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Evaluation of Lesion Sterilization and Tissue Repair Techniques Versus Pulpectomy in Primary Molars With Inflammed Pulp

Primary Purpose

Pulpitis - Irreversible

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lesion Sterilization and Tissue Repair with radicular instrumentation
Lesion Sterilization and Tissue Repair without radicular instrumentation
Conventional pulpectomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring LSTR, Lesion Sterilization and Tissue Repair, pulpectomy, zinc oxide and eugenol, irreversible pulpitis, vital, primary molars

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Molars should be restorable.
  • Mandibular second primary molars with deep caries, vital carious pulp exposure, irreversible pulpitis.
  • Mobility: Non or grade I.
  • Radiographic signs of minimal external root resorption.

Exclusion Criteria:

  • Children with known allergy to the agents used.
  • Children with infective endocarditis.
  • Refusal of participation.
  • Unable to attend follow-up visits.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

LSTR with radicular instrumentation.

LSTR with no radicular instrumentation.

Conventional pulpectomy.

Arm Description

Outcomes

Primary Outcome Measures

Clinical success "binary"
Absence of • Spontaneous pain. Sensitivity to percussion using dental mirror, pain on biting. Swelling. Fistula / Exudate. Mobility.
Radiographic success "binary"
Absence of • Absence of furcation or periapical radiolucency. • Absence of change in the extent of internal or external root resorption other than physiologic resorption.

Secondary Outcome Measures

Child cooperation
Continuous outcome measured on Frankl's scale immediately after the procedure.
Parental satisfaction
Binary outcome measured by direct questioning to parents. "Yes/No"
Chair side time
Continuous outcome measured in minutes using stopwatch. (After hemostasis is achieved, time will be measured with a stopwatch from the start of the three techniques till the final restoration is performed)

Full Information

First Posted
April 7, 2022
Last Updated
February 6, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05336682
Brief Title
Evaluation of Lesion Sterilization and Tissue Repair Techniques Versus Pulpectomy in Primary Molars With Inflammed Pulp
Official Title
Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair Techniques Versus Conventional Pulpectomy in Primary Molars With Inflammed Pulp A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
Group I (Experimental group I): Lesion Sterilization and Tissue Repair with radicular instrumentation. Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals. Group II (Experimental group II): Lesion Sterilization and Tissue Repair with no radicular instrumentation. Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix. Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol.
Detailed Description
The principal investigator will carry out all treatment procedures, and the patients will be assigned into three groups. For the three interventions "Two test arms and one control group": Diagnostic chart with personal, medical and dental history will be filled. Clinical examination will be performed to assess the clinical inclusion criteria. Preoperative radiographs will be taken to assess the inclusion criteria. Preoperative radiograph will serve as a reference for the follow-up radiographs. Informed consent is taken from participating parents, and they are asked to attend follow-up meetings every 3 month or whenever there is any symptom. Baseline records (personal data collection, photographs, percussion test and preoperative periapical radiographs). Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the intervention that will be used then writing patient name and I.D. on it and will be opened after performing the access cavity). Administration of Ibuprofen in age-dosage volume before administration of local anesthesia by 30 minutes to decrease pulpal pain, pain of injection and post-operative pain. Administration of local anesthesia at the side of the affected molar. Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation followed by irrigation with 2% Chlorhexidine gluconate. Ethylenediaminetetraacetic acid "EDTA" will be used to remove the smear layer leading to clean and patented dentinal tubules. Children will then be allocated into either one of the groups alternatively depending on the technique of intervention by opening a closed white envelope that is drawn for the patient. Preparation of triple antibiotic paste: The commercially available antibiotics are taken in separate dappen dishes. The enteric coating of the tablet is removed by scraping the coating with a blade, and for the capsule the outer capsular material is removed. Then each of the components is powdered separately with a clean mortar and pestle. Care should be taken to avoid wetting of powder. At this stage, the powder can be stored separately in tightly capped containers in a dark place or in the refrigerator to prevent exposure to light and moisture. After proper pulverization, each of the components is taken in a clean glass slab/mixing pad. Then a part of propylene glycol as a solvent is dispensed and mixed with equal parts of antibiotics powder to ensure uniform consistency of the mix. The final preparation will be a soft ball-like structure of 1 mm diameter. Resultant opaque paste has to be stored in airtight containers. If the mix turns translucent on storage, it has to be discarded. Group I (Experimental group I): LSTR with radicular instrumentation. Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals. Group II (Experimental group II): LSTR with no radicular instrumentation. Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix. Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE. For all groups: The molar is then restored with glass ionomer and stainless steel crown. Intraoral periapical radiographs are taken after completion of the procedure. The children are recalled for clinical evaluation at the interval of 3,6,9,12 months; and radiographic evaluation at 6,12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible
Keywords
LSTR, Lesion Sterilization and Tissue Repair, pulpectomy, zinc oxide and eugenol, irreversible pulpitis, vital, primary molars

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LSTR with radicular instrumentation.
Arm Type
Experimental
Arm Title
LSTR with no radicular instrumentation.
Arm Type
Experimental
Arm Title
Conventional pulpectomy.
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lesion Sterilization and Tissue Repair with radicular instrumentation
Intervention Description
Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and the canals.
Intervention Type
Procedure
Intervention Name(s)
Lesion Sterilization and Tissue Repair without radicular instrumentation
Intervention Description
Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.
Intervention Type
Procedure
Intervention Name(s)
Conventional pulpectomy
Intervention Description
Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE.
Primary Outcome Measure Information:
Title
Clinical success "binary"
Description
Absence of • Spontaneous pain. Sensitivity to percussion using dental mirror, pain on biting. Swelling. Fistula / Exudate. Mobility.
Time Frame
12 months
Title
Radiographic success "binary"
Description
Absence of • Absence of furcation or periapical radiolucency. • Absence of change in the extent of internal or external root resorption other than physiologic resorption.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Child cooperation
Description
Continuous outcome measured on Frankl's scale immediately after the procedure.
Time Frame
Immediately after the intervention
Title
Parental satisfaction
Description
Binary outcome measured by direct questioning to parents. "Yes/No"
Time Frame
Immediately after the intervention
Title
Chair side time
Description
Continuous outcome measured in minutes using stopwatch. (After hemostasis is achieved, time will be measured with a stopwatch from the start of the three techniques till the final restoration is performed)
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Molars should be restorable. Mandibular second primary molars with deep caries, vital carious pulp exposure, irreversible pulpitis. Mobility: Non or grade I. Radiographic signs of minimal external root resorption. Exclusion Criteria: Children with known allergy to the agents used. Children with infective endocarditis. Refusal of participation. Unable to attend follow-up visits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina H Rabea, M.Sc.
Phone
+201225114210
Email
dina.rabea@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Passant Nagi, Ph.D.
Phone
+201280557107
Email
passant.nagi@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihan M Abuelniel, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina H Rabea, M.Sc.

12. IPD Sharing Statement

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Evaluation of Lesion Sterilization and Tissue Repair Techniques Versus Pulpectomy in Primary Molars With Inflammed Pulp

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