Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

Dental Caries Clinical Trial

Official title:

Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390256
• Other study ID #: REC17-030
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 10, 2020

Study information

• Verified date: May 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to evaluate:

1. The remineralization potential of natural agents (egg shell powder and clove extract) versus bioadhesive polymers (carbopol and carboxymethyl cellulose) with or without PH cycling using microhardness test.

2. The clinical efficacy of all agents in patients with early carious lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• 1. Criteria related to patient:

• Age's eligible for trial was 18- 30 years.

• Patient able to read and sign the informed consent form.

• Cooperative patient who are willing to participate and able to continue the schedule time of wok keep good oral hygiene throughout the study.

• Healthy volunteers.

• Patient with moderate and high caries index. 2. Criteria related to tooth:

• Patient with at least 2 white lesions (WSL) detected clinically on the buccal surface of permanent anterior teeth, one on each side. WSL selected either due to caries or orthodontic treatment (just following deboning).

• Teeth with score1, 2, 3 according to ICDAS II.

• Absence of preoperative pain, no mobility & tenderness on percussion.

• Radiographically, the pre-operative inclusion criteria were absence of internal or external resorption, no periapical radiolucencies and no widening of periodontal ligament space..

Exclusion Criteria:

• 1. Criteria related to patient:

• Patient with Rampant uncontrolled caries.

• Patient with compromised medical history.

• Pregnant or breast feeding females.

• Heavy smoker.

• Patient who currently received extensive fluoride regiments for treatment of WSL.

• Patients who planned to move within 3 months of enrollment.

• Patient with evidence of xerostomia. 2. Criteria related to tooth:

• Teeth with score 4, 5 according to ICDAS II.

• Teeth with periapical pathology, internal or external resorption or exhibiting any symptoms of pulp pathology.

• Teeth with questionable vitality or have root canal therapy.

• Teeth have been pulp capped.

• Teeth with periodontal pocket and bleeding on probing.

• Cracked teeth.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Clove water extract
natural product
• Carbopol
Bioadhesive polymer
• Carboxymethyle cellulose
Bioadhesive polymer

Locations

Country	Name	City	State
Egypt	Al Azhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remineralization of enamel	Remineralization of enamel using Vista scan	3 months