NCT03501225

Brief Summary

The aim of this study was to evaluate the effect of ozonated water on pain, edema and trismus after third molar removal. Patients were submitted to extraction of lower third molar under irrigation with ozonated water or doubly distilled water. Data were collected at baseline, 24 hours, 48 hours, 72 hours and 7 days after intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

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

November 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

March 28, 2018

Last Update Submit

April 16, 2018

Conditions

OzoneThird MolarClinical Trial

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline Pain at 72 hours

    Post-operative pain measured by visual analogic scale (VAS). The VAS comprises a 10cm horizontal line, with no marks. When responding to a VAS, subjects specify their level of pain by indicating a position along a continuous line between two end-points. Higher values represent a worse outcome.

    24hours, 48hours, 72hours

  • Change from Baseline Swelling at 7 days

    post-operative swelling measured from tragus to mouth corner

    baseline, 24hours, 48hours, 72hours, 7 days

  • Change from Baseline trismus at 7 days

    maximum mouth opening measured as maximum distance between incisal edges of upper and lower central incisors.

    baseline, 24hours, 48hours, 72hours, 7 days

Secondary Outcomes (1)

  • Change from Baseline Quality of life at 7 days

    baseline, 7 days

Study Arms (2)

ozone

EXPERIMENTAL

tooth extraction under irrigation with ozonated water

Procedure: ozone

water

EXPERIMENTAL

tooth extraction under irrigation with ozonated water or doubly distilled water

Procedure: water

Interventions

ozonePROCEDURE

After local anesthesia, it was performed sulcular incision with scalpel blade number 15 and removal of soft tissues. Osteotomy was performed at low rotation and odontosecion at high speed, under constant irrigation with ozonated water. Tooth removal, careful curettage, bone regularization and surgical shop cleaning were then performed under abundant irrigation with ozonated water according to randomization. The suture was then performed.

ozone
waterPROCEDURE

After local anesthesia, it was performed sulcular incision with scalpel blade number 15 and removal of soft tissues. Osteotomy was performed at low rotation and odontosecion at high speed, under constant irrigation with redistilled water. Tooth removal, careful curettage, bone regularization and surgical shop cleaning were then performed under abundant irrigation with redistilled water according to randomization. The suture was then performed.

water

Eligibility Criteria

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

You may qualify if:

  • impacted lower third molar
  • class II-B of Pell-Gregory classification
  • No systemic disease

You may not qualify if:

  • local infection
  • previous periocoronaritis
  • smoke
  • allergy to ozone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

Location

Related Publications (1)

  • Gloria JCR, Douglas-de-Oliveira DW, E Silva LDA, Falci SGM, Dos Santos CRR. Influence of ozonized water on pain, oedema, and trismus during impacted third molar surgery: a randomized, triple blind clinical trial. BMC Oral Health. 2020 Feb 5;20(1):41. doi: 10.1186/s12903-020-1029-5.

    PMID: 32024498DERIVED

MeSH Terms

Interventions

OzoneWater

Intervention Hierarchy (Ancestors)

OxygenGasesInorganic ChemicalsHydroxidesAlkaliesAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • José Cristiano Ramos Glória

    Federal University of the Valleys of Jequitinhonha and Mucuri

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 18, 2018

Study Start

November 8, 2017

Primary Completion

March 9, 2018

Study Completion

March 23, 2018

Last Updated

April 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)