NCT06186921

Brief Summary

This study will aim to evaluate postoperative pain after intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine and 2% lidocaine given to the patients with symptomatic irreversible pulpitis after completion of the first appointment. Objectives: 1. To evaluate postoperative pain in patients receiving intraligamentary injections of either dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine or 2% lidocaine. 2. To compare the postoperative pain in different groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2024

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 17, 2023

Last Update Submit

December 17, 2023

Conditions

Pulpitis

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours and 72 hours after treatment.

    2 hours, 6 hours, 24 hours and 72 hours after treatment

Study Arms (4)

Intraligamentary injection of dexamethasone

EXPERIMENTAL

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Drug: Dexamethasone

Intraligamentary injection of diclofenac sodium

EXPERIMENTAL

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Drug: Dexamethasone

Intraligamentary injection of 0.5% bupivacaine

EXPERIMENTAL

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Drug: Dexamethasone

Intraligamentary injection of 2% lidocaine

ACTIVE COMPARATOR

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.

Also known as: diclofenac sodium, bupivacaine
Intraligamentary injection of 0.5% bupivacaineIntraligamentary injection of 2% lidocaineIntraligamentary injection of dexamethasoneIntraligamentary injection of diclofenac sodium

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Symptomatic carious exposed mandibular first or second molars.
  • Positive and prolonged response to thermal sensitivity tests and electric pulp tests.
  • Vital coronal pulp on access cavity preparation.
  • American Society of Anesthesiologists class I or II medical history.
  • Ability to understand the use of pain scales.

You may not qualify if:

  • Active pain in more than 1 tooth
  • Teeth with fused roots.
  • Radiographic evidence of an extra root.
  • Large restorations with overhanging margins.
  • Full crowns or deep periodontal pockets.
  • Known allergy or contraindications to any content of the local anesthetic solution or NSAIDs
  • History of known or suspected drug abuse.
  • Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, NSAIDs.
  • Pregnant or breastfeeding patients.
  • Patients with asthma, gastric ulcers, and bleeding disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, 110025, India

RECRUITING

MeSH Terms

Conditions

Pulpitis

Interventions

DexamethasoneDiclofenacBupivacaine

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 2, 2024

Study Start

December 2, 2023

Primary Completion

March 3, 2024

Study Completion

March 3, 2024

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Locations

IN(1)