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Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars

Cairo University (CU) logo

Cairo University (CU)

Status

Enrolling

Conditions

Tooth Demineralization
Dental Caries
Teeth; Lesion
Tooth Decay
Deep Caries
Dental Restoration Failure of Marginal Integrity
Caries; Dentin
Tooth Diseases
Dental Diseases

Treatments

Other: selective caries removal and bioactive restorative system
Other: selective caries removal and conventional non-bioactive restorative system

Study type

Interventional

Funder types

Other

Identifiers

NCT06348953
Bioactive restorative system

Details and patient eligibility

About

This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context.

Full description

Deep carious lesions in permanent molars present a significant challenge in restorative dentistry. Traditional approaches to caries removal often involve the removal of excessive healthy tooth structure, leading to weakened teeth and potential pulp exposure. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue, offering a conservative alternative to traditional methods. In recent years, bioactive restorative materials have emerged as promising alternatives to conventional non-bioactive materials. Bioactive materials are designed to interact with the biological environment, promoting remineralization and potentially enhancing the longevity of restorations. However, limited evidence exists comparing the efficacy of bioactive and non-bioactive restorative systems in deep carious lesions treated with selective caries removal. This study is designed as a prospective, randomized controlled trial. Patients presenting with deep carious lesions in permanent molars will be randomly allocated to receive either a bioactive or non-bioactive restorative system following selective caries removal. Baseline demographic and clinical data will be recorded for each participant. Clinical evaluations will be conducted at regular intervals over a follow-up period of months. Outcome measures will include restoration integrity (e.g retention, marginal adaptation), pulpal response (e.g., sensitivity, vitality).

Enrollment

60 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • young adult patients (age: 18-40 years) of both genders.
  • Able to tolerate necessary restorative procedures.
  • Willing to sign the informed consent.
  • Accepts the follow-up period.
  • Posterior permanent tooth with occlusal proximal deep carious lesion.
  • Radiographically (bitewing radiograph) extending to the inner 1/3 of dentine (D3) with a radiopaque layer between the carious lesion and the pulp chamber.
  • Sensible teeth according to cold pulp test.

Exclusion criteria

  • Allergy to any restorative materials.
  • Patients undergoing orthodontic treatment with fixed appliances.
  • Pregnant women.
  • Patients with debilitating systemic diseases
  • Teeth with previous restorations.
  • Spontaneous pain or prolonged pain (more than 15 s) after sensitivity test (cold test), which would indicate irreversible pulpitis.
  • Negative sensibility tests, periapical radiolucencies and sensitivity to axial or lateral percussion.
  • Mobile teeth, indicating periodontal disease or trauma.
  • External or internal resorption.
  • Cervical carious lesions.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Conventional non-bioactive restorative system (Comparator)
Active Comparator group
Description:
deep carious molars restored with conventional resin based restorative system
Treatment:
Other: selective caries removal and conventional non-bioactive restorative system
Bioactive system (Intervention)
Active Comparator group
Description:
deep carious molars restored with bioactive resin based restorative system
Treatment:
Other: selective caries removal and bioactive restorative system

Trial contacts and locations

1

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Central trial contact

ahmed M adam, Mcs

Data sourced from clinicaltrials.gov

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