Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pericoronitis

Intervention / Treatment
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* Other: OxyFlower gel
* Other: Chlorhexidine gel
* Other: Placebo gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OxyFlower gel<br>pericoronitis treatment with oxyflower gel. | Other: OxyFlower gel<br>* 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<br>|
| Experimental: Chlorhexidine gel<br>pericoronitis treatment with chlorhexidine gel. | Other: Chlorhexidine gel<br>* 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.<br>|
| Placebo Comparator: Placebo gel<br>pericoronitis treatment with placebo gel. | Other: Placebo gel<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Pericoronitis, Phytotherapy