Effect of Aloe Vera Mouthwashes on the Oral Health of Children
Condition: Oral Health
Study type: Interventional

Summary: 
      Prevention of dental problems by controlling plaque is the best solution to maintain oral
      health and prevent high cost of dental treatments. Home oral care is the cornerstone in
      removing plaque and therefore controlling tooth decay and gum disease. Unfortunately,
      complete plaque removal is difficult to achieve by mechanical methods alone.

      For effective plaque control antiplaque agents such as chlorhexidine mouthwash is necessary.
      Chlorhexidine has shown distinct advantage, but it has many side effects such as staining of
      the teeth and the tongue, altered taste sensation, and increased calculus formation often
      deters its use for long periods.

      Recently the use of herbal mouthwashes is rising due to the widespread awareness that natural
      substances have less side effects and lower economic cost. Of various plant extracts used as
      a base for mouthwashes, aloe vera deserves a special attention as it has recently been
      introduced in dentistry after years of use in medicine field.

      Many recent studies stated that aloe vera mouthwashes has shown efficiency in plaque control
      and prevention of gingivitis, but there is a need for more studies to determine the best
      protocols regarding concentration and frequency of its use. A review of the literature shows
      that there is no randomized controlled trials evaluating its efficiency in plaque control and
      prevention of gingivitis in children, which is the main purpose of this study.
    

Detailed description: 
      The crossover design will be adopted in this study, i.e. the three types of mouthwashes
      (experimental "aloe Vera", positive control "chlorhexidine", negative control "placebo") will
      be utilized for all participants, with an equal (5) days application period for each type of
      mouthwashes and a wash-out period of (12) days between each type to ensure the elimination of
      the effects of a mouthwash before moving to the next one.

      The evaluation areas selected for the study comprised the central maxillary incisors and the
      first maxillary molars.

      A special plaque guard will be fabricated to cover the evaluated teeth and their gingival
      margins, this plaque guard will prevent plaque removal of the evaluated teeth and facilitate
      localized plaque accumulation and the resultant gingivitis if any.

      At the start of the study, all participants will be instructed on how to brush their teeth
      properly and continue their regular oral hygiene.

      All subjects will be instructed to wear the plaque guards every time they cleaned their
      teeth, so that they will not brush the maxillary incisors and the maxillary first molars.
      This phase "the accumulation phase" will last for 3 days, and then the subjects will be
      recalled to assess the difference in plaque accumulation on the 5th day.

      The following indices will be studied: Plaque index (PI) to assess the plaque accumulation,
      gingival index (MGI),and bleeding index (BI)to assess gingivitis. These indices will be
      recorded at the first and in the 3th day. The "rinsing phase" will begin from the morning of
      day 4 and last for 5 days.

      15 ml of rinsing solution will be given to each subject who is not aware of what type of
      mouthwash he/she is receiving. Along with each bottle of mouthwash, a 10 ml syringe will be
      used to facilitate determining correct dosage. The subjects will be asked to rinse with 15 ml
      of the solution for 1 min, once daily. Intake of food and/or drinks will not be allowed for 2
      hours after rinsing. The subjects will be recalled for evaluation of plaque accumulation once
      the "rinsing phase" is completed on 8th day.
    

Intervention name(s): Aloe Vera mouthwash; Chlorhexidine mouthwash; Placebo mouthwash
Intervention type(s): Drug; Drug; Drug
Intervention description(s): rinsing with aloe vera mouthwash for 5 days.; rinsing with chlorhexidine mouthwash for 5 days.; rinsing with placebo mouthwash for 5 days.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Aloe vera mouthwash