Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers
Anahtar kelimeler
Öz
Tarih
Son Doğrulandı: | 07/31/2018 |
İlk Gönderilen: | 06/24/2018 |
Tahmini Kayıt Gönderildi: | 08/12/2018 |
İlk Gönderilen: | 08/15/2018 |
Son Güncelleme Gönderildi: | 08/12/2018 |
Son Güncelleme Gönderildi: | 08/15/2018 |
Fiili Çalışma Başlangıç Tarihi: | 12/31/2014 |
Tahmini Birincil Tamamlanma Tarihi: | 08/31/2017 |
Tahmini Çalışma Tamamlanma Tarihi: | 12/31/2017 |
Durum veya hastalık
Müdahale / tedavi
Drug: Clorhexidine
Drug: Aloe Vera
Evre
Kol Grupları
Kol | Müdahale / tedavi |
---|---|
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: Clorhexidine 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: Aloe Vera 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 |
Uygunluk kriterleri
Çalışmaya Uygun Yaşlar | 11 Years İçin 11 Years |
Çalışmaya Uygun Cinsiyetler | All |
Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
Kriterler | 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. |
Sonuç
Birincil Sonuç Ölçütleri
1. Prevalence of traumatic oral ulcers [30 days]
İkincil Sonuç Ölçütleri
1. Prevalence of gingival inflammation [30 days]
2. Prevalence of gingival bleeding [30 days]
Diğer Sonuç Ölçütleri
1. Security and tolerability - number of participants with treatment related adverse events as assessed by CTCAE v4.0 [30 days]