| CTRI Number |
CTRI/2025/04/084588 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Using Chamomile to Relieve Pain and Speed Up Healing After a Tooth Removal |
|
Scientific Title of Study
|
Efficacy of Chamomile in Pain Reduction and Wound Healing Following Tooth Extraction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NANDAM JAHNAVI |
| Designation |
POSTGRADUATE |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Room No-3, Sibar Institute of Dental Sciences, Takkellapadu, Guntur.
Department of Oral and Maxillofacial
Surgery, Room No- 3, Sibar Institute of Dental Sciences, Takkellapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9398038623 |
| Fax |
|
| Email |
nandamjahnavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S ANAND VIJAY |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Room No-3, Sibar Institute of Dental Sciences, Takkellapadu, Guntur.
Department of Oral and Maxillofacial Surgery, Room No-3, Sibar Institute of Dental Sciences, Takkellapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8125555613 |
| Fax |
|
| Email |
dranandvijaysurgery@sids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
NANDAM JAHNAVI |
| Designation |
POSTGRADUATE |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Room No-3, Sibar Institute of Dental Sciences, Takkellapadu, Guntur.
Department of Oral and Maxillofacial Surgery,Room No-3,Sibar Institute of Dental Sciences,Takkellapadu,Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9398038623 |
| Fax |
|
| Email |
nandamjahnavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Room No -3, Sibar Institute of Dental Sciences, Takkellapadu, Guntur,
Andhra Pradesh - 522509
India |
|
|
Primary Sponsor
|
| Name |
NANDAM JAHNAVI |
| Address |
Department of Oral and Maxillofacial Surgery, Room No-3,Sibar Institute of Dental Sciences,Takkellapadu, Guntur,
Andhra Pradesh 522509
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Nanadam Jahnavi |
Sibar Institute of Dental Sciences |
Department of Oral and Maxillofacial Surgery, Room No-3, Takkellapadu, Guntur, Andhra Pradesh - 522509
India
Guntur
ANDHRA PRADESH |
9398038623
nandamjahnavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SIBAR INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHOMOMILE GEL |
2ml of chamomile gel is placed in extraction socket immediately after extraction only one time and sutured
|
| Comparator Agent |
PLACEBO GEL |
2ml of placebo gel placed in extraction socket immediately after extraction only one time and sutured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of anesthesiology class I and II in age group 18- 45 years of age.
2 Patients indicated for closed method extraction of teeth bilaterally diagnosed with chronic irreversible pulpitis.
3 Patients who are willing to give consent |
|
| ExclusionCriteria |
| Details |
1 Patients with active space infection pathology
2 Patients who are on medication for any other systemic issues
3 pregnancy lactation using oral contraceptives
4 patient who are not willing for study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is to assess the efficacy of chamomile gel in improving both pain management and the healing process,number of analgesics taken following bilateral tooth extractions |
Pain was assesed on 1st 2nd 3rd days postoperatively
Wound healing assesed on 7th day
Number of analgesics were recorded postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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="1"
Months="8"
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
|
Extraction of teeth is a common oral surgical procedure The severity of pain following these extractions is influenced by various factors like technique of extraction difficulty patient response Efforts have been made to reduce postoperative symptoms through modifications in surgical techniques medications and complementary treatments Complementary and alternative medicine methods such as herbal medicine in particular is widely used due to its availability low cost and minimal adverse effects Chamomile has long been used in traditional medicine for its soothing anti inflammatory and analgesic properties Given its natural composition and minimal side effects chamomile has gained attention as a complementary treatment to enhance healing of wounds offering a safer and more accessible alternative to conventional pharmaceutical interventions Traditional analgesics often come with side effects and varying effectiveness leading to a search for alternative safer natural remedies Studying the efficacy of chamomile could offer a promising option for enhancing pain relief and promoting tissue healing ultimately improving patient care and recovery experiences in dental practices Patients reporting to the department of oral and maxillofacial surgery during the study period for closed method extraction of teeth bilaterally with chronic irreversible pulpitis are included based on inclusion criteria All the participants will be informed about the study and a written informed consent is obtained from all of them Extraction procedure is carried out on one side Either chamomile gel or placebo gel is placed in the extraction socket and sutured After one week extraction is carried out on the other side Chamomile gel or placebo gel which is not used in the previous extraction is placed in the extraction socket and sutured Pain was assesed on 1st 2nd 3rd days postoperatively Wound healing assesed on 7th day.Number of analgesics were recorded postoperatively All the observations will be recorded tabulated and analysed statistically Results and interpretation of data will be done |