NCT05875350

Brief Summary

The study aims to assess the use of intraligamental local anesthetic injection compared to buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms of pain control and extraction duration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

29 days

First QC Date

May 12, 2023

Last Update Submit

May 26, 2023

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • Pain using visual analogue scale

    visual analogue scale (VAS) was used in which a pain score was recorded for each patient just after local anesthetic adminstration. The VAS score ranges from 0 (no pain) to 10 (extreme unbearable pain)

    immediately after injection

Study Arms (2)

Intraligamental local anesthetic injection

EXPERIMENTAL
Procedure: Intraligamental local anesthetic injection

Buccal infiltration local anesthetic injection

NO INTERVENTION

Interventions

Intraligamental local anesthetic injectionPROCEDURE

The intraligamental technique was administered using ligajet intraligamentary jet injector (Micro Mega Company) containing Articaine hydrochloride 4% with adrenaline 1:200000 (ArtPharma Dent, inc, Egypt)

Intraligamental local anesthetic injection

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy patients (class I category according to American society of anesthesiologists )
  • Age range: 20 - 60 years of age,
  • Either genders who are seeking dental extraction of maxillary molar teeth diagnosed with grade II mobility.

You may not qualify if:

  • Patients with tooth that require trans osseous extraction
  • Badly broken down coronal structure of the tooth to be extracted
  • Patients with significant medical conditions
  • Alcoh intake
  • Patients on drugs that affect the central nervous systems
  • Patients who reported the use of drugs that might interfere with pain sensitivity
  • Pregnant or lactating women
  • Patients who suffer from hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, 2431412, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 25, 2023

Study Start

March 1, 2023

Primary Completion

March 30, 2023

Study Completion

April 15, 2023

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

EG(1)