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Compares treatment options for Pulpal Necrosis
Official title Triple Antibiotic Paste vs Simvastatin for Lesion Sterilization and Tissue Repair in Primary Molars.
ClinicalTrials.gov ID: NCT07264842
What this study is testing
What is Lesion Sterilization and Tissue Repair using Simvastatin.?
Lesion Sterilization and Tissue Repair using Simvastatin. is an investigational medicine, being studied as a potential treatment for pulpal necrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This randomized, double-blinded, parallel-controlled clinical trial aims to compare the effectiveness of Triple Antibiotic Paste (TAP) and Simvastatin in Lesion Sterilization and Tissue Repair (LSTR) of primary molars with pulp necrosis. A total of 60 children (aged 5-8 years) with non-vital primary molars will be recruited from the Department of Operative Dentistry and Endodontics, Dow International Dental College, Karachi.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 8
You may be able to join if
- Young, healthy patient, ranging in age from 5-8 years.
- Has parents/ guardians who give consent to allow their minor to participate in the study and willing to monitor their progress.
- Having maxillary and mandibular primary molars with:
- Spontaneous pain or tenderness to percussion.
- Deep cavity extending to the pulp chamber.
You likely can't join if
- Uncooperative patients.
- Children with a history of allergic reaction with antibiotics.
- Teeth with physiological root resorption but root length is more than two thirds, root canal obliteration, severe internal resorption, internal...
See the full eligibility criteria
- Young, healthy patient, ranging in age from 5-8 years.
- Has parents/ guardians who give consent to allow their minor to participate in the study and willing to monitor their progress.
- Having maxillary and mandibular primary molars with:
- Spontaneous pain or tenderness to percussion.
- Deep cavity extending to the pulp chamber.
- Chronic Abscess or draining sinus.
- Restorable.
- To be kept for less than a year.
- Irregular mobility that is not related to exfoliation.
- Uncooperative patients.
- Children with a history of allergic reaction with antibiotics.
- Teeth with physiological root resorption but root length is more than two thirds, root canal obliteration, severe internal resorption, internal calcifications, or piercing into the bifurcation.
The study team makes the final eligibility decision.
Where it's taking place
- Karachi, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 8 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Karachi, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.