Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment

Not Applicable

Completed

• Conditions: Pericoronitis
• Interventions: Other: OxyFlower gel; Other: Chlorhexidine gel; Other: Placebo gel

• Registration Number: NCT03919942
• Lead Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri

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.

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 Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Study Start: 2019-04-19
• Primary Completion: 2019-06-01
• Study Completion: 2019-12-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OxyFlower gel	OxyFlower gel	pericoronitis treatment with oxyflower gel.
Chlorhexidine gel	Chlorhexidine gel	pericoronitis treatment with chlorhexidine gel.
Placebo gel	Placebo gel	pericoronitis treatment with placebo gel.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Quality of life	baseline, 30 days	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).
Change from Baseline Pain	baseline, 1,3,7,15 and 30 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri; 🇧🇷 Diamantina, Minas Gerais, Brazil