Clinical trial NCT05517187: Efficacy of Regenerative Endodontic Treatment With PRF as a Secondary Treatment of Mature Necrotic Incisors in Adolescents
Official title: Clinical Success of Regenerative Endodontic Treatment With Platelets Rich Fibrin PRF as a Secondary Treatment of Mature Necrotic Incisors With Periapical Radiolucency in Adolescents: A Preliminary Parallel Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Pulp Necroses
Keywords: platelet rich fibrin
Lead sponsor: Nahda University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evalaution of clinical success of secondary treatment for total 40 permanent incisors with failed root canal treatment with apical radiolucency.

Twenty of of these permanent incisors will be treated with regenerative endodontic treatment(RET) with platelets rich fibrin PRF as intervention group vs. 20 incisors control group secondary treated with (RET) with induced blood clot (BC).

Detailed description: A preliminary randomized parallel controlled trial will be conducted. Forty teeth of 36 patients were randomly assigned into two groups: group "PRF", treated with RET with PRF platelets rich fibrin (intervention), and group "BC", treated with RET with induced blood clot(control). Upon clinical examination, the presence of pain on biting or percussion, swelling or sinus tract, or abnormal tooth mobility will be considered a failure. To monitor the changes in periapical radiolucency, a periapical index (PAI) will be used. The primary outcome of the current study will be to assess the effectiveness of RET using PRF platelets rich fibrin of mature permanent incisors with periapical radiolucency compared to RET using induced BC formation in the root canal space.

Eligibility criteria:

Healthy adolescents below the age of 18 years who need endodontic retreatment of previously obturated mature single-rooted incisors with gutta-percha will be recruited.

Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems will be precluded. Only teeth diagnosed with asymptomatic apical periodontitis or chronic apical abscess (i.e. little discomfort with intermittent episodes of pus discharge through the sinus tract) were included. To confirm the clinical status, only teeth with a periapical index (PAI) score ≥3 based on Ørstavik et al classification were considered. Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns or need post placement, or periodontal problems were excluded. A tooth must not be a candidate for endodontic surgery according to Glickman et al. indications and the updates of the European Society of Endodontology (e.g. obtaining biopsy, removal of intracanal broken files, persistent periapical lesions standing for a long period, radicular perforation, root fracture, or obstructed root canals, or the inability of complete removal of old gutta-percha or extruded material beyond the apex with persistent apical lesion for long duration).

Interventions:

According to the latest RET operating guidelines issued by the American Academy of Endodontics (AAE) and the European Society of Endodontics (ESE), the standardised operating procedure of RET requires two treatment visits. During the first appointment, infection is controlled and inflammation is relieved with complete removal of failed obturation material. Pulp regeneration and revascularization is accomplished during the second appointment.

Eligibility criteria: Inclusion Criteria:

1. Healthy patients below age of 18 years.
2. Need endodontic retreatment of previously obturated closed apexes single-rooted incisors with gutta-percha.
3. No previous attempts for endodontic retreatment.
4. Presence of clinical signs and symptoms of chronic apical periodontitis

Exclusion Criteria:

1. Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems were precluded.
2. Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns

Primary outcomes:
measure: Clinical success
timeFrame: 12 months
measure: Radiographic success
timeFrame: 12 months
Secondary outcomes:
measure: Pulp sensibility test
timeFrame: 12 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Nahda University
city: Cairo
country: Egypt
facility: Nahda
Study officials:
References: