Clinical trial NCT04446364: Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.
Official title: Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant: A Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bacterial reduction
timeFrame: one year
Secondary outcomes:
measure: Pulp vitality
timeFrame: one year
Other outcomes:
Locations:
Study officials:
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