Clinical and Radiographic Success of Regeneration Using Injectable Platelet Rich Fibrin

NCT06086249 | Not Yet Recruiting DMC

• 1 other identifier: 102032
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study aimed at assessing the clinical and radiographic success of pulp regeneration using injectable platelet-rich fibrin in mature permanent molars with apical periodontitis versus root canal treatment using Gutta Percha (GP) obturation.

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• Clinical success

  Clinical Success is a composite outcome and will be recorded as Clinically Successful or Clinically Unsuccessful based on the following evaluation criteria: Clinically Successful: Following assigned treatment in case of absence of all of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain. Clinically unsuccessful: Following assigned treatment in case of presence of any of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain.

  1, 3, 6, 9 and 12 months

Secondary Outcomes (2)

• Radiographic success

  6 and 12 months

• Overall success

  6 and 12 months

Study Arms (2)

Regeneration using Injectable platelet-rich fibrin

EXPERIMENTAL

A 10-mL sample of whole venous blood will be drawn from the patient's forearm (median cubital vein). It will be centrifuged immediately by a tabletop centrifuge at 700 rpm for 3 minutes at room temperature. Injectable platelet-rich fibrin (I-PRF) will be collected. After that, the I-PRF will be injected inside the canals using a plastic syringe needle that will be placed 1mm short of the working length and withdrawn gradually while injecting till reaching the orifices of the canals. After that, a Collagen membrane matrix will be placed above the canal orifice and will left for 5 minutes to partially harden, then a 3 mm thick layer of MTA will be placed directly over it. The cavity will be sealed with composite and covered with a stainless steel crown.

Procedure: Regeneration using Injectable platelet-rich fibrin

Root canal treatment

ACTIVE COMPARATOR

The root canal will be obturated with gutta-percha by the cold lateral condensation technique with epoxy resin-based root canal sealer, the cavity will be sealed with composite and covered with a stainless steel crown.

Procedure: Root canal treatment

Interventions

Regeneration using Injectable platelet-rich fibrin PROCEDURE

root canals of affected molars will be cleaned and shaped chemo-mechanically, after two weeks I-PRF will be applied.

Regeneration using Injectable platelet-rich fibrin

Root canal treatment PROCEDURE

Conventional root canal treatment using gutta-percha obturation

Root canal treatment

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 10-15 years.
• First Permanent molar diagnosed with apical periodontitis.
• A cooperative and compliant patient/ parent.
• Patients not allergic to medicaments necessary to complete the procedure.
• Patients with no history of chronic systemic diseases.

You may not qualify if:

• Teeth indicated for post and core.
• Non-restorable tooth.
• Previous root canal treatment.
• Curved canal of more than 25°.
• Periodontal pocket larger than 3 mm.
• Teeth with developmental anomalies.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (10)

• Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.

  PMID: 35030270 BACKGROUND

• Rafiee A, Memarpour M, Najibi Y, Khalvati B, Kianpour S, Morowvat MH. Antimicrobial Efficacy of a Novel Antibiotic-Eluting Injectable Platelet-Rich Fibrin Scaffold against a Dual-Species Biofilm in an Infected Immature Root Canal Model. Biomed Res Int. 2020 Dec 8;2020:6623830. doi: 10.1155/2020/6623830. eCollection 2020.

  PMID: 33490247 BACKGROUND

• Aydinyurt HS, Sancak T, Taskin C, Basbugan Y, Akinci L. Effects of injectable platelet-rich fibrin in experimental periodontitis in rats. Odontology. 2021 Apr;109(2):422-432. doi: 10.1007/s10266-020-00557-1. Epub 2020 Oct 17.

  PMID: 33068206 BACKGROUND

• Taylor GD, Vernazza CR, Abdulmohsen B. Success of endodontic management of compromised first permanent molars in children: A systematic review. Int J Paediatr Dent. 2020 May;30(3):370-380. doi: 10.1111/ipd.12599. Epub 2019 Dec 13.

  PMID: 31778237 BACKGROUND

• Nageh M, Ahmed GM, El-Baz AA. Assessment of Regaining Pulp Sensibility in Mature Necrotic Teeth Using a Modified Revascularization Technique with Platelet-rich Fibrin: A Clinical Study. J Endod. 2018 Oct;44(10):1526-1533. doi: 10.1016/j.joen.2018.06.014. Epub 2018 Aug 31.

  PMID: 30174103 BACKGROUND

• Gollapudi M, Bajaj P, Oza RR. Injectable Platelet-Rich Fibrin - A Revolution in Periodontal Regeneration. Cureus. 2022 Aug 31;14(8):e28647. doi: 10.7759/cureus.28647. eCollection 2022 Aug.

  PMID: 36196318 BACKGROUND

• Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.

  PMID: 31155298 BACKGROUND

• Jha P, Virdi MS, Nain S. A Regenerative Approach for Root Canal Treatment of Mature Permanent Teeth: Comparative Evaluation with 18 Months Follow-up. Int J Clin Pediatr Dent. 2019 May-Jun;12(3):182-188. doi: 10.5005/jp-journals-10005-1616.

  PMID: 31708612 BACKGROUND

• Brizuela C, Meza G, Urrejola D, Quezada MA, Concha G, Ramirez V, Angelopoulos I, Cadiz MI, Tapia-Limonchi R, Khoury M. Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial. J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.

  PMID: 32202965 BACKGROUND

• Ibrahim LA, Tawfik MN, Naeem FMA. Evaluation of The Periapical Healing Following Pulp Revascularization Using Injectable PRF VS nonsurgical Root Canal Treatment in Mature Permanent Teeth with periapical periodontitis. A Clinical Study. Egypt Dent J. 2021;67(3):2663-2672

  BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

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: Pediatric Dentist

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 17, 2023
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share