NCT05557994

Brief Summary

Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. The aim of this study is to assess the regenerative potential of mature permanent teethwith necrotic pulps after disinfecting the root canal using diode laser andcompare it with dynamic agitation of xp-endo finisher and conventionaltriple antibiotic paste

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

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

June 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 24, 2022

Last Update Submit

September 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical success

    pulp vitality testing using electric pulp tester which detect response of pulp to electric current

    9 months

Secondary Outcomes (1)

  • Radiographic success

    9 months

Study Arms (2)

Blood clotting

ACTIVE COMPARATOR

Blood clotting protocol for pulp regeneration of mature teeth

Other: Method

Disinfection technique

EXPERIMENTAL

Compare different disinfection technique

Other: Method

Interventions

MethodOTHER

treatment of mature teeth with apical periodontitis

Blood clottingDisinfection technique

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with mature teeth. Patients with periapical periodontitis. Maxillary anterior teeth only will be involved. Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  • Patients who will agree to the consent and will commit to follow up period.

You may not qualify if:

  • Patients with immature roots. - Immuno-compromised patients, including patients who self-reportedto be a carrier of HIV, hepatitis, undergoing steroid therapy, thosewho self-reported with genetic or systemic diseases that could resultin a reduced immune response.- All patients who respond positive to allergic patch test \[tripleantibiotic paste\] and drugs.- Pregnant and lactating women.- Patients who could/would not participate in a 1-year follow-up.- Teeth with previous endodontic therapy performed. - Teeth with periodontal involvement. - Teeth with calcified canals.- Presence of external or internal root resorption.- Teeth with root fractures (checked with pre-operative radiographsusing horizontal and vertical angulations)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abanoub Raouf

Banī Suwayf, Beni Suweif Governorate, 082, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Methods

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

Investigative Techniques

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

September 24, 2022

First Posted

September 28, 2022

Study Start

June 15, 2021

Primary Completion

June 15, 2022

Study Completion

July 20, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations