Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers

NCT03633292 | Completed Phase 4 DMC

• 1 other identifier: RCT-04-16
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prevalence of gingival inflammation

  30 days

• Prevalence of gingival bleeding

  30 days

Other Outcomes (1)

• Security and tolerability - number of participants with treatment related adverse events as assessed by CTCAE v4.0

  30 days

Study Arms (2)

Clorhexidine

ACTIVE COMPARATOR

\- 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)

Aloe Vera

EXPERIMENTAL

\- 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%

Interventions

Antiseptic clorhexidine gel (Lacer, Barcelona, Spain) 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.

Clorhexidine

Master formula of aloe vera gel 80% 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

Aloe Vera

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Alfonso X El Sabio University: collaborator

Study Sites (1)

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, 15785, Spain

Location

MeSH Terms

Conditions

Oral Ulcer

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: August 16, 2018
• Study Start: January 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

ES (1)