NCT04390256

Brief Summary

This study will be conducted to evaluate:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

May 12, 2020

Last Update Submit

May 12, 2020

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Remineralization of enamel

    Remineralization of enamel using Vista scan

    3 months

Study Arms (4)

Egg shell powder nanoparticles

ACTIVE COMPARATOR
Other: Clove water extractOther: CarbopolOther: Carboxymethyle cellulose

Clove water extract

EXPERIMENTAL
Other: Clove water extractOther: CarbopolOther: Carboxymethyle cellulose

Carbopol

EXPERIMENTAL
Other: Clove water extractOther: CarbopolOther: Carboxymethyle cellulose

Carboxymethyle cellulose

EXPERIMENTAL
Other: Clove water extractOther: CarbopolOther: Carboxymethyle cellulose

Interventions

Clove water extractOTHER

natural product

CarbopolCarboxymethyle celluloseClove water extractEgg shell powder nanoparticles
CarbopolOTHER

Bioadhesive polymer

CarbopolCarboxymethyle celluloseClove water extractEgg shell powder nanoparticles
Carboxymethyle celluloseOTHER

Bioadhesive polymer

CarbopolCarboxymethyle celluloseClove water extractEgg shell powder nanoparticles

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

carboxypolymethylene

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. lecturer

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 15, 2020

Study Start

June 1, 2017

Primary Completion

January 10, 2020

Study Completion

May 10, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

EG(1)