Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment

Federal University of the Valleys of Jequitinhonha and Mucuri

Status: Completed

Conditions: Pericoronitis

Treatments: Other: Placebo gel; Other: Chlorhexidine gel; Other: OxyFlower gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03919942

16042019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 3 patient groups, including a placebo group

OxyFlower gel

Experimental group

Description:

pericoronitis treatment with oxyflower gel.

Treatment:

Other: OxyFlower gel

Chlorhexidine gel

Experimental group

Description:

pericoronitis treatment with chlorhexidine gel.

Treatment:

Other: Chlorhexidine gel

Placebo gel

Placebo Comparator group

Description:

pericoronitis treatment with placebo gel.

Treatment:

Other: Placebo gel