Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.

Dental Caries Clinical Trial

Official title:

Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant: A Split-mouth Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04446364
• Other study ID #: Ethanolic Extract of Aloe vera
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: Sara Ibrahim Hedia, M.D.S
• Phone: (0020)1157371420
• Email: sara.hedia[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Randomized Clinical Trial will be conducted to compare the efficacy of ethanolic extract of Aloe vera versus chlorhexidine cavity disinfectant in reducing total bacterial count of Streptococcus mutans (SM) and Lactobacilli (LB).

Description:

Dental caries remains to be a major oral health problem afflicting people, young and old, especially in developing and underdeveloped countries. Though dentistry has magically developed with newer materials and newer techniques, dental caries remains a disease of great prevalence.

The prevention and control of caries necessitates the elimination of cariogenic bacteria that produce acids responsible for the decrease of pH and starting the process of demineralization.

While the goal of restorative treatments for dental caries is to remove the infected dentin and fill the area with a suitable restorative material, failure to remove the infected teeth surface totally and achieve complete sterilization of the cavity can lead to microleakage, increased pulp sensitivity, pulpal infection and secondary caries that necessitate replacement of restoration.

Therefore, after removal of the carious dentin it is important to eliminate any remaining bacteria that may be present on the cavity walls, in the smear layer, at the enamel-dentin junction, or in the dentinal tubules. But unfortunately, no definitive and reliable criteria are available to ensure the complete removal of carious tooth structure. Many investigations have shown the presence of bacteria in the dentin even after removal of dye-stainable dentin.

Due to indiscriminate use of antimicrobials more and more pathogens are becoming resistant and posing a serious threat in rendering successful treatment of the diseases. With the rise in bacterial resistance to various synthetic antimicrobial agents, there is a considerable interest and a growing trend in the field.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• • Patients with at least two occlusal deep carious lesions, one on each side, preferred from the same arch.

• Age range 20-50 years.

• Systematically health.

• Adults who were able to give informed consent.

• Teeth with radiographic evidence of carious lesion that penetrated at least the inner one half of the dentin thickness.

Exclusion Criteria:

• • Patients with clinical and radiographic signs of pulpal involvement.

• Patients unable to return for recall appointments.

• Inability of a patient to give informed consent.

• Teeth with clinical and radiographic sign of pulpal involvement.

• Teeth where isolation with a rubber dam was not possible

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Ethanolic extract of Aloe vera gel cavity disinfectant
Application of Aloe vera gel after partial caries removal then taking dentin bacterial sample to be sure for reduction of bacterial count (streptococcus mutans and Lactobacillus) in deep cavity then add final restoration
• Chlorohexadine
2%Chlorohexadine add on deep cavity as cavity disinfection after partial caries removal. Pre and post excavation bacterial count to measure bacterial reduction then add final restoration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial reduction	Reduction of total bacterial count of SM and LB. IT will be measured before and after cavity disinfectant.	one year
Secondary	Pulp vitality	Pulp should be vital instead of death of pulp and loose its vitality	one year