Efficacy of Combined Scaffolds and Sodium Hypochlorite in Regenerative Endodontics of Immature Teeth

Study Overview
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Brief Summary
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The aim of the study is to evaluate the efficacy of combinations of different scaffolds (blood clot, platelet rich fibrin, collagen) and sodium hypochlorite concentrations (0.5%- 2.5%) in regenerative endodontics of immature non-vital anterior teeth clinically and radiographically using cone-beam computed tomography.

Detailed Description
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Patients will be divided randomly into six equal groups (n=8) 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 Score 0: Persistence of clinical and radiographic findings. Score 1: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + no evidence of increased root dimensions. Score 2: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + radiographic root development.

Official Title
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كفاءة الدعامات و هيبوكلوريت الصوديوم مجتمعة في التجديد اللبى للأسنان الغير مكتملة

Conditions
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Incomplete Root Formation of Anterior Teeth

Intervention / Treatment
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* Other: Intra-canal medication protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients, abarantly free from any systemic diseases that may hinder the normal healing process. 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: • Allergy to medication used in the procedure or any medical conditions that contraindicate endodontic treatment (eg, acute systemic disease and abnormalities in host defense). 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: • Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution.<br>BC will be made & use 0.5 NaOCl conc | Other: Intra-canal medication protocol<br>* 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.<br>|
| Active Comparator: • Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution. •<br>BC will be made & use 2.5 NaOCl conc | Other: Intra-canal medication protocol<br>* 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.<br>|
| Active Comparator: • Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution. •<br>PRF will be made & use 0.5 NaOCl conc | Other: Intra-canal medication protocol<br>* 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.<br>|
| Active Comparator: Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution. •<br>PRF will be made & use 2.5 NaOCl conc | Other: Intra-canal medication protocol<br>* 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.<br>|
| Active Comparator: • Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution.<br>Collagen will be made & use 0.5 NaOCl conc | Other: Intra-canal medication protocol<br>* 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.<br>|
| Active Comparator: • Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution.<br>Collagen will be made & use 2.5 NaOCl conc | Other: Intra-canal medication protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diameter of periapical radiolucency | radiographic changes in root | 1 year | 
| diameter of root length | radiographic changes in root | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale |  | 1 year | 
| visual changes in discoloration |  | 1 year |