Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment

Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment: Controlled Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pericoronitis
• Intervention / Treatment: Other: OxyFlower gel; Other: Chlorhexidine gel; Other: Placebo gel

Detailed Description

This study consist of 51 participants diagnosed with pericoronitis who received coadjuvant treatment with gel. The participants were submitted to emergency treatment, with local debridement and irrigation with saline solution followed by topical application of the randomized gel: oxyflower®, chlorhexidine, or placebo gel. In cases of pericoronitis with systemic signs / symptoms, such as fever, malaise and lymphadenopathy, systemic antibiotic therapy was prescribed one hour before debridement, lasting seven days. All participants received oral hygiene guidelines and were instructed to apply the same gel twice daily for one week . After 30 days, it was performed tooth removal for cases in which there is not enough space for dental eruption; or distal wedge surgery when there is space for dental eruption with excessive gingiva in the distal. It was evaluated as outcomes: pain, quality of life, depth of probing, level of bone crest in the distal of second molar, buccal opening and extent of edema / erythema. A comparative analysis was performed between the groups, before and after treatment.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Diamantina, Minas Gerais, Brazil, 39100000
      • Universidade Federal dos Vales do Jequitinhonha e Mucuri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OxyFlower gel; pericoronitis treatment with oxyflower gel.	Other: OxyFlower gel; 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
Experimental: Chlorhexidine gel; pericoronitis treatment with chlorhexidine gel.	Other: Chlorhexidine gel; 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 Comparator: Placebo gel; pericoronitis treatment with placebo gel.	Other: Placebo gel; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline trismus	maximum mouth opening measured as maximum distance between incisal edges of upper and lower central incisors.	baseline, 1,3,7,15 and 30 days
change from edema / erythema	The extent of edema / erythema was assessed by measuring the greater vestibulo-lingual and mesio-distal distance of the lesion, by periodontal probe.	baseline, 1, 3, 7, 15 and 30 days

Collaborators and Investigators

• Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
• Investigators: Principal Investigator: Patricia F Gonçalves, PhD, Federal University of the Valleys of Jequitinhonha and Mucuri

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Phytotherapy; Pericoronitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Pericoronitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 16042019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No