| CTRI Number |
CTRI/2022/08/044724 [Registered on: 17/08/2022] Trial Registered Prospectively |
| Last Modified On: |
19/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Evaluation of the adequacy of anesthesia achieved by 4% Articaine buccal infiltration during extraction of lower premolars for orthodontic purpose |
|
Scientific Title of Study
|
Evaluation of efficacy of buccal infiltration anesthesia with 4% articaine for orthodontic extraction of mandibular premolars: a placebo controlled split mouth study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramandeep Singh Brar |
| Designation |
Professor |
| Affiliation |
Dasmesh Institute Of Research and Dental Sciences, Faridkot |
| Address |
Department of Oral and Maxillofacial Surgery(No.3), Dasmesh Institute Of Research and Dental Sciences, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8146669520 |
| Fax |
|
| Email |
dr.ramanbrar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramandeep Singh Brar |
| Designation |
Professor |
| Affiliation |
Dasmesh Institute Of Research and Dental Sciences, FaridkotT |
| Address |
Department of Oral and Maxillofacial Surgery(No.3), Dasmesh Institute Of Research and Dental Sciences, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8146669520 |
| Fax |
|
| Email |
dr.ramanbrar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Simrat Kaur |
| Designation |
Post graduate student |
| Affiliation |
Dasmesh Institute Of Research and Dental Sciences, Faridkot |
| Address |
Department of Oral and Maxillofacial Surgery (No.3), Dasmesh Institute Of Research and Dental Sciences, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8599922215 |
| Fax |
|
| Email |
ksimrat90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dasmesh Institute Of Research and Dental Sciences, Faridkot |
|
|
Primary Sponsor
|
| Name |
Dasmesh Institute Of Research and Dental Sciences Faridkot |
| Address |
Dasmesh Institute Of Research and Dental Sciences Talwandi road Faridkot |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ramandeep Singh Brar |
Dasmesh Institute Of Research and Dental Sciences, Faridkot |
Oral and maxillofacial surgery, Department No.3
Faridkot
PUNJAB |
8146669520
dr.ramanbrar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
M26.4
MALOCCLUSION: Requiring extraction of mandibular premolars |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP1: Articaine(septanest) infiltration for orthodontic extraction of premolars |
Extraction of mandibular premolars will be done using buccal and lingual infiltration of 4% Articaine with 1:100000 epineprine |
| Intervention |
GROUP2: Articaine(septanest) and 0.9% normal saline infiltration for orthodontic extraction of premolars |
Extraction of mandibular premolars will be done using buccal infiltration of 4% Articaine with 1:100000 epineprine and lingual infiltration of 0.9% normal saline |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group of 15 to 25
2.Patients who want extraction of both left and right mandibular premolars
3.Patients belonging to ASA class I and II
4.Patients who grant consent to be a part of the study
|
|
| ExclusionCriteria |
| Details |
1. History of allergy to local anesthetic agents
2. History of uncontrolled diabetes mellitus, hypertension, or renal diseases
3. Patients on central nervous system depressants including alcohol or any analgesic medication within the last 48 hours
4. Pregnant and lactating females
5. Patients having abscess or any other lesion at the injection site
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the amount of pain perceived on Visual Analogue Scale of 10cm length (VAS-10).
2.To assess the profoundness of lingual anesthesia: It will be determined by degree of sensibility of lingual mucosa to pin prick test on a 5-score verbal scale
|
5 minutes after giving anesthetic, during extraction of tooth. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for extraction and patient satisfaction |
just after completion of procedure |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/08/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.ramanbrar@yahoo.com].
- For how long will this data be available start date provided 01-08-2024 and end date provided 01-08-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
1. Patients who fulfil inclusion criteria will be selected 2. The study design will be discussed with every selected subject 3. Informed written consent will be obtained 4. Patients will be seated on the dental chair and explained about VAS and verbal satisfaction score & pinprick score before starting the procedure 5. All the extractions will be done by single surgeon 6. Each patient will be asked to rinse the oral cavity with chlorhexidine mouthwash(0.2%) for 30 seconds 7. Under aseptic conditions, peri-oral area will be scrubbed using 5% povidine iodine solution and patient will be draped with sterile sheets 8. Injection site will be cleaned with sterile gauze 9. A 27gauge needle attached to dental syringe and cartridge will be used for buccal infiltration. To deliver lingual infiltration a sterile disposable insulin syringe will be used 10. Patients under the study: Group I- will receive buccal infiltration of 1.8 ml 4% articaine with 1:100000 epinephrine plus lingual infiltration of 0.4 ml 4% articaine and Group II- will receive buccal infiltration of 1.8 ml 4% articaine with 1:100000 epinephrine plus lingual infiltration of 0.4 ml normal saline (placebo). 11. Patient will be informed to report the numbness of lip as soon as they feel 12. After 5 minutes the buccal and lingual gingiva will be examined using a pinprick test (with probe). Lingual anesthesia will be assessed on 5-score verbal scale. Whenever pain experienced by the patient will be reported as "obviate" (score 2) or more, it will be considered as a failure of the buccal infiltration and additional infiltration of articaine will be given lingually and we will wait for additional 5 minutes before continuing the procedure 13. Intra-alveolar (forceps) technique will be used for the extraction after routine tooth luxation by dental elevator 14. Care will be taken to ensure minimal trauma to the surrounding tissue 15. Pain will be assessed on VAS during extraction 16. Patients will be asked to rate the degree of their satisfaction on the verbal scale after extraction 17. Time taken to complete the procedure will be recorded 18. Post operative instructions will be given and analgesic will be prescribed The values will be tabulated and results will be derived |