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OpenTrials
Completed

NCT Number: NCT04390256

Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Azhar university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clove water extract

Other

natural product

Carbopol

Other

Bioadhesive polymer

Carboxymethyle cellulose

Other

Bioadhesive polymer

Primary outcomes

  1. Remineralization of enamel

    Time frame: 3 months

    Remineralization of enamel using Vista scan

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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