NCT06006052

Brief Summary

Compare the clinical and radiographic outcomes of demineralized dentin matrix scaffold to blood clot scaffold in immature permanent incisors with non-vital pulps for one year (in vivo). Investigate the effect of demineralized dentin matrix (DDM) on dental pulp stem cells (DPSCs) (in vitro).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

July 30, 2023

Last Update Submit

August 16, 2023

Conditions

Dental Trauma

Outcome Measures

Primary Outcomes (1)

  • the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month

    no history of pain, using Visual Analog Score for pain, measure quality of life. soft tissue swelling or sinus tract by visual examination , Sensitivity to percussion, Tooth mobility by clinical assessment by operator

    at 0,3 and 6 and 9and 12 month

Secondary Outcomes (1)

  • change root wall thickness and root length in radiographic measurement in millimeter at 0,3,6,9,12 month

    at 0, 3 and 6 and 9and 12 month

Other Outcomes (1)

  • change root wall thickness and root length using CBCT millimeter at base line and after 12 month

    at base line and after 12 month

Study Arms (3)

study group DDM

EXPERIMENTAL

Group I: 10 teeth will be treated with demineralized dentin matrix attached to collagen membrane as a scaffold in the regenerative endodontic procedure.

Combination Product: regeneration technique

Control group

ACTIVE COMPARATOR

Group II: 10 teeth will be treated with the conventional regenerative endodontic procedure (blood clot scaffold).

Combination Product: regeneration technique

positive control

ACTIVE COMPARATOR

Group III: 10 teeth will be treated with collage membrane as a scaffold in the regenerative endodontic procedure

Combination Product: regeneration technique

Interventions

regeneration techniqueCOMBINATION_PRODUCT

clinical procedure of regenerative endodontic as AAE mentioned using different material in each group

Also known as: regenerative endodontic
Control grouppositive controlstudy group DDM

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 7-13years at the time of enrolment.
  • Provision of informed consent by one parent or legal guardian.
  • At least the patents have one immature permanent anterior tooth diagnosed with irreversible pulpitis or pulp necrosis with or without periapical lesions.
  • Restorable teeth ,clinical crown should be enough to use rapper dam Compliant patient/parent.
  • Patients are not allergic to medicaments and antibiotics necessary to complete the procedure (ASA 1 or 2).
  • Radiologic evidence of open apices (Teeth are considered immature when a minimum of 0.8 mm apical foramen width is evident)

You may not qualify if:

  • the patients will excluded if one of the following criteria is present in the patients
  • Teeth with root fractures.
  • Presence of internal or external root resorptions.
  • Developmental anomalies of the root.
  • Presence of periapical radiolucency more than 10 mm.
  • Tooth with class III mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Alabbassia, 11566, Egypt

RECRUITING

Related Links

MeSH Terms

Interventions

Regenerative Endodontics

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • nagwa khattab, professor

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Marwa Abozed

CONTACT

00201142621411marwaabozed@dent.asu.edu.eg

mariem wassel

CONTACT

00201064871416mariem.wassel@dent.asu.edu.eg

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
Assistant Lecturer

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 23, 2023

Study Start

November 1, 2022

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

regeneration immature teeth

Locations

EG(1)