Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment

Pericoronitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919942
• Other study ID #: 16042019
• Status: Completed
• Phase: N/A
• Start date: April 19, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2022
• Source: Federal University of the Valleys of Jequitinhonha and Mucuri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pericoronitis

Intervention

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
• 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 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

Locations

Country	Name	City	State
Brazil	Universidade Federal dos Vales do Jequitinhonha e Mucuri	Diamantina	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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