| CTRI Number |
CTRI/2024/11/077011 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating Shyama Tulsi Extract with Calcium Sulphate Hemihydrate as a Natural Alternative to Antibiotics and Painkillers After Tooth Extraction: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Efficacy of Shyama Tulsi (Ocimum Sanctum Linn) Extract Impregnated with Calcium Sulphate Hemihydrate as an Alternative to Systemic Antibiotics and Painkillers Post- Extraction – 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 |
Anantam Mudgal |
| Designation |
Student |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414355448 |
| Fax |
|
| Email |
anantammudgal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shallu Bansal |
| Designation |
Professor & Head |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Deptartment Of Oral And Maxillofacial Surgery
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
91161155666 |
| Fax |
|
| Email |
drshallu23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shallu Bansal |
| Designation |
Professor & Head |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Deptartment Of Oral And Maxillofacial Surgery
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
91161155666 |
| Fax |
|
| Email |
drshallu23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Geetanjali Dental And Research Institute, Geetanjali university Udaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Geetanjali Dental & Research Institute |
| Address |
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001 |
| Type of Sponsor |
Research institution |
|
|
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 Shallu Bansal |
Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute, Udaipur |
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, 313001
Udaipur
RAJASTHAN |
9116155666
drshallu23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human research ethic committee of Geetanjali university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z764||Other boarder to healthcare facility. Ayurveda Condition: DANTAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | conventional way of extraction | n this group of patients, after extraction we will prescribe routine Antibiotic (amoxiclav 625mg bd )for three days and painkiller (zerodol) bd for three days without placing anything in extraction socket. this is the conventional way of doing the extraction | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: OCIMUM SANCTUM LEAF EXTRACT, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 4(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: In this we are preparing a paste of 4% OCIMUM SANCTUM LEAF EXTRACT with human graded calcium sulfate hemihydrate and it will be placed in socket after socket and patient will be evaluated for need of painkiller or antibiotics |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in between the age of 18 to 60 years who require extraction of tooth.
2. Healthy patients falling under category of ASA I and ASA II.
3. Subjects able and willing to provide well informed written consent and comply with study procedure. |
|
| ExclusionCriteria |
| Details |
1. The subjects taking regular analgesics and antidepressants.
2. Patients having systemic diseases.
3. Patients having acute infections.
4. History of drug abuse.
5. Patients allergic to amoxicillin, NSAIDs and Shayma Tulsi (Ocimum sanctum Linn).
6. Patients having previous history of radiation therapy in the head and neck region.
7. Pregnant and nursing women were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. pain
2. dry socket/ infection |
1. pain- on 1st, 3rd and 7th post operative day
2. dry socket/ infection-on 1st, 3rd and 7th post operative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any other complication if present will be noted |
complications on 1st,3rd & 7th day |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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)
|
29/11/2024 |
| 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="3"
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
|
The extraction of tooth is one of the most common dental procedures carried out
worldwide in dental setups. Owing to the nature and environment of the procedure
many dentists prescribe combination of antibiotics and analgesics postoperatively.
According to Cochrane database antibiotics reduce the risk of infection in patients by
70% and dry socket by 30% , but emergence of the drug resistance is the major concern.
For post-extraction pain NSAIDs are prescribed for 3-5 days. Gastric pain, mucosal
erosions and ulcerations produced by NSAIDs are the major concerns regarding the
dosage and type of NSAIDs .
Emergence of drug resistance and undesirable side effect of certain drugs has triggered
immense interest in the search of new antimicrobials and anti-inflammatory alternatives
of plant origin in the form of local drug delivery mode. The most important advantage
for therapeutic use of medicinal plants in various ailments is their safety besides
being economical, effective and readily available.
Tulsi, also referred to as "the elixir of life," is renowned for its association with longevity.
In Ayurveda and Siddha medicine, various parts of the plant are utilized to prevent and
treat numerous illnesses and common ailments, ranging from the common cold to
headaches, coughs, influenza, earaches, fevers, colic pain, sore throats, bronchitis,
asthma, hepatic diseases, malarial fever, snake bites, scorpion stings, flatulence, migraine
headaches, fatigue, skin diseases, wounds, insomnia, arthritis, digestive disorders, night
blindness, and diarrhea. Tulsi leaves, in particular, are valued for their positive effects on nerves and memory
enhancement. Chewing Tulsi leaves is recognized for its efficacy in treating ulcers and
mouth infections. Additionally, it is believed that adding a few Tulsi leaves to drinking
water or food can purify and eliminate microorganisms. Holy Basil, or Tulsi, is highly
regarded for its ability to boost the immune system, providing protection against a diverse
range of infections caused by viruses, bacteria, fungi, and protozoa. Recent studies even suggest its potential in inhibiting the growth of HIV and carcinogenic cells. In dentistry Ocimum Sanctum Linn (Shayma tulsi) had been widely used as an
antimicrobial, analgesic, anti-pyretic, anti-inflammatory and as anti-gingivitis agent. It
has also shown its anticariogenic properties.The minimal inhibitory concentration
(MIC) of Ocimum Sanctum Linn as antimicrobial agent was found to be 4%, 6%and
10% by Agarwal P et al., Gupta B et al., Gadiyar A et al.The variation may be
due to the fact that the chemical constitutes may vary due to graphic and geographic
factors, difference in the microbiological method used and variation in the solvent used
to prepare the extract. In vivo 4% Ocimum Sanctum Linn had been used as dentifrices,
mouthwashes and gels proving the potential use of this as antimicrobial and an
analgesic in dentistry. Literature pertaining to the use of Shayma Tulsi as
antimicrobial and anti-inflammatory agent post extraction has not been reported earlier
till date.
Human graded calcium sulphate hemihydrate was one of first bone substitutes used in
orthopedics and dentistry because it is readily available, easily sterilized, inexpensive,
completely and rapidly resorbable, and biocompatible. In addition, calcium sulphate
hemihydrate is osteoconductive; it is not osteoinductive in itself, but in the presence of
bone and/or periosteum it almost always becomes osteogenic. In dentistry it had been widely used for periodontal defect repair, sign of augmentation,
extracted socket preservation and adjunct to dental implant placement for more than
two decade. Orellana et al suggested that human graded calcium sulphate
hemihydrate can also act as sustainable drug delivery carrier.
Therefore, the present randomised controlled trial is conceptualised as an initial step
to comprehensively report the antimicrobial and analgesic effect of Shayma Tulsi
(Ocimum Sanctum Linn) with Human Graded Calcium sulphate Hemihydrate as a
carrier in post-extraction cases. The hypothesis behind our study is that there is no
significant difference in efficacy between Shayma Tulsi extract (Ocimum Sanctum
Linn) with Human Graded Calcium Sulphate Hemihydrate and conventional systemic
antibiotics and painkillers post-extraction. |