Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers

• ClinicalTrials.gov Identifier: NCT03633292
• Recruitment Status: Completed
• First Posted: August 16, 2018
• Last Update Posted: August 16, 2018
• Sponsor: University of Santiago de Compostela
• Collaborator: Alfonso X El Sabio University
• Information provided by (Responsible Party): Mario Pérez Sayáns, University of Santiago de Compostela

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Oral Ulcer	Drug: Antiseptic clorhexidine gel (Lacer, Barcelona, Spain); Drug: Master formula of aloe vera gel 80%	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: September 2017
• Actual Study Completion Date: January 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Clorhexidine; - Clorhexidine Gel (LACER®, Barcelona, Spain) 0.12%, application 2 times / days for 1 month. The gel will be applied two times/day each 12 hours to the gingiva and mucosa.	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.
Experimental: Aloe Vera; - 80% Aloe vera gel, application 2 times / day for 1 month Master formula of 80% aloe vera gel Aloe Vera extract, obtained from the central part of the caudal leaves of plants with more than 8 years of life, eliminating its bark. Formulated with carbopol, hydrophilic crosslinked polymer of acrylic acid and vitamin C. The mixture is presented in containers that serve as a container for preparation and will be dispensed in the canister format with applicator tube.	Drug: 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Prevalence of gingival inflammation [ Time Frame: 30 days ]

   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

2. Prevalence of gingival bleeding [ Time Frame: 30 days ]
   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.

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 11 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Spain

Mario Pérez Sayáns

Santiago De Compostela, A Coruña, Spain, 15785

Sponsors and Collaborators

University of Santiago de Compostela

Alfonso X El Sabio University

More Information

• Responsible Party: Mario Pérez Sayáns, Principal investigator, University of Santiago de Compostela
• ClinicalTrials.gov Identifier: NCT03633292
• Other Study ID Numbers: RCT-04-16
• First Posted: August 16, 2018
• Last Update Posted: August 16, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Oral Ulcer; Ulcer; Pathologic Processes; Mouth Diseases; Stomatognathic Diseases; Anti-Infective Agents, Local; Anti-Infective Agents