Completed

Aloe Vera Mouthwash Impact on Plaque and Gingivitis in Children

What is being tested

Aloe Vera mouthwash

+ Chlorhexidine mouthwash

+ Placebo mouthwash

Drug

Who is being recruted

From 8 to 12 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-Controlled

Interventional

Study Start: March 2019

See protocol details

Summary

Principal SponsorDamascus University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2019

Actual date on which the first participant was enrolled.

This study focuses on understanding how Aloe Vera mouthwashes can impact plaque and gingivitis in children. The research aims to prevent these conditions by comparing Aloe Vera mouthwash with two other types: a positive control using chlorhexidine, and a negative control using a placebo. The study involves children, with a special focus on their central upper front teeth and first upper molars. The goal is to see if Aloe Vera mouthwash can help improve oral health and reduce the risk of gingivitis and caries. During the study, participants will use each type of mouthwash for 5 days, with a 12-day break between each to ensure the effects of the previous mouthwash have worn off. They will be taught how to brush their teeth properly and will wear a special plaque guard to prevent the removal of plaque from the evaluated teeth. The study will measure the amount of plaque and the condition of the gums at the start and end of each phase. Participants will rinse with 15 ml of the assigned mouthwash for 1 minute daily, and they won't be allowed to eat or drink for 2 hours after rinsing. The study will evaluate the differences in plaque accumulation and gum health after each phase to understand the effectiveness of Aloe Vera mouthwash.

Official TitleEffect of Aloe Vera Mouthwashes on Plaque and Gingivitis Indices in Children (Clinical Randomized Controlled Trial)

NCT04009616

Principal SponsorDamascus University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

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.

Show More Criteria

9 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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".

Group II

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".

Group III

Placebo

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".

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Faculty of Dental Medicine, Damascus University

Damascus, SyriaOpen Faculty of Dental Medicine, Damascus University in Google Maps

CompletedOne Study Center