Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers
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ClinicalTrials.gov Identifier: NCT03633292 |
Recruitment Status :
Completed
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | June 25, 2018 | ||||
First Posted Date ICMJE | August 16, 2018 | ||||
Last Update Posted Date | August 16, 2018 | ||||
Actual Study Start Date ICMJE | January 2015 | ||||
Actual Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Prevalence of traumatic oral ulcers [ Time Frame: 30 days ] The patient will attend his scheduled appointment for bracket cementation. Before cementing, we will complete the clinical history (frequency of brushing, smoker or non-smoker, age, sex) aided by intraoral photographs, always collected in the same order according to protocol and by the same researcher. After the cementation, the patient will be included in the study in a random way in the corresponding group. One month after cementing and coinciding with the periodic visit of the patient, the presence / absence of friction or traumatic ulcers will be evaluated.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
Security and tolerability - number of participants with treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: 30 days ] The study subject is obliged to communicate, by telephone or personally, any type of symptom: redness (erythema), thickening (edema) and peeling (ulcer) occurred after application of the products under study, and will must immediately interrupt the use of it, registering the adverse effects and number of participants with treatment related adverse events as assessed by CTCAE v4.0 and using as a rescue product for the treatment of contact mucositis and antiallergic drugs.
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers | ||||
Official Title ICMJE | Aloe Vera and Chlorhexidine as Preventive Oral Antiseptics Against the Appearance of Traumatic Oral Ulcers in Patients With Fixed Orthodontics: a Randomized Clinical Trial | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Oral Ulcer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
140 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | January 2018 | ||||
Actual Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 11 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03633292 | ||||
Other Study ID Numbers ICMJE | RCT-04-16 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Mario Pérez Sayáns, University of Santiago de Compostela | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Santiago de Compostela | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Alfonso X El Sabio University | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University of Santiago de Compostela | ||||
Verification Date | August 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |