| CTRI Number |
CTRI/2018/08/015227 [Registered on: 07/08/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Assessment of pain after injection inside the tooth with different size needles during root canal treatment |
|
Scientific Title of Study
|
Assessment of pain during intrapulpal anesthesia administered using different needle gauges– A double blinded randomized clinical 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 S Nandini |
| Designation |
Reader (MDS) |
| Affiliation |
Meenakshi Ammal Dental College |
| Address |
Dept of Conservative dentistry and Endodontics
Meenakshi Ammal Dental College
Alapakkam high road
Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9884292850 |
| Fax |
|
| Email |
nandini_80@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Nandini |
| Designation |
Reader (MDS) |
| Affiliation |
Meenakshi Ammal Dental College |
| Address |
Dept of Conservative dentistry and Endodontics
Meenakshi Ammal Dental College
Alapakkam high road
Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9884292850 |
| Fax |
|
| Email |
nandini_80@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Nandini |
| Designation |
Reader (MDS) |
| Affiliation |
Meenakshi Ammal Dental College |
| Address |
Dept of Conservative dentistry and Endodontics
Meenakshi Ammal Dental College
Alapakkam high road
Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9884292850 |
| Fax |
|
| Email |
nandini_80@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal Dental College |
|
|
Primary Sponsor
|
| Name |
Dr N Velmurugan |
| Address |
Dept of Conservative dentistry and Endodontics
Meenakshi Ammal Dental College
Maduravoyal
Chennai 95 |
| 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 |
| Nandini |
Meenakshi Ammal Dental College |
Room no 9, Department of Conservative dentistry and Endodontics
Chennai
TAMIL NADU |
9884292850
nandini_80@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients requiring root canal treatment in lower molars with symptomatic irreversible pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1- 27 gauge without topical
Group 2- 27 gauge with topical |
Group 1- Intrapulpal anesthesia using 27-gauge needle with 2% lignocaine with adrenaline 1:80000 without topical anesthesia
Group 2- Intrapulpal anesthesia using 27-gauge needle with 2% lignocaine with adrenaline 1:80000 without topical anesthesia
|
| Intervention |
Group 3: (31 G)
Group 4: (31 G with topical anesthesia) |
Group 3: (31 G) - Intrapulpal anesthesia using 31-gauge needle with 2% lignocaine with adrenaline 1:80000 without topical anesthesia.
Group 4: (31 G with topical anesthesia)
Intrapulpal anesthesia using 31-gauge needle with 2% lignocaine with adrenaline 1:80000 with topical anesthesia.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with symptomatic irreversible pulpitis planned for endodontic treatment in mandibular molars. (VAS score > 6).
2. Failed Inferior alveolar nerve block.
|
|
| ExclusionCriteria |
| Details |
1. Immature young permanent teeth.
2. Teeth that do not respond to traditional vitality tests.
3. Cases of necrotic pulp, periapical lesion, dentoalveolar abscess.
4. Medically compromised patients.
5. Patients under long term medications that influence pain threshold.
6. Retreatment cases
7. Patients with a history of intake of analgesics, steroids and / or antibiotics in the recent past 48 hours.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The level of pain will be assessed using Heft Parker’s Visual analogue scale |
During intrapulpal injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The level of pain will be assessed using Heft Parker’s Visual analogue scale |
During pulp extirpation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
18/01/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
5. Birchfield J, Rosenburg PA. Role of anaesthetic solution in intrapulpal anaesthesia. J Endod.1975; 1:26–27.
6. Malamed SF. Pathways of the pulp. 7th edn. St.Louis: Mosby; 1998. The management of pain and anxiety.In: Cohen S Bums RC, Eds; pp. 665–666.
7. Sooraparaju, Sujatha Gopal et al. “Anaesthetic Efficacy of Topical Benzocaine Gel Combined with Hyaluronidase for Supplemental Intrapulpal Injection in Teeth with Irreversible Pulpitis- A Double Blinded Clinical Trial.†Journal of Clinical and Diagnostic Research : JCDR 9.8 (2015): ZC95–ZC97. PMC. Web. 3 Jan. 2018.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The intrapulpal injection technique is commonly preferred in situations where patients encounter pain or discomfort during pulp extirpation. The main drawback with this technique is that the intrapulpal injection by itself can be highly painful . Various techniques have been tried to reduce the pain during intrapulpal anesthesia with the use of topical anesthesia prior to injection . However, the effect of needle gauge in reducing pain during intrapulpal injection remains unclear.
Null Hypothesis – states that the needle gauge does not influence the pain on injection and anesthetic efficacy of intrapulpal anesthesia. AIM- To evaluate pain on injection and anesthetic efficacy of intrapulpal anesthesia administered using different needle gauges (27 or 31gauge) with or without topical anesthesia |