Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic Paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars
LSTR
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
Lesion sterilization and tissue repair therapy technique will be used in primary molars with root resorption using Hyaluronic acid as a vehicle for the double antibiotic therapy in comparison to the conventional technique using propylene glycol vehicle
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2021
Typical duration for phase_3
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
First Submitted
Initial submission to the registry
October 3, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 11, 2021
October 1, 2021
2.1 years
October 3, 2021
October 30, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with treatment-related adverse events as assessed by clinical examination
no pain no abnormal mobility no swelling
one year
radiographic outcome assessed by comparing pre and post treatment periapical radiolucency siz
Decrease in interarticular radiolucency in size as compared to pre operative radiolucency present before treatment
one year
Study Arms (2)
hyaluronic acid group
EXPERIMENTALstudy group
propylene glycol group
OTHERcontrol group
Interventions
lesion sterilization and tissue repair technique in non vital primary molars using double antibiotic paste mixed with hyaluronic acid gel
lesion sterilization and tissue repair technique in non vital primary molars using double antibiotic paste mixed with Propylene glycol gel
Eligibility Criteria
You may qualify if:
- Patients who have a Primary molar with non-vital pulp.
- Adequate restorable tooth structure for further placement of stainless-steel crowns posttreatment.
- Inflammatory root resorption less than one half as assessed from radiographic evaluation with healthy contralateral tooth
- Teeth showing furcation radiolucency without involving the underlying tooth germ.
You may not qualify if:
- Primary molars with pulpal floor perforation.
- Patients with a history of drug allergy to metronidazole, ciprofloxacin.
- Inflammatory root resorption more than one half as assessed from radiographic evaluation with healthy contralateral tooth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amira S Badran, PhD
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assisting teacher
Study Record Dates
First Submitted
October 3, 2021
First Posted
November 11, 2021
Study Start
November 1, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
November 11, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share