| CTRI Number |
CTRI/2023/01/049312 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A clinical trial to study the effect of palatal root length on the success of maxillary buccal infiltration by open and closed mouth technique. |
|
Scientific Title of Study
|
Comparative evaluation of the influence of palatal root length on the efficacy of maxillary buccal infiltration by open and closed mouth technique- A randomised control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh K M |
| Designation |
Post graduate student, Department of conservative dentistry and endodontics |
| Affiliation |
The oxford dental college, Bangalore-560068. |
| Address |
Dr Yogesh K M
Post graduate student,
Department of conservative dentistry and endodontics,
Bommanahalli, Hosur road, Bangalore-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
6362256266 |
| Fax |
|
| Email |
yogeshkmreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SrirekhaA |
| Designation |
Professor and Head of the Department, Department of conservative dentistry and endodontics |
| Affiliation |
The Oxford Dental College, Bangalore-560068. |
| Address |
Dr Srirekha A
Professor and Head of the department,
Department of conservative dentistry and endodontics,
The Oxford Dental College,
Bommanahalli, Hosur road, Bangalore-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9620958898 |
| Fax |
|
| Email |
drsrirekha.a@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh K M |
| Designation |
Post graduate student, Department of conservative dentistry and endodontics |
| Affiliation |
The oxford dental college, Bangalore-560068. |
| Address |
Dr Yogesh K M
Post graduate student,
Department of conservative dentistry and endodontics,
Bommanahalli, Hosur road, Bangalore-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
6362256266 |
| Fax |
|
| Email |
yogeshkmreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Yogesh K M |
| Address |
#26, 2nd cross road, kaggalipura, huskur post, bangalore- 560099 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Srirekha |
TODC,
Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yogesh K M |
The Oxford Dental College and Hospital |
Department of conservative dentistry and endodontics,
Post graduate clinic,
Room no 3,
10th mile, Bommanahalli, Bangalore-560068
Bangalore
KARNATAKA |
6362256266
yogeshkmreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, The Oxford Dental College, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lidocaine in 1:80000 adrenaline in closed mouth technique. |
In Group 2:-
Maxillary 1st molars with irreversible pulpitis needing root canal treatment, maxillary buccal infiltration will be given in closed mouth technique. |
| Comparator Agent |
2% lidocaine with 1:80000 adrenaline in open mouth technique. |
In group 1:-
Maxillary 1st molars with irreversible pulpitis needing root canal treatment, maxillary buccal infiltration will be given in open mouth technique. |
| Intervention |
Root canal treatment |
Maxillary 1st molars with irreversible pulpitis will be treated with root canal treatment under 2% lidocaine, with 1:80000 adrenaline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18 to 50 years with symptomatic
irreversible pulpitis in maxillary molars.
2)Teeth without gingival recession or existing
periodontal disease.
3)Patients without chronic systemic disease.
4)Patients able to understand pain scales.
|
|
| ExclusionCriteria |
| Details |
1)Teeth with peri-apical pathology, abscess, sinus
and swelling (non- vital teeth)
2)Teeth with resorptions, calcified canals or
aberrant anatomy.
3)Patients with systemic, immune compromised
disorders including pregnant women.
4)Patients with pace makers.
5)Patients with use of analgesics or anti-
inflammatory drugs 12 hours prior to the
procedure.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale(VAS) |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale(VAS) |
2 minutes, 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2023 |
| Date of Study Completion (India) |
24/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double blind clinical trial comparing the efficacy of maxillary buccal infiltration in open and closed mouth techniques and the influence of palatal root length on it. The study will be conducted in The department of conservative dentistry and endodontics, The Oxford Dental College and Hospital, Bangalore. 60 healthy adults with symptomatic irreversible pulpitis will be randomly allocated into 2 groups. In Group 1, Maxillary buccal infiltration will be performed in open mouth technique and in group 2, maxillary buccal infiltration will be performed in closed technique. The outcome of the study will be evaluated using Visual Analogue Scale (VAS) to measure pain during preoperative and during access opening. |