Partial Caries Removal in Permanent Molars Restored Using Giomer

NCT06601972 | Not Yet Recruiting

• 1 other identifier: giomervscomp
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dental manufacturers\' constant tweaks and improvements to composite compositions have resulted in a wider spectrum of restorative materials with positive long-term clinical performance. For example, the creation of bioactive giomer material with proven continuous multi-ion release has been beneficial in avoiding demineralization and imparting acid resistance to enamel and dentin.

Conditions

Caries, Dental

Keywords

partial caries removal; bioactive; giomer

Outcome Measures

Primary Outcomes (1)

• Success rate

  The primary outcome of the present clinical trial is success rate, expressed as a binary variable indicating whether the restored tooth maintained its pulp vitality after 24 months. Success will be evaluated by a positive response to cold pulp testing, absence of spontaneous pain, no tenderness to percussion, absence of periapical radiolucency.

  From enrollment to the end of treatment at 24 months

Secondary Outcomes (1)

• Dentin bridge formation

  From enrollment to the end of treatment at 24 months

Study Arms (2)

Giomer

EXPERIMENTAL

Low-shrinkage bioactive material

Procedure: Beautifil II LS (Low-Shrinkage)

Nanohybrid composite

ACTIVE COMPARATOR

Universal Nano-hybrid composite

Procedure: Nanohybrid resin composite

Interventions

Beautifil II LS (Low-Shrinkage) PROCEDURE

The most remarkable feature of this light-cured universal composite for anterior and posterior restorations is its unique shrinkage of 0.85 percent by volume

Giomer

Nanohybrid resin composite PROCEDURE

Nanohybrid resin composites are the most popular, because they improve the distribution of fillers in the matrix by combining nanoparticles with submicron particles to achieve better mechanical, chemical, and optical properties

Nanohybrid composite

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years.
• Not received antibiotic therapy since 1 month before sampling.
• Males or Females (Both genders).
• Co-operative patients approving the trial.
• Good to fair oral hygiene
• Class I cavitated lesions in permanent molars (reaching \>1/2 of the dentin on radiographic examination)
• Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).

You may not qualify if:

• known allergic reaction to resinous materials.
• Systemic disease or severe medical complications.
• Periodontal problem.
• Bruxism
• Poor oral hygiene
• Class II caries lesion
• Shallow or enamel caries
• Teeth with periapical lesions.
• Mobile teeth, arrest caries and non-vital teeth

Sponsors & Collaborators

• NewGiza University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Omar O Shaalan, PhD

CONTACT

+201122665661; omar.shaalan@ngu.edu.eg

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: Associate professor of conservative dentistry

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share