NCT03261869

Brief Summary

this study evaluates the effect of cold application after impacted third molar extractions. Patients have bilateral impacted third molar tooth included in this study. Patients do not applied cold after extraction of third molar on one side and applied cold cold after extraction of third molar on the other side.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

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

January 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

August 23, 2017

Last Update Submit

August 23, 2017

Conditions

Impacted Third Molar Tooth

Keywords

Ice pack therapy, third molar surgery, swelling, pain, trismus

Outcome Measures

Primary Outcomes (3)

  • Post operative Visual Analogue Scale Scores

    pre-operative-postoperative 7th day

  • Post operative facial swelling

    pre-operative-postoperative 7th day

  • Post-operative mouth opening

    pre-operative-postoperative 7th day

Secondary Outcomes (1)

  • Complications after impacted third molar removal

    pre-operative-postoperative 7th day

Study Arms (2)

Cold application

EXPERIMENTAL

Cold applied after extraction of third molar tooth.

Other: Cold application

No Cold application

NO INTERVENTION

Cold application is not advised after extraction of third molar tooth

Interventions

Cold applicationOTHER
Cold application

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Bilateral bony mandibular third molar impactions
  • Has no systemic disease

You may not qualify if:

  • Different Pell-Gregory classification of impacted teeth
  • Previous or current gastric ulcer
  • Allergies or hypersensitivities to any common medications
  • pregnant or breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainTrismus

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpasmNeuromuscular ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant at deparment of oral and maxillofacial surgery

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share