Viewing Study NCT03633292


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Study NCT ID: NCT03633292
Status: COMPLETED
Last Update Posted: 2018-08-16
First Post: 2018-06-25
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers
Sponsor: University of Santiago de Compostela
Organization:

Study Overview

Official Title: Aloe Vera and Chlorhexidine as Preventive Oral Antiseptics Against the Appearance of Traumatic Oral Ulcers in Patients With Fixed Orthodontics: a Randomized Clinical Trial
Status: COMPLETED
Status Verified Date: 2018-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. The use of chemical agents such as CHX, although it has proven to be useful in these patients, but has the disadvantage of having side effects such as staining, even restricting its use during treatment.

The objective of this study was to determine the efficacy of Aloe vera gel at 80% compared to 0.12% Chlorhexidine gel to alleviate the effects derived from any orthodontic treatment, such as gingival inflammation and hyperplasia and friction or ulcerations. of traumatic oral mucosa-derived from treatment in patients after cementation with metal brackets in the two arches. A total of 140 patients between the ages of 10 and 55 who were randomized and assigned in the two study groups treated with Aloe vera gel versus the conventional Chlorhexidine gel with a sample of 70 subjects in each group participated.

The index of gingival inflammation, plaque index, as well as the simplified hemorrhage index, were evaluated.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: