Clinical trial NCT05803525: Efficacy of Combined Scaffolds and Sodium Hypochlorite in Regenerative Endodontics of Immature Teeth
Official title: كفاءة الدعامات و هيبوكلوريت الصوديوم مجتمعة في التجديد اللبى للأسنان الغير مكتملة
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incomplete Root Formation of Anterior Teeth
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: diameter of periapical radiolucency
timeFrame: 1 year
measure: diameter of root length
timeFrame: 1 year
Secondary outcomes:
measure: Pain scale
timeFrame: 1 year
measure: visual changes in discoloration
timeFrame: 1 year
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University
Study officials:
References: