| CTRI Number |
CTRI/2024/12/078636 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison of Post-Surgery Effects Using Continuous Pump Irrigation vs. Manual Irrigation in Wisdom Tooth Extraction |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF POST OPERATIVE SEQUELAE BY
USING PNEUMATIC PUMP CONTINUOUS IRRIGATION WITH MANUAL
IRRIGATION FOR SURGICAL EXTRACTION OF MANDIBULAR THIRD
MOLAR |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr sharda soni |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Raipur |
| Address |
Department of oral and maxillofacial surgery, Government dental college Raipur
Department of oral and maxillofacial surgery, Government dental college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
08770707418 |
| Fax |
|
| Email |
shardasoni151996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biju Pappachan |
| Designation |
PROFESSOR |
| Affiliation |
Government Dental College and Hospital Raipur |
| Address |
Department of oral and maxillofacial Surgery, Government Dental college ,Raipur
Department of oral and maxillofacial Surgery, Government Dental college ,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
08770707418 |
| Fax |
|
| Email |
bijupappachan2121@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sharda soni |
| Designation |
Post Graduate |
| Affiliation |
Government Dental College and Hospital Raipur |
| Address |
Department of oral and maxillofacial Surgery, Government Dental college ,Raipur
Department of oral and maxillofacial Surgery, Government Dental college ,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
08770707418 |
| Fax |
|
| Email |
shardasoni151996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Raipur |
|
|
Primary Sponsor
|
| Name |
Dr sharda soni |
| Address |
Government dental college and Hospital, Raipur, 492001 |
| 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 sharda soni |
Government dental college Raipur |
room no-10, Department of oral and maxillofacial surgery
Raipur
CHHATTISGARH |
8770707418
shardasoni151996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF GOVERNMENT DENTAL RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients coming under American Society of Anesthesiologists (ASA) I.
|
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
continuous irrigation |
A split-mouth randomized controlled clinical trial will be conducted among 27 patients to evaluate the effect of pneumatic pump continuous irrigation using physiodispenser on pain, edema, and trismus after surgical extraction of mandibular third molars. |
| Comparator Agent |
manual irrigation |
A split-mouth randomized controlled clinical trial will be conducted among 27 patients to evaluate the effect of manual irrigation on pain, edema, and trismus after surgical extraction of mandibular third molars. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who requires prophylactic surgical removal of bilaterally impacted mandibular third molar (Mesioangular class II, position A).
2. Patient aged below 30 years.
3. Patients coming under American Society of Anesthesiologists (ASA) I.
4. No contra-indication to the drugs or anesthetic which will be used in the surgical protocol.
5. Patient willing to participate and has given written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Acute Pericoronitis.
2. Pregnant and lactating women
3. Patient with chronic use of medication such as antihistaminic, nonsteroidal anti-inflammatory drugs which would complicate evaluation of their postoperative response.
4. Patient coming under category of American society of anesthesiologist II III and IV.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study result will help us to know the influence of pneumatic pump continuous irrigation with manual irrigation in the post operative inflammatory sequelae after surgical extraction of third molars. |
o day, 1st day, 3rd day, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The results could contribute to the development of new irrigation methods in oral surgery which will enhance clinical practice and can be used for further research. |
0,1,3,7 day |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2025 |
| Date of Study Completion (India) |
01/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 present study aims to evaluate and compare the influence of pneumatic pump continuous irrigation with manual irrigation on post operative inflammatory sequelae following surgical extraction of similarly placed mandibular third molars bilaterally. A split-mouth randomized controlled clinical trial will be conducted among 27 patients to evaluate the effect of pneumatic pump continuous irrigation versus manual irrigation on pain, edema, and trismus after surgical extraction of mandibular third molars. The study will include patients needing surgical extraction of impacted third molars who willingly participate and agree to the postoperative follow-up. Each patient will serve as both the test group (physiodispenser with pneumatic pump continuous irrigation) and the control group (conventional rotary instrument with manual irrigation). Randomization for irrigation method and which side of the tooth would be extracted from will be determined via a lottery method. | |