Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers

University of Santiago de Compostela

Status and phase: Completed; Phase 4

Conditions: Oral Ulcer

Treatments: Drug: Master formula of aloe vera gel 80%; Drug: Antiseptic clorhexidine gel (Lacer, Barcelona, Spain)

Study type: Interventional

Funder types: Other

Identifiers

NCT03633292

RCT-04-16

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 11+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Clorhexidine

Active Comparator group

Description:

- 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.

Treatment:

Drug: Antiseptic clorhexidine gel (Lacer, Barcelona, Spain)

Aloe Vera

Experimental group

Description:

- 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.

Treatment:

Drug: Master formula of aloe vera gel 80%