NCT07802340

Brief Summary

This study assess the ability of Asiaticoside based Intracanal medication compared to the commonly used Intracanal medicament ( calcium hydroxide Ca(OH) 2) on the outcome of the revascularization process in immature permanent teeth with pulp necrosis

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Feb 2028

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

September 23, 2026

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

August 31, 2026

Last Update Submit

September 19, 2026

Conditions

Immature Permanent Teeth With Open ApexPulp Necrosis

Outcome Measures

Primary Outcomes (3)

  • Increase In Root Length

    Radiographic increase in root length ( Millimeters(mm))

    12 monthsl

  • Increase In Dentinal Wall Thickness

    Radiographic increase in dentinal wall thickness measured using digital image analysis (Millimeters(mm))

    12 months

  • Periapical Bone Formation

    Radiographic evidence of periapical bone formation

    12 months

Study Arms (2)

Asiaticoside

EXPERIMENTAL
Procedure: Intracanal medication

Calcium hydroxide

EXPERIMENTAL
Procedure: Intracanal medication

Interventions

Intracanal medicationPROCEDURE

Intracanal Medication for 3 weeks in Revascularization Process

AsiaticosideCalcium hydroxide

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both gender
  • patients having permanent anterior teeth with necrotic pulp and immature apex
  • Good general health
  • pulp space not needed for post and core

You may not qualify if:

  • Radiographic identification of root fracture or abnormality
  • Uncooperative patients
  • Root resorption (internal or external)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Maha Baher Hassan

CONTACT

01007987417Mahabaher23@gmail.com

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
SPONSOR

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

September 23, 2026

Record last verified: 2025-12

Locations

EG(1)