Incomplete Root Formation of Anterior Teeth
Conditions
Brief summary
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
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 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.
Interventions
OTHERIntra-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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diameter of periapical radiolucency | 1 year | radiographic changes in root |
| diameter of root length | 1 year | radiographic changes in root |
Secondary
| Measure | Time frame |
|---|---|
| Pain scale | 1 year |
| visual changes in discoloration | 1 year |
Countries
Egypt
Contacts
Primary ContactHanan Arb, M.S.D
Backup ContactHanan Arb, M.S.D
Outcome results
None listed