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Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Clove water extract

Carbopol

Carboxymethyle cellulose

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Al Azhar university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Egg shell powder nanoparticles

Clove water extract

Carbopol

Carboxymethyle cellulose

Arm Description

Outcomes

Primary Outcome Measures

Remineralization of enamel

Remineralization of enamel using Vista scan

Secondary Outcome Measures

Full Information

NCT ID

NCT04390256

First Posted

May 12, 2020

Last Updated

May 12, 2020

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT04390256

Brief Title

Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

Official Title

Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

January 10, 2020 (Actual)

Study Completion Date

May 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will be conducted to evaluate: 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. The clinical efficacy of all agents in patients with early carious lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Egg shell powder nanoparticles

Arm Type

Active Comparator

Arm Title

Clove water extract

Arm Type

Experimental

Arm Title

Carbopol

Arm Type

Experimental

Arm Title

Carboxymethyle cellulose

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Clove water extract

Intervention Description

natural product

Intervention Type

Other

Intervention Name(s)

Carbopol

Intervention Description

Bioadhesive polymer

Intervention Type

Other

Intervention Name(s)

Carboxymethyle cellulose

Intervention Description

Bioadhesive polymer

Primary Outcome Measure Information:

Title

Remineralization of enamel

Description

Remineralization of enamel using Vista scan

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Al Azhar university

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

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