Oral HealthNCT04009616
Effect of Aloe Vera Mouthwashes on the Oral Health of Children
A study testing Aloe Vera mouthwash and Chlorhexidine mouthwash in people with Oral Health, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Aloe Vera mouthwash and Chlorhexidine mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSyria
- Study dates
- 1 Mar 2019to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aloe Vera Mouthwashes on Plaque and Gingivitis Indices in Children (Clinical Randomized Controlled Trial)
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.
Read more
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.
Read the 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.
- Conditions
- Oral Health
- Being tested
- Aloe Vera mouthwash, Chlorhexidine mouthwash, Placebo mouthwash
- Keywords
- Aloe vera mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe Vera mouthwashDrug
rinsing with aloe vera mouthwash for 5 days.
Chlorhexidine mouthwashDrug
rinsing with chlorhexidine mouthwash for 5 days.
Placebo mouthwashDrug
rinsing with placebo mouthwash for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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". Receives: 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". Receives: Drug: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Assessment will be performed using questionnaire that includes Visual Analog Scale (VAS) for each question, the scale has a minimum scale of 0 (no discomfort) and a maximum scale of 100 (maximum discomfort).
Measured: at the end of each mouthwash experimental phase (8th day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Mar 2019
- Primary completion30 Jun 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doaa Adnan Alnouri, DDS, Msc Student, Principal investigator, Department of Pediatric Dentistry, Faculty of Dental Medicine, Damascus University, Damascus, SyriaChaza Kouchaji, Professor, Study chair, Department of Pediatric Dentistry, Faculty of Dental Medicine, Damascus University, Damascus, SyriaAbdul Hakim Nattouf, Professor, Study chair, Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009616
- Sponsor's protocol ID
- UDDS-Pedo-01-2020
- Status last verified
- Apr 2020
- First submitted
- 25 Jun 2019
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24174720Gupta 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.
PubMed 24795515Manipal 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.
PubMed 27437366Pilloni 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.
PubMed 22238712Saha 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.
PubMed 25737862
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aloe Vera Mouthwashes on Plaque and Gingivitis Indices in Children (Clinical Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT04009616
- Acronym / sponsor ID
- UDDS-Pedo-01-2020
- Conditions
- Oral Health
- Keywords
- Aloe vera mouthwash
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aloe Vera mouthwash | Experimental | Drug: Aloe Vera mouthwashplaque 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". |
| Chlorhexidine mouthwash | Experimental | Drug: Chlorhexidine mouthwashplaque 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". |
| Placebo mouthwash | Placebo comparator | Drug: Placebo mouthwashplaque 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". |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aloe Vera mouthwashrinsing with aloe vera mouthwash for 5 days. | Drug | Aloe Vera mouthwash |
| Chlorhexidine mouthwashrinsing with chlorhexidine mouthwash for 5 days. | Drug | Chlorhexidine mouthwash |
| Placebo mouthwashrinsing with placebo mouthwash for 5 days. | Drug | Placebo mouthwash |
Primary outcome
Effect of Aloe vera mouthwashes on plaque index
Time frame: before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)
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.
Effect of Aloe vera mouthwashes on gingival index
Time frame: before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)
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.
Effect of Aloe vera mouthwashes on gingival bleeding index
Time frame: before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)
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.
1 secondary outcome
the level of receptivity and discomfort and side effects of the Aloe vera mouthwashes.
Time frame: at the end of each mouthwash experimental phase (8th day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 24174720Ajmera 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.
- Background: PubMed 24795515Gupta 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.
- Background: PubMed 27437366Manipal 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.
- Background: PubMed 22238712Pilloni 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.
- Background: PubMed 25737862Saha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa Adnan Alnouri, DDS, Msc Student principal investigator
Department of Pediatric Dentistry, Faculty of Dental Medicine, Damascus University, Damascus, Syria
Chaza Kouchaji, Professor study chair
Department of Pediatric Dentistry, Faculty of Dental Medicine, Damascus University, Damascus, Syria
Abdul Hakim Nattouf, Professor study chair
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aloe Vera mouthwash and Chlorhexidine mouthwash in people with Oral Health, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Aloe vera mouthwashes on plaque index (time frame: before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04009616, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.