A Comparative Study of Different Traditional and Bioactive Indirect Pulp Capping Materials

A Comparative Study of Different Traditional and Bioactive Indirect Pulp Capping Materials on Dentin Hypersensitivity.In-vivo Study

The protection of the dentin-pulp complex consists of the application of one or more layers of specific material between the restorative material and dental tissue to avoid additional challenge to the pulp tissue caused by operative procedures, toxicity of restorative materials and bacteria penetration due to microleakage. Protection of the dentinpulp complex has also the function to recover pulp vitality.The materials that can be used for this purpose are varnishes,calcium hydroxide (CH)-based products, glass ionomer cements (GICs) and adhesive systems.The biological compatibility together with the sealing capabilities of dental materials is of paramount importance to avoid or limit pulp tissue irritation and dentinal hypersensitivity.

Study Overview

• Status: Completed
• Conditions: Deep Carious Lesions; Caries Class II; Caries Class I
• Intervention / Treatment: Other: patients received calcium hydroxide with glass ionomer restorative material; Other: patients received TheraCal LC with glass ionomer restorative material; Other: patients received universal bonding with glass ionomer restorative material; Other: patients received bioactive bonding with glass ionomer restorative material

Detailed Description

Pulp plays an important role in the formation and nutrition of dentin as well as in the innervation and defense of the teeth. The primary pulp function is dentin formation, which begins in the moment that the peripheric mesenchimal cells differentiate into odontoblasts and starts the deposition of collagen matrix, in a sequence of deposition/mineralization that ends with the complete tooth formation. Even after the initial formation, pulp continues to physiologically produce dentin due to the tooth aging. Reparative dentin may also be produced in response to physical and/or chemical injuries. Odontoblasts maintain their processes inside the newly formed tissue, thus creating real channels that are responsible for dentin nutrition. changes in the flow of the fluid in the dentinal tubules can trigger pain receptors present on nerve endings in the pulpal aspect to fire nerve impulses, thereby causing pain . This hydrodynamic flow can be increased by changes in temperature, humidity, air pressure and osmotic pressure, or forces acting on the tooth. Hot or cold foods and drinks, and physical pressure are typical triggers in people with dentin hypersensitivity.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Badr University in Cairo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient's age ranges from 20-50 years old with vital first permanent molar tooth on testing by vitality test, such as thermal or electrical pulp tester.
2. Class I or II cavities.
3. Deep carious lesions.
4. Absence of clinical signs or symptoms suggesting non-vital tooth such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.
5. Sufficient tooth structure for restoration.
6. Healthy patients with good general health.
7. Patients are cooperative and motivated.

Exclusion Criteria:

1. Patient with systemic diseases such as uncontrolled diabetic, cardiovascular diseases, or patient received chemotherapy or radiotherapy.
2. History of spontaneous, unprovoked toothache or mobility, (grade I, II and III).
3. Sensitivity to percussion, external or internal root resorption, periapical lesions or presence of a fistulae.
4. Pregnant females.
5. Drug abuser patients.
6. Previously restored teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patients received calcium hydroxide with resin composite; patients received calcium hydroxide lining material then restored with resin composite	Other: patients received calcium hydroxide with glass ionomer restorative material; patients received calcium hydroxide with glass ionomer restorative material
Active Comparator: patients received TheraCal LC with resin composite; patients received TheraCal LC lining material then restored with resin composite	Other: patients received TheraCal LC with glass ionomer restorative material; patients received TheraCal LC with glass ionomer restorative material
Active Comparator: patients received universal bonding with resin composite; patients received universal bonding as lining material then restored with resin composite	Other: patients received universal bonding with glass ionomer restorative material; patients received bioactive bonding with glass ionomer restorative material
Active Comparator: patients received bioactive bonding with resin composite; patients received bioactive bonding as lining material then restored with resin composite	Other: patients received bioactive bonding with glass ionomer restorative material; patients received bioactive bonding with glass ionomer restorative material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative hypersensitivity	Quantitative Assessment by using Verbal analogue scale scoring from 0 - 4 where 0 indicates no pain and 4 indicates intensifying pain	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evaluation	Patients in all the eight groups were evaluated clinically and radiographically immediately after the procedure,1 week,1 month , 3 months and 6 months using the following criteria: (1) absence of spontaneous pain and/or sensitivity to pressure; (2) absence of sinus, fistula, edema, and/or abnormal mobility; (3) absence of radiolucency at the interradicular and/or periapical regions; (4) absence of internal or external root resorption.	6 month

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Badr University
• Investigators: Principal Investigator: Ahmed A Abdelaziz, PhD, Badr University in Cairo

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 23, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 23, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Adrenergic Agents; Central Nervous System Stimulants; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Adrenergic Uptake Inhibitors; Sympathomimetics; Calcium; Methamphetamine
• Other Study ID Numbers: BUC-IACUC-240623-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No