Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04390256
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4
• Actual Duration (Months): 35.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: Clove water extract; Other: Carbopol; Other: Carboxymethyle cellulose	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Jan 10, 2020
• Actual Study Completion Date: May 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Egg shell powder nanoparticles	Other: Clove water extract; natural product; Other: Carbopol; Bioadhesive polymer; Other: Carboxymethyle cellulose; Bioadhesive polymer
Experimental: Clove water extract	Other: Clove water extract; natural product; Other: Carbopol; Bioadhesive polymer; Other: Carboxymethyle cellulose; Bioadhesive polymer
Experimental: Carbopol	Other: Clove water extract; natural product; Other: Carbopol; Bioadhesive polymer; Other: Carboxymethyle cellulose; Bioadhesive polymer
Experimental: Carboxymethyle cellulose	Other: Clove water extract; natural product; Other: Carbopol; Bioadhesive polymer; Other: Carboxymethyle cellulose; Bioadhesive polymer

Outcome Measures

Primary Outcome Measures

1. Remineralization of enamel [3 months]

   Remineralization of enamel using Vista scan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Azhar university	Cairo		Egypt

Sponsors and Collaborators

• Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marwa Mohamed, Ass. lecturer, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT04390256
• Other Study ID Numbers: REC17-030
• First Posted: May 15, 2020
• Last Update Posted: May 15, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of May 15, 2020