Comparison Between Emdogain and Amniotic Membrane as a Scaffold in Endodontic Regeneration of Immature Anterior Teeth

NCT ID: NCT07252167

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-04-01

Brief Summary

To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative and amniotic membrane in regenerative endodontic treatment of non-vital immature permanent anterior teeth

Detailed Description

To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative in comparison to amniotic membrane and MTA as a conventional group in regenerative endodontic treatment of non-vital immature permanent anterior teeth

Conditions

Non-vital Immature Anterior Teeth

Study Design

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

Study Groups

Regenerative endodontic treatment using MTA

Regenerative endodontic treatment with conventional blood clot technique.

Group Type: EXPERIMENTAL

Regenerative endodontic treatment with conventional blood clot technique.

Intervention Type: OTHER

After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.

Regenerative endodontic treatment using emdogain

regenerative endodontic treatment with emdogain

Group Type: EXPERIMENTAL

regenerative endodontic treatment with emdogain.

Intervention Type: OTHER

• After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Emdogain is injected inside the canal on the blood clot up to the CEJ to act as a matrix for the cells. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.

Regenerative endodontic treatment using amniotic membrane

regenerative endodontic treatment with amniotic membrane

Group Type: OTHER

regenerative endodontic treatment with amniotic membrane

Intervention Type: OTHER

\- After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Amniotic membrane will adapted inside the canal on the blood clot up to the CEJ. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.

Interventions

Regenerative endodontic treatment with conventional blood clot technique.

After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.

Intervention Type: OTHER

regenerative endodontic treatment with emdogain.

• After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Emdogain is injected inside the canal on the blood clot up to the CEJ to act as a matrix for the cells. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.

Intervention Type: OTHER

regenerative endodontic treatment with amniotic membrane

\- After local anesthesia, rubber dam isolation and access cavity preparation, pulp tissue extirpation/debridement, the root canal system is minimally instrumented. Copious irrigation is performed, gently with single-side vented needles. Canals are dried with paper points. Metapaste is injected as intracanal medication. At second session, check for absence of signs/symptoms. Copious gentle irrigation and drying of canals with paper points is done. Bleeding is created in root canal by over-instrumentation until bleeding is evident in the cervical portion of the canal. A lightly moistened sterile cotton pellet is placed into the canal, 3-4 mm apical to the CEJ, for 7-10 minutes to allow blood clot formation. Amniotic membrane will adapted inside the canal on the blood clot up to the CEJ. Placement of MTA over the blood clot as a capping material. A 3-4 mm layer of glass ionomer is gently placed over the capping material. Followed by resin composite restoration.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

•Patients age ranges between 7 and 12 years at the time of enrolment including both genders. •Provision of informed consent by one parent or legal guardian. •At least one immature permanent anterior tooth diagnosed with pulp necrosis with or without periapical lesions. •Restorable teeth. •Compliant patient/parent. •Radiologic evidence of open apices (Teeth are considered immature when a minimum of 1 mm apical foramen width is evident)

Exclusion Criteria

•Teeth with root fractures or split roots. •Presence of root resorptions. •Presence of periodontal pockets. •Developmental anomalies. •Presence of periapical radiolucency of more than 10 mm. •Tooth with class III mobility.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Abrar Hamed Habib Yousef

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al Azhar university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Endodontic regeneration

Identifier Type: -

Identifier Source: org_study_id