, Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9952462373 |
| Fax |
|
| Email |
anamika.sasidharan333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PEARLCID SIRORAJ |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Room no 6, 1st floor,
Department of Oral and Maxillofacial Surgery
Sri Ramachandra Dental College, Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9791116178 |
| Fax |
|
| Email |
pearlcid@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANAMIKA K S |
| Designation |
MDS Student - Oral and Maxillofacial Surgery |
| Affiliation |
|
| Address |
Room no 6, 1st floor,
Department of Oral and Maxillofacial Surgery
Sri Ramachandra Dental College, Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9952462373 |
| Fax |
|
| Email |
anamika.sasidharan333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research Porur Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
ANAMIKA K S |
| Address |
Room no 6, 1st floor,
Department of Oral and Maxillofacial Surgery
Sri Ramachandra Dental College, Porur
Chennai 600116 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 ANAMIKA K S |
Sri Ramachandra Institute of Higher Education and Research |
Room no 6 2nd Floor Department of Oral and Maxillofacial Surgery
Sri Ramachandra Dental College Porur
Chennai
Chennai
TAMIL NADU |
9952462373
anamika.sasidharan333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SALINE |
SALINE SOAKED GEL-FOAM IS USED AS PLACEBO IN THIS STUDY |
| Intervention |
VITAMIN E |
A gel foam will be cut into 1x1 cm and soaked in Vitamin E 40 IU soft gels (manufactured by Procter and Gamble Health Ltd under the trade name - Evion) squeezed out and packed and placed in the extracted socket on one side and kept in place using figure of 8 suture. The post operative healing and pain will be assessed on 3rd , 7th and 14th post operative day.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Males and females aging 20 to 40. (to ensure that none of the post-menopausal since oestrogen and progesterone are important variables of dry socket)
Patients with need of bilateral mandibular teeth extractions.
Complaince with all requirements in the study and signing the informed consen. |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases that may affect the outcomes of the study such as uncontrolled diabetes, hyperthyroidism , hyperparathyroidism, paget’s disease also diseases affecting bone
healing , includes osteoporosis ,rickets ,and osteomalacia .
Patients on chronic medications affecting the periodontal status such as anticonvulsant , calcium channel blockers ,immunosuppressive , anti-inflammatory medications.
Pathological lesions at the site of impaction.
Patients with history of smoking , alcohol consumption, lactating mothers.
Patients currently on radiotherapy and or chemotherapy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain evaluation is done using visual analog scale and
overall healing is evaluated using Laundry et al.
The assessment was done for the presence or absence of signs and symptoms of dry socket including halitosis, foul taste, socket devoid of clot with exposed bone that may be filled with food debris, edema of the surrounding gingiva, and regional lymphadenitis. |
3rd , 7th , 14th post operative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief and reduced rate of post operative complication |
3rd, 7th , 14th post operative day |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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)
|
01/05/2025 |
| 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="6"
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
|
Vitamin E is a lipid soluble basic vitamin and consists of two subgroups: tocopherol and tocotrienol. Vitamin E is the collective name for a group of fat soluble compounds with distinctive antioxidant activities. Naturally occurring vitamin E exists in eight chemical forms (alpha, beta , gamma , and delta tocopherol that have varying levels of biological activity. Dry socket (alveolar osteitis) is the presence of postoperative pain in and around the extraction site that worsens 1 to 3 days after the extraction followed by a partially or completely disintegrated blood clot within alveolar socket with or without halitosis.The primary aim of this cinical trial is to evaluate the effectiveness of intra socket vitamin E in reducing post operative pain and incidence of dry socket in bilateral mandibular extractions.The present split-mouth study is a prospective triple blinded clinical trial of sample size of 59 patients. We will be selecting patients reporting to Oral and Maxillofacial Surgery department requiring with bilateral mandibular extractions. One side of the extractions in mandible will be randomly assigned to the test group , where a piece of gel foam will be cut into 1 cm2 and soaked in Vitamin E 400 IU soft gels squeezed out and packed whereas contralateral socket served as the control group will be receiving a placebo. The placebo will be a 1 cm2 gel form soaked in saline and placed in the control group. Patient will be recalled on 3rd, 7th, and 14th day for evaluation of post operative healing and pain, incidence of dry socket. Post operative pain evaluation is done using visual analog scale and overall healing is evaluated using Laundry et al. The assessment was done for the presence or absence of signs and symptoms of dry socket including halitosis, foul taste, socket devoid of clot with exposed bone that may be filled with food debris, edema of the surrounding gingiva, and regional lymphadenitis.
Case - Vitamin E soaked gel form placed on one side of mandible Control - Placebo using Saline soaked gel form placed on other side of mandible Blinding 1. Patient 2. Operator 3. Accessor |