Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
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ClinicalTrials.gov Identifier: NCT01976065 |
Recruitment Status :
Completed
First Posted : November 5, 2013
Last Update Posted : September 7, 2023
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Condition or disease | Intervention/treatment | Phase |
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Pulp Necrosis Regeneration | Drug: Triple Antibiotic Paste Other: Standard Treatment | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots |
Actual Study Start Date : | September 2014 |
Actual Primary Completion Date : | September 24, 2018 |
Actual Study Completion Date : | September 24, 2018 |
Arm | Intervention/treatment |
---|---|
Mineral Trioxide Aggregate (MTA)
Standard Treatment group consisting of placement of Mineral Trioxide Aggregate (MTA), an FDA approved dental material at the end of an immature root followed by a composite restoration (crown).
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Other: Standard Treatment
Standard Treatment no use of study drug
Other Name: No use of study drug |
Experimental: Revascularization Treatment (REVASC)
Consists of standard treatment procedure PLUS disinfection of the canal space with Triple Antibiotic Paste study medication followed by placement of Collaplug, an FDA approved material to help promote clotting. A composite restoration in then placed.
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Drug: Triple Antibiotic Paste
USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency
Other Name: Ciprofloxacin, Metronidazole, & Minocycline |
Experimental: Regeneration Treatment (REGENDO)
Consists of standard treatment procedure PLUS Triple Antibiotic Paste study medication PLUS use of Emdogain, an FDA approved medication used in an FDA approved manner, that is a growth factor to help surrounding tissues to grow together and heal.
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Drug: Triple Antibiotic Paste
USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency
Other Name: Ciprofloxacin, Metronidazole, & Minocycline |
- Tooth Survival [ Time Frame: 2 years ]1) the growth in hard tissue deposition in the radiographic root area is increased by at least 20%, and 2) the tooth survives to this time point and 3) there is no pain.
- Positive pulpal response [ Time Frame: 2 years ]Comparison of treatment effects on positive pulpal responses, crown staining, preoperative factors (age, sex, history of trauma), or antimicrobial efficacy and residual intracanal microbial load would influence the primary outcome measure of tooth survival.
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Ages Eligible for Study: | 6 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 6-20
- Participant has a permanent tooth with a necrotic pulp (as defined by lack of responsiveness to both electrical pulp tests and cold [EndoIce] tests). If the tooth was traumatized, then pulpal necrosis is defined as either: 1) no response to both electrical pulp test and cold [EndoIce] test by three months after trauma, or 2) presence of a periapical lesion, or 3) radiographic evidence of root resorption, or 4) discoloration of the crown.
- Tooth in question is restorable (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown.
- Incomplete (i.e., immature) root development defined by apical foramen ≥1.0mm (each foramina >1.0mm for multi-rooted teeth).
- At least 5 mm of root development (CEJ to radiographic apex).
- Willing and able to provide informed assent/consent.
- Legal guardian willing and able to provide informed consent.
Exclusion Criteria:
- No access to telephone for study contacts.
- Unable to comprehend study materials in English or Spanish.
- Subject not available for follow up at 12 or 24 months.
- Previous allergic response to ciprofloxacin, metronidazole or minocycline or any materials used in the study.
- History of systemic diseases with altered immune function including diabetes, immunodeficiency, leukemia, Addison's or Cushing's disease.
- History of taking immunosuppressants or chemotherapeutic agents including glucocorticoids in the past 3 months.
- Clinical or radiographic evidence of root fracture or alveolar fracture.
- Tooth in question received prior endodontic obturation.
- Tooth in question has class III mobility or dens invaginatus.
- Tooth in question has a history of avulsion with extra-oral dry time longer than 1 hour.
- Clinical judgement (with documentation of the reason)
- Radiographic or clinical identification of ankylosis (replacement resorption) or inflammatory (infection-related) root resorption.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976065
United States, California | |
Loma Linda University | |
Loma Linda, California, United States, 92350 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Texas | |
University of Texas Health Science Center | |
San Antonio, Texas, United States, 78229 |
Study Chair: | Kenneth Hargreaves, DDS, PhD | University of Texas |
Responsible Party: | Kenneth Hargreaves, Chair, Dept. of Endodontics, UTHSCSA, The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT01976065 |
Other Study ID Numbers: |
HSC20130467H |
First Posted: | November 5, 2013 Key Record Dates |
Last Update Posted: | September 7, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No plan to share data at this time. |
Necrotic tooth pulp Immature permanent teeth Regeneration |
Dental Pulp Necrosis Necrosis Pathologic Processes Dental Pulp Diseases Tooth Diseases Stomatognathic Diseases Anti-Bacterial Agents Metronidazole Ciprofloxacin Minocycline |
Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |