NCT03919942

Brief Summary

The objective of this study is to evaluate the clinical effect and the impact on the quality of life of the coadjuvant treatment with Oxyflower® gel in cases of pericoronitis in lower third molar, compared to chlorhexidine gel and placebo gel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

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

First Submitted

Initial submission to the registry

April 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 19, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

April 16, 2019

Last Update Submit

November 8, 2022

Conditions

Pericoronitis

Keywords

Quality of lifePericoronitisPhytotherapy

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Quality of life

    Oral health related quality of life measured by questions related to the quality of life. This questionnaire comprises 14 items within 7 subscales (functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, deficit).

    baseline, 30 days

  • Change from Baseline Pain

    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.

    baseline, 1,3,7,15 and 30 days

Secondary Outcomes (2)

  • Change from Baseline trismus

    baseline, 1,3,7,15 and 30 days

  • change from edema / erythema

    baseline, 1, 3, 7, 15 and 30 days

Study Arms (3)

OxyFlower gel

EXPERIMENTAL

pericoronitis treatment with oxyflower gel.

Other: OxyFlower gel

Chlorhexidine gel

EXPERIMENTAL

pericoronitis treatment with chlorhexidine gel.

Other: Chlorhexidine gel

Placebo gel

PLACEBO COMPARATOR

pericoronitis treatment with placebo gel.

Other: Placebo gel

Interventions

OxyFlower gelOTHER

the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal

OxyFlower gel
Chlorhexidine gelOTHER

the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal.

Chlorhexidine gel
Placebo gelOTHER

the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal

Placebo gel

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • signs / symptoms of pericoronitis with
  • spontaneous pain
  • ASA I or II
  • Consent to participate

You may not qualify if:

  • Periodontal status level IV
  • Smokers
  • antibiotic therapy in the last 2 months

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

MeSH Terms

Conditions

Pericoronitis

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Patricia F Gonçalves, PhD

    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, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 18, 2019

Study Start

April 19, 2019

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)