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Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Teeth

Primary Purpose

Apical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Method
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • Abanoub Raouf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Blood clotting

Disinfection technique

Arm Description

Blood clotting protocol for pulp regeneration of mature teeth

Compare different disinfection technique

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Radiographic success
healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption

Full Information

First Posted
September 24, 2022
Last Updated
September 24, 2022
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05557994
Brief Title
Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Teeth
Official Title
Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood clotting
Arm Type
Active Comparator
Arm Description
Blood clotting protocol for pulp regeneration of mature teeth
Arm Title
Disinfection technique
Arm Type
Experimental
Arm Description
Compare different disinfection technique
Intervention Type
Other
Intervention Name(s)
Method
Intervention Description
treatment of mature teeth with apical periodontitis
Primary Outcome Measure Information:
Title
Clinical success
Description
pulp vitality testing using electric pulp tester which detect response of pulp to electric current
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Radiographic success
Description
healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Facility Information:
Facility Name
Abanoub Raouf
City
Banī Suwayf
State/Province
Bani Suwayf
ZIP/Postal Code
082
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Teeth

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