Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.

NCT ID: NCT04446364

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-09-01

Brief 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).

Detailed 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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aloe vera group

Gel cavity disinfection

Group Type: EXPERIMENTAL

Ethanolic extract of Aloe vera gel cavity disinfectant

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Chlorohexidine group

2% cavity disinfection

Group Type: ACTIVE_COMPARATOR

Ethanolic extract of Aloe vera gel cavity disinfectant

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Other Intervention Names

Aloe vera

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Ibrahim Ahmed Hedia

Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sara Ibrahim Hedia, M.D.S

Role: CONTACT

sara.hedia@dentistry.cu.edu.eg

(0020)1157371420

Rasha Raafat Hassan, Assistant Proffesor

Role: CONTACT

Rasha.Raafat@dentistry.cu.edu.eg

(0020)1006555335

Other Identifiers

Ethanolic Extract of Aloe vera

Identifier Type: -

Identifier Source: org_study_id