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

NCT06707311 | Completed

• 1 other identifier: BUC-IACUC-240623-102
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Carious Lesions; Caries Class I; Caries Class II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographic evaluation

  6 month

Study Arms (4)

patients received calcium hydroxide with resin composite

ACTIVE COMPARATOR

patients received calcium hydroxide lining material then restored with resin composite

Other: patients received calcium hydroxide with glass ionomer restorative material

patients received TheraCal LC with resin composite

ACTIVE COMPARATOR

patients received TheraCal LC lining material then restored with resin composite

Other: patients received TheraCal LC with glass ionomer restorative material

patients received universal bonding with resin composite

ACTIVE COMPARATOR

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 resin composite

ACTIVE COMPARATOR

patients received bioactive bonding as lining material then restored with resin composite

Other: patients received bioactive bonding with glass ionomer restorative material

Interventions

patients received calcium hydroxide with glass ionomer restorative material OTHER

patients received calcium hydroxide with glass ionomer restorative material

patients received calcium hydroxide with resin composite

patients received TheraCal LC with glass ionomer restorative material OTHER

patients received TheraCal LC with glass ionomer restorative material

patients received TheraCal LC with resin composite

patients received bioactive bonding with glass ionomer restorative material OTHER

patients received bioactive bonding with glass ionomer restorative material

patients received bioactive bonding with resin composite

patients received universal bonding with glass ionomer restorative material OTHER

patients received bioactive bonding with glass ionomer restorative material

patients received universal bonding with resin composite

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Class I or II cavities.
• Deep carious lesions.
• 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.
• Sufficient tooth structure for restoration.
• Healthy patients with good general health.
• Patients are cooperative and motivated.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Badr University: collaborator

Study Sites (1)

Badr University in Cairo

Cairo, Egypt

Location

Study Officials

• Ahmed A Abdelaziz, PhD

  BADR University in Cairo

  PRINCIPAL INVESTIGATOR

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: Lecturer in BADR University

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 27, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)