| CTRI Number |
CTRI/2025/07/091857 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
"Study to Evaluate Pain Relief by Using Bupivacaine in Tooth Socket After Surgical Removal of Lower Wisdom Tooth" |
|
Scientific Title of Study
|
Evaluation of Efficacy of Intrasocket Local Application of Bupivacaine as Add on Pain Control Therapy in Patients Undergoing Surgical Extraction of Mandibular Third Molar: A Randomized Control Clinical 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 |
Dr Shagun Soni |
| Designation |
Post Graduate Student |
| Affiliation |
Nair Hospital Dental College |
| Address |
107, Department Of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai Central, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7972405039 |
| Fax |
|
| Email |
shagunsoni2.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Gandhewar |
| Designation |
Assistant Professor |
| Affiliation |
Nair Hospital Dental College |
| Address |
107, Department Of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai Central, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819323729 |
| Fax |
|
| Email |
tgandhewar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trupti Gandhewar |
| Designation |
Assistant Professor |
| Affiliation |
Nair Hospital Dental College |
| Address |
107,Department Of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai Central, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819323729 |
| Fax |
|
| Email |
tgandhewar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Oral and Maxillofacial Surgery Department, Nair Hospital dental College, Mumbai, Maharashtra, India - 400008 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Shagun Soni |
Nair Hospital Dental college |
107, Department Of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai Central, Mumbai 400008
Mumbai
MAHARASHTRA |
7972405039
shagunsoni2.ss@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 |
| Healthy Human Volunteers |
Clinically and Physically healthy patients needing surgical extraction of mandibular 3rd molar |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
After surgical extraction of mandibular 3rd molar a gel foam soaked in 2ml of 0.5% bupivacaine will be placed in socket once and sutures will be given. Pain will be checked at 4, 6 and 8 hours |
| Comparator Agent |
Normal Saline |
After surgical extraction of mandibular 3rd molar a gel foam soaked in 2ml saline will be placed in socket once and sutures will be given. Pain will be checked at 4, 6, and 8 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Position B (according to Winters classification based on
depth for impacted third molar)
2. Healthy patients of age 18 years and above of either
gender requiring surgical extraction of impacted mandibular
third molars.
3. Patients willing to participate in the study.
4. Anaesthesiologists physical classification level 1 (ASA-1) |
|
| ExclusionCriteria |
| Details |
1. Patients with possible allergies or hypersensitivity to study
drug and local anaesthesia and to drugs such as antibiotics
and anti-inflammatory drugs.
2. Medically compromised patients such as cardiovascular
disease, diabetes mellitus, hepatic disease, blood disorder, GI
bleeding or ulceration.
3. Mentally challenged patients, pregnant women and
Lactating mothers.
4. Patients on corticosteroid therapy.
5. Patients with reduced mouth opening due to conditions
such as oral submucous fibrosis and hypoplastic mandible. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the duration of pain relief obtained after
locally administered Bupivacaine. |
Patients will be evaluated
post administration of drug and to score the overall pain at 4hr, 6hr and 8hr using the VAS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To quantify the period of administration of an additional
analgesic in the post operative period after locally
administered Bupivacaine. |
Pain will be assessed at 4, 6 & 8 hours. Once the pain starts patients will be asked to take the analgesic
drug after onset of pain & note the timing of medication. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
08/08/2025 |
| 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="1"
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
|
The management of post-operative dental pain is imperative to eliminate patient suffering, improve quality of life, and reduce healthcare costs. Post-surgical dental pain is typically treated with orally administered analgesics that block inflammatory mediators (e.g., non-steroidal anti-inflammatory drugs, corticosteroids) or block central mechanisms of pain perception (e.g., opioids). Although extremely beneficial for managing pain, these orally delivered drugs require continuous self-medication, and hold potential for adverse systemic effects, including sleep disruption, nausea, neurological dysfunction, circulatory/respiratory depression, and addiction. Alternatively, anaesthetic drugs that block peripheral nerve impulses, such as bupivacaine, are delivered locally to the surgical site, thereby lessening the quantity of necessary postoperative analgesics and mitigating the deleterious effects of oral medications. For instance, a single injection of Bupivacaine results in a maximum plasma drug concentration within 30–45minutes, with complete elimination after 6 hours. Local drug delivery of local anaesthetics may improve dental pain management by prolonging drug effectiveness, and reducing toxicity by slowing drug uptake into systemic circulation. Current approaches to achieve sustained duration of anaesthetic involve co-formulation of drug with a biocompatible polymeric carrier, which controls drug release kinetics. Bupivacaine is an Amide type of Anaesthetic agent and is known for postoperative pain control. According to Stanley F. Malamed The patients requirement for postoperative opiod analgesics is considerably lessened when bupivacaine is administered for pain control. For short surgical procedure (<30 min) Bupivacaine may be administered at the start of procedure following administration of the local anaesthetic chosen for periprocedural pain management. However, for postoperative pain control after lengthy surgical procedures, it is reasonable to administer Bupivacaine at the conclusion of the procedure, just before the patients leave the dental operating chair. 16 Many studies have used Bupivacaine- Soaked gelatin sponges in major surgeries to reduce post operative analgesia. The development and use of local anaesthetics for intraoperative anaesthesia and postoperative analgesia is considered to be one of the most important advances in dentistry in the last century. Talimkhani et al. used the intra-socket administration of bupivacaine with a prepared catheter fixated to a mandibular second molar, with its cannula inserted into the socket of the extracted third molar so that the patients could directly administer drugs (bupivacaine or saline as a placebo) into the tooth socket. bupivacaine significantly relieved postoperative pain after the surgical extraction of Impacted Mandibular Third Molar Surgery. Several researchers have credited bupivacaine with the ability to provide prolonged postoperative analgesia and to minimize analgesic requirements in the early postoperative hours, when pain is at its highest intensity. Its long duration of action and superior ability to decrease pain and discomfort have been reported in comparison with articaine and lidocaine. Therefore, bupivacaine is a common choice for pain control following impacted mandibular third molar extraction. The delivery of a local anaesthetic agent to the postextraction socket has been described to alleviate postoperative pain. However, the use of local delivery therapeutics requires some mechanism to maintain the agent within the oral environment for an adequate period of time to prolong drug effectiveness and reduce its toxicity by slowing drug uptake into the systemic circulation. Few studies have investigated the effect of the local application of bupivacaine in post-extraction sockets 17 following the surgical removal of Impacted mandibular third molar surgery. Therefore, the aim of this study was to assess the effect of the local application of bupivacaine on reducing early postoperative pain following IMTM surgery Therefore, to induce the effects of bupivacaine locally into the extraction socket, Absorbable Gelatin sponge can be used as a vehicle. Absorbable Gelatin sponge is water insoluble, porous sponge prepared from dried and sterilized porcine gelatin. It has very little tissue reaction, liquefies in the socket within a week and fully absorbed within 4 to 6 weeks. It has been used as vehicle to carry medicaments applied to the bleeding site, such as topical thrombin for hemostasis. Locally delivered drug will bypass the undesired toxic systemic adverse effects. The aim of this study is to assess the Effect of Intra-Socket delivery of Bupivacaine in Post Extraction initial Dental Pain. |