Effect of Aloe Vera Mouthwashes on the Oral Health of Children

NCT04009616 | Completed

• 1 other identifier: UDDS-Pedo-01-2020
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Health

Keywords

Aloe vera mouthwash

Outcome Measures

Primary Outcomes (3)

• Effect of Aloe vera mouthwashes on plaque index

  this variable will be measured by calculating the difference between the index studied at the beginning and end of the experimental phase, to evaluate children's oral health and know the probability to have caries later.

  before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)

• Effect of Aloe vera mouthwashes on gingival index

  this variable will be measured by calculating the difference between the index studied at the beginning and end of the experimental phase, to evaluate children's gingival health and know the probability to have gingivitis later.

  before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)

• Effect of Aloe vera mouthwashes on gingival bleeding index

  this variable will be measured by calculating the difference between the index studied at the beginning and end of the experimental phase, to evaluate children's gingival health and know the probability to have gingivitis later.

  before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)

Secondary Outcomes (1)

• the level of receptivity and discomfort and side effects of the Aloe vera mouthwashes.

  at the end of each mouthwash experimental phase (8th day)

Study Arms (3)

Aloe Vera mouthwash

EXPERIMENTAL

plaque accumulation and gingivitis will be evaluated before and after giving aloe vera mouthwash by studying plaque, gingival and bleeding indices. the plaque will be accumulated for 3 days "accumulation phase" before applying aloe vera mouthwash for 5 days "rinsing phase".

Drug: Aloe Vera mouthwash

Chlorhexidine mouthwash

EXPERIMENTAL

plaque accumulation and gingivitis will be evaluated before and after giving chlorhexidine mouthwash by studying plaque, gingival and bleeding indices. the plaque will be accumulated for 3 days "accumulation phase" before applying chlorhexidine mouthwash for 5 days "rinsing phase".

Drug: Chlorhexidine mouthwash

Placebo mouthwash

PLACEBO COMPARATOR

plaque accumulation and gingivitis will be evaluated before and after giving placebo mouthwash by studying plaque, gingival and bleeding indices. the plaque will be accumulated for 3 days "accumulation phase" before applying placebo mouthwash for 5 days "rinsing phase".

Drug: Placebo mouthwash

Interventions

Aloe Vera mouthwash DRUG

rinsing with aloe vera mouthwash for 5 days.

Aloe Vera mouthwash

Chlorhexidine mouthwash DRUG

rinsing with chlorhexidine mouthwash for 5 days.

Chlorhexidine mouthwash

Placebo mouthwash DRUG

rinsing with placebo mouthwash for 5 days.

Placebo mouthwash

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient ages between (8 - 12) years.
• Healthy children without any systemic medical conditions.
• Good oral health (no manifestations of oral diseases on the mucous membranes).
• The presence of the maxillary first permanent molars and the maxillary central incisors.
• No caries on the buccal and lingual surfaces of the teeth.
• Cooperative children (positive or definitely positive on Frankl's behavior rating scale).
• The patient has the physiological ability to use the mouthwashes, This will be confirmed by asking the child's parent first and then test his/her ability to rinse with water before being enrolled in the study.

You may not qualify if:

• Children with systemic medical conditions.
• Patients undergoing current dental or orthodontic treatment.
• Patients who used any other mouthwash during the study period or were given antibiotic therapy within 2 weeks before starting the study or corticosteroids within 30 days before starting the study.
• Patients who use removable prosthetic or orthodontic appliances.
• Patients who have gingival pockets more than (3) mm or advanced gingival diseases.
• Fluorescent patients.
• Patients who have a sensitivity story for any element of the mouthwashes used in the study.
• Patients who underwent an extraction within two weeks of starting the study.
• Patient lack of commitment toward follow-up appointments.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Faculty of Dental Medicine, Damascus University

Damascus, Syria

Location

Related Publications (5)

• Ajmera N, Chatterjee A, Goyal V. Aloe vera: It's effect on gingivitis. J Indian Soc Periodontol. 2013 Jul;17(4):435-8. doi: 10.4103/0972-124X.118312.

  PMID: 24174720 BACKGROUND

• Gupta RK, Gupta D, Bhaskar DJ, Yadav A, Obaid K, Mishra S. Preliminary antiplaque efficacy of aloe vera mouthwash on 4 day plaque re-growth model: randomized control trial. Ethiop J Health Sci. 2014 Apr;24(2):139-44. doi: 10.4314/ejhs.v24i2.6.

  PMID: 24795515 BACKGROUND

• Manipal S, Hussain S, Wadgave U, Duraiswamy P, Ravi K. The Mouthwash War - Chlorhexidine vs. Herbal Mouth Rinses: A Meta-Analysis. J Clin Diagn Res. 2016 May;10(5):ZC81-3. doi: 10.7860/JCDR/2016/16578.7815. Epub 2016 May 1.

  PMID: 27437366 BACKGROUND

• Pilloni A, Pizzo G, Barlattani A, Di Lenarda R, Giannoni M, Guida L, Levrini L, Majorana A, Polimeni A. Perceived and measurable performance of daily brushing and rinsing with an essential oil mouthrinse. Ann Stomatol (Roma). 2010 Jul;1(3-4):29-32. Epub 2011 Feb 13.

  PMID: 22238712 BACKGROUND

• Saha S, Mohammad S, Saha S, Samadi F. Efficiency of traditional chewing stick (miswak) as an oral hygiene aid among Muslim school children in Lucknow: A cross-sectional study. J Oral Biol Craniofac Res. 2012 Sep-Dec;2(3):176-80. doi: 10.1016/j.jobcr.2012.10.009. Epub 2012 Oct 24.

  PMID: 25737862 BACKGROUND

Study Officials

• Doaa Adnan Alnouri, DDS, Msc Student

  Department of Pediatric Dentistry, Faculty of Dental Medicine, Damascus University, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Chaza Kouchaji, Professor

  Department of Pediatric Dentistry, Faculty of Dental Medicine, Damascus University, Damascus, Syria

  STUDY CHAIR

• Abdul Hakim Nattouf, Professor

  Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 5, 2019
• Study Start: March 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: August 30, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)