Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

NCT ID: NCT04390256

Last Updated: 2020-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-05-10

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Egg shell powder nanoparticles

Group Type ACTIVE_COMPARATOR

Clove water extract

Intervention Type OTHER

natural product

Carbopol

Intervention Type OTHER

Bioadhesive polymer

Carboxymethyle cellulose

Intervention Type OTHER

Bioadhesive polymer

Clove water extract

Group Type EXPERIMENTAL

Clove water extract

Intervention Type OTHER

natural product

Carbopol

Intervention Type OTHER

Bioadhesive polymer

Carboxymethyle cellulose

Intervention Type OTHER

Bioadhesive polymer

Carbopol

Group Type EXPERIMENTAL

Clove water extract

Intervention Type OTHER

natural product

Carbopol

Intervention Type OTHER

Bioadhesive polymer

Carboxymethyle cellulose

Intervention Type OTHER

Bioadhesive polymer

Carboxymethyle cellulose

Group Type EXPERIMENTAL

Clove water extract

Intervention Type OTHER

natural product

Carbopol

Intervention Type OTHER

Bioadhesive polymer

Carboxymethyle cellulose

Intervention Type OTHER

Bioadhesive polymer

Interventions

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Clove water extract

natural product

Intervention Type OTHER

Carbopol

Bioadhesive polymer

Intervention Type OTHER

Carboxymethyle cellulose

Bioadhesive polymer

Intervention Type OTHER

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed

Ass. lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Azhar university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC17-030

Identifier Type: -

Identifier Source: org_study_id

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