Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers

Oral Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633292
• Other study ID #: RCT-04-16
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: August 2018
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

Inclusion Criteria:

• Patients who have just begun orthodontic treatment after bracket cementation.

• Be willing and have signed the informed consent.

• Presence of cemented metal brackets throughout the upper and lower arches.

• Presence of good oral health: dental, periodontal and soft tissue

Exclusion Criteria:

• Allergic or who have suffered adverse reactions to Chlorhexidine or Aloe Vera.

• Pregnant, since they are not claimants of fixed multibrackets appliances.

• Presence of auxiliary extraoral appliances during the treatment that may cause additional injuries.

• Under 11 years old.

Related Conditions & MeSH terms

• Oral Ulcer
• Ulcer

Intervention

Drug:
• Antiseptic clorhexidine gel (Lacer, Barcelona, Spain)
Together with the dispensing container, the dosing and dosage of the gel in research will be attached, with the description of the pharmaceutical form, packaging and labeling of the product. Packages with 8 ml of the gel under investigation, sufficient treatment for 1 month of applications. Posology: After tooth brushing, apply a small amount of gel on the fingertip of a freshly washed finger and spread it over the gum, doing a gentle massage, for 15 ", 2 times a day after proper oral hygiene and it is recommended not to ingest no liquid or food until after half an hour of use.
• Master formula of aloe vera gel 80%
Blindly and in the same container as chlorhexidine, patients will be instructed to apply aloe vera gel on the gums and mucous membranes once the orthodontic appliances have been cemented

Locations

Country	Name	City	State
Spain	Mario Pérez Sayáns	Santiago De Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	University of Alfonso X El Sabio

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Security and tolerability - number of participants with treatment related adverse events as assessed by CTCAE v4.0	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.	30 days
Primary	Prevalence of traumatic oral ulcers	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.	30 days
Secondary	Prevalence of gingival inflammation	One month after cementing and coinciding with the periodic visit of the patient, the presence / absence gingival inflammation through the gingival inflammation index will be evaluated.; 0 = Normal gingiva, absence of inflammation, no change in color, no bleeding.; 1 = slight inflammation, slight change in color, small alteration of the surface, no hemorrhage. 2 = Moderate inflammation, redness, edema and hemorrhage on probing and pressure. 3 = Strong inflammation, intense redness, edema, tendency to hemorrhages, eventually ulceration. It is interpreted as follows: Sum of the degree of each face / No. of faces observed 0.0-1.0 = incipient gingivitis 1.1-2.0 = Moderate gingivitis 2,1-3,0 = Severe gingivitis	30 days
Secondary	Prevalence of gingival bleeding	One month after cementing and coinciding with the periodic visit of the patient, the presence / absence of gingival bleeding through the gingival index or Simplified haemorrhage index (DHI). It is taken on four sides of the tooth, distal, vestibular, mesial and palatal. The average of the four measurements will be the value of that patient. Periodontal probe will be used. 0 = absence of hemorrhage; 1 = presence of haemorrhage.	30 days