NCT05568563

Brief Summary

Comparing Pre-cooling with Ethyl Chloride versus Honey in Alleviating Intra-oral injection pain in Adult patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

October 2, 2022

Last Update Submit

October 29, 2022

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

  • To alleviate dental injection pain

    Post administration of oral local anesthetic infiltration pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured

    immediately after completion of administration of oral local anesthetic infiltration within 60 seconds

Study Arms (3)

Ethyl chloride

EXPERIMENTAL
Drug: Ethyl chloride

Honey

EXPERIMENTAL
Other: Honey

Control

NO INTERVENTION

Interventions

Ethyl chlorideDRUG

Ethyl chloride is an agent that is widely used in dental practice as the standard modality for pulp vitality tests .

Ethyl chloride
HoneyOTHER

Honey is a natural dietary product

Honey

Eligibility Criteria

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

You may qualify if:

  • No medical history
  • Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration

You may not qualify if:

  • Patients having any medical conditions considered to affect patient safety or the quality of the study
  • if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hira Danish

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Interventions

Ethyl ChlorideHoney

Intervention Hierarchy (Ancestors)

Hydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 2, 2022

First Posted

October 5, 2022

Study Start

August 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)