Efficacy of Combined Scaffolds and Sodium Hypochlorite in Regenerative Endodontics of Immature Teeth
NCT ID: NCT05803525
Last Updated: 2023-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2020-01-15
2024-01-30
Brief Summary
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Detailed Description
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* Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution.
* Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution.
* Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution.
CBCT image will be obtained for baseline records after placement of the final resin restoration then the patients will be recalled after 6 months and 12 months for evaluating any changes in root length, root canal width, apex diameter and lesion size if present. The success rates for patients at each recall visit will be scored as follows
1. Score 0: Persistence of clinical and radiographic findings.
2. Score 1: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + no evidence of increased root dimensions.
3. Score 2: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + radiographic root development.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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• Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution.
BC will be made \& use 0.5 NaOCl conc
Intra-canal medication protocol
Copious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline.
After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points.
• Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution. •
BC will be made \& use 2.5 NaOCl conc
Intra-canal medication protocol
Copious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline.
After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points.
• Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution. •
PRF will be made \& use 0.5 NaOCl conc
Intra-canal medication protocol
Copious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline.
After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points.
Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution. •
PRF will be made \& use 2.5 NaOCl conc
Intra-canal medication protocol
Copious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline.
After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points.
• Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution.
Collagen will be made \& use 0.5 NaOCl conc
Intra-canal medication protocol
Copious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline.
After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points.
• Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution.
Collagen will be made \& use 2.5 NaOCl conc
Intra-canal medication protocol
Copious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline.
After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points.
Interventions
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Intra-canal medication protocol
Copious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline.
After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points.
Eligibility Criteria
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Inclusion Criteria
* Maxillary traumatized or cariously exposed immature anterior teeth.
* Clinical signs of pulp necrosis.
* Radiographic evidence of incomplete root development based on an apical opening \>1 mm.
Exclusion Criteria
* Non-restorable tooth.
* Radiographic evidence of root fracture.
* Lack of patient and parent cooperation.
* Teeth with vital pulps and complete root development.
* Presence of periodontal pocket \> 4 mm.
ALL
Yes
Sponsors
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Tanta University
OTHER
Responsible Party
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Hanan Mohamed Arb
Assistant professor in Endodontic department Tanta University
Locations
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Faculty of Dentistry, Tanta University
Tanta, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Hanan Arb
Role: primary
Other Identifiers
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HananArb
Identifier Type: -
Identifier Source: org_study_id
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