Efficacy of Regenerative Endodontic Treatment With PRF as a Secondary Treatment of Mature Necrotic Incisors in Adolescents

NCT05517187 | Unknown

• 1 other identifier: 284
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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).

Conditions

Dental Pulp Necroses

Keywords

platelet rich fibrin

Outcome Measures

Primary Outcomes (2)

• Clinical success

  Clinical assessment will be performed at the baseline (T0) and after 12 months (T1). Upon examination, clinical failure will be encountered if one of the following features will present: (i) pain on biting or percussion, (ii) swelling or sinus tract, or (iii) abnormal tooth mobility.

  12 months

• Radiographic success

  For a standardized appraisal of the changes in the size of periapical radiolucency, long cone "paralleling technique" with a receptor holder was used after mounting a size II periapical film (Kodak International) to a silicone bite stent.

  12 months

Secondary Outcomes (1)

• Pulp sensibility test

  12 months

Study Arms (2)

Blood Clot BC (Control arm)

PLACEBO COMPARATOR

Regenerative endodontic treatment with induced Blood Clot in root canal space as a secondary treatment for failed root canal treated incisors

Other: no intervention

Platelets Rich Fibrin PRF (Intervention)

EXPERIMENTAL

Regenerative endodontic treatment with Platelet- rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors

Biological: Platelet rich fibrin

Interventions

no intervention OTHER

Regenerative endodontic treatment induced with blood clot in root canal space as a secondary treatment for failed root canal treated incisors

Blood Clot BC (Control arm)

Platelet rich fibrin BIOLOGICAL

Regenerative endodontic treatment with platelet rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors

Platelets Rich Fibrin PRF (Intervention)

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nahda University: lead

Study Sites (2)

Nahda University

Banī Suwayf, Egypt

RECRUITING

Nahda

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yassmine Farouk Mekawi, PhD

CONTACT

01006526611; yassmin.mohamed@nub.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in pediatric dentistry(clinical investigator)

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 26, 2022
• Study Start: March 10, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

EG (2)