Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers

NCT ID: NCT03633292

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Oral Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Antiseptic clorhexidine gel (Lacer, Barcelona, Spain)

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Master formula of aloe vera gel 80%

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alfonso X El Sabio University

OTHER

Sponsor Role: collaborator

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Mario Pérez Sayáns

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, Spain

Countries

Spain

Other Identifiers

RCT-04-16

Identifier Type: -

Identifier Source: org_study_id