Clinical Evaluation and Cone Beam Computed Tomography Analysis of Different Biomaterials for Apexogenesis of Immature Permanent Molars

NCT ID: NCT07336498

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-04-01

Brief Summary

The present study will be conducted to clinically evaluation and cone beam computed tomography analysis of amniotic membrane, putty mineral trioxide aggregate and biodentine as therapeutic agents for apexogenesis of immature permanent molars

Detailed Description

An immature permanent tooth is defined as, a newly erupted permanent tooth with incomplete root apex formation. Since root development is completed in 2-3 years after tooth eruption into the oral cavity, loss of pulp vitality in the immature permanent tooth affected by caries, traumatic injury, or other causes creates major problems. The primary goal of pulp therapy is to maintain the integrity of the teeth while maintaining the vitality of the pulp, especially in young permanent teeth with immature roots to enhance root dentin formation. An increasingly popular therapy option for pulp damage in immature permanent molars is apexogenesis. Vital pulp therapy involves the complete removal of the coronal pulp and the placement of an acceptable material into the pulp chamber. With the invention of calcium silicate material namely mineral trioxide aggregate (MTA), it became preferred to calcium hydroxide in the treatment of exposed pulp. MTA demonstrated excellent biocompatibility, low solubility, outstanding sealing properties and antibacterial effect. However, MTA has some limitations regarding the long setting time and difficult handling. Premixed calcium silicate cements were developed to facilitate manipulation with no need for mixing, such as using the putty formulation which allows better handling with a thicker consistency Additionally, Biodentine was introduced as a tricalcium silicate-based bioceramic, with comparable physical properties to dentine, thus, it is also called dentine replacement material and has applications like those of MTA. Considering the limitations of MTA, biodentine has been developed with enhanced physicochemical properties such as a fast-setting time with an initial setting time between 9 and 12 minutes due to the presence of calcium chloride. Its short setting time allows restoration to be made in one session with easier chairside handling than MTA. Recently, novel biologically based material has been developed from the innermost layer of the placenta with highly rich stem cell reservoirs and is called amniotic membrane. The amniotic membrane is rich in growth factors, various types of collagens (such as types I, III, IV, V, and VII), along with proteoglycans, elastin and hyaluronic acid. It possesses a range of beneficial properties, including anti-inflammatory, antimicrobial and analgesic which make it a unique option for wound healing, providing a supportive environment that promotes the survival and proliferation of mesenchymal progenitor cells. In dentistry, researchers supported its application in regenerative endodontic therapy by providing a growth factors that promote stem cell growth and formation of a new dentine-pulp complex. Therefore, in the present study, clinical and radiographic evaluation will be done to assess the effectiveness of different biomaterials in managing immature permanent tooth with pulp exposure.

Conditions

Vital Pulp Therapy in Young Permanent Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biodentine will be placed directly in the pulp chamber

Group Type: EXPERIMENTAL

Vital pulp therapy of immature permanent teeth

Intervention Type: PROCEDURE

Conventional access cavity will be done with a high-speed bur using copious water spray. The coronal pulp amputation will be performed using a sharp spoon excavator. In order to achieve hemostasis sterilized cotton pellet moistened with sterile saline will be placed over the pulp's stumps for 5 minutes, followed by application of the therapeutic agent. The prepared cavities of all molars will be sealed with a layer of glass ionomer over the therapeutic agents and subsequently will be covered with composite resin restoration.

Previously trimmed amniotic membrane will be placed directly in the pulp chamber

Group Type: EXPERIMENTAL

Vital pulp therapy of immature permanent teeth

Intervention Type: PROCEDURE

Conventional access cavity will be done with a high-speed bur using copious water spray. The coronal pulp amputation will be performed using a sharp spoon excavator. In order to achieve hemostasis sterilized cotton pellet moistened with sterile saline will be placed over the pulp's stumps for 5 minutes, followed by application of the therapeutic agent. The prepared cavities of all molars will be sealed with a layer of glass ionomer over the therapeutic agents and subsequently will be covered with composite resin restoration.

Putty MTA will be placed directly in the pulp chamber

Group Type: OTHER

Vital pulp therapy of immature permanent teeth

Intervention Type: PROCEDURE

Conventional access cavity will be done with a high-speed bur using copious water spray. The coronal pulp amputation will be performed using a sharp spoon excavator. In order to achieve hemostasis sterilized cotton pellet moistened with sterile saline will be placed over the pulp's stumps for 5 minutes, followed by application of the therapeutic agent. The prepared cavities of all molars will be sealed with a layer of glass ionomer over the therapeutic agents and subsequently will be covered with composite resin restoration.

Interventions

Vital pulp therapy of immature permanent teeth

Conventional access cavity will be done with a high-speed bur using copious water spray. The coronal pulp amputation will be performed using a sharp spoon excavator. In order to achieve hemostasis sterilized cotton pellet moistened with sterile saline will be placed over the pulp's stumps for 5 minutes, followed by application of the therapeutic agent. The prepared cavities of all molars will be sealed with a layer of glass ionomer over the therapeutic agents and subsequently will be covered with composite resin restoration.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Healthy patients without any systemic disease aged 7 to 10 years old.
• Vital immature permanent molars with deep carious lesions.
• Restorable tooth
• No clinical signs and symptoms of irreversible pulpitis including spontaneous pain, tenderness to percussion, swelling or sinus tract.
• No radiographic evidence of periapical abscess, internal or external resorption.

Exclusion Criteria

• Patients with known allergies to any of the dental materials to be used.
• Bleeding could not be controlled within 5 minutes after complete pulpotomy
• Teeth with root fractures
• Carious furcation involvement

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mohamed Ezz Eldeen Ghareep

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Al-Azhar University, Cairo (Boys Branch)

Cairo, , Egypt

Countries

Egypt

References

Duncan HF, Nagendrababu V, El-Karim IA, Dummer PMH. Outcome measures to assess the effectiveness of endodontic treatment for pulpitis and apical periodontitis for use in the development of European Society of Endodontology (ESE) S3 level clinical practice guidelines: a protocol. Int Endod J. 2021 May;54(5):646-654. doi: 10.1111/iej.13501. Epub 2021 Mar 15.

Reference Type: BACKGROUND

PMID: 33630330 (View on PubMed)

Dentistry AAoP. Pulp therapy for primary and immature permanent teeth. The Reference Manual of Pediatric Dentistry Chicago, Ill: American Academy of Pediatric Dentistry. 2021;399407.

Reference Type: BACKGROUND

Other Identifiers

EC 1163/6935

Identifier Type: -

Identifier Source: org_study_id