Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy

NCT06437197 | Completed

• 1 other identifier: 867/2992
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional randomized clinical trial is to evaluate the use of platelet rich fibrin in full pulpotomy in mature adult teeth. The main questions it aims to answer are:

• Receive the pulpotomy treatment of their target tooth.
• Record the pain score in the pain assessment chart.
• Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target tooth. Researchers will evaluate the usage of platelet rich fibrin in performing the pulpotomy procedure of adult teeth and if cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs.

Conditions

Irreversible Pulpitis

Keywords

Pulpotomy; Platelet Rich Fibrin

Outcome Measures

Primary Outcomes (1)

• Radiographic changes in periapical area using periapical radiographs.

  The radiographic changes was evaluated using periapical radiographs. the outcome was measured using the periapical index scoring 1,2,3,4 or 5 with 1 indicating normal and 5 indicates severe periodontitis with exacerbating features.

  6 and 12 months.

Secondary Outcomes (1)

• Postoperative pain

  Immediately, 24, 48, 72 hours and 7 days.

Study Arms (2)

Hydraulic Calcium Silicate Cement

ACTIVE COMPARATOR

Pulpotomy of adult teeth using Hydraulic Calcium Silicate Cement.

Procedure: Pulpotomy

platelet rich fibrin (PRF)

EXPERIMENTAL

Pulpotomy of adult teeth using platelet Rich fibrin.

Procedure: Pulpotomy

Interventions

Pulpotomy PROCEDURE

Removal of the coronal pulp chamber in an adult teeth

Also known as: Pulp amputation

Hydraulic Calcium Silicate Cement; platelet rich fibrin (PRF)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age: 25-35 years
• Mature permanent premolar teeth with two separate roots.
• Clinical diagnosis of irreversible pulpitis.
• Patients without existing medical condition.

You may not qualify if:

• Immature teeth.
• Non-restorable teeth.
• Non-vital Teeth.
• Uncontrolled pulpal bleeding.
• Periodontally affected teeth.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine, Al-Azhar university

Cairo, 11651, Egypt

Location

Related Publications (19)

• Iaculli F, Rodriguez-Lozano FJ, Briseno-Marroquin B, Wolf TG, Spagnuolo G, Rengo S. Vital Pulp Therapy of Permanent Teeth with Reversible or Irreversible Pulpitis: An Overview of the Literature. J Clin Med. 2022 Jul 11;11(14):4016. doi: 10.3390/jcm11144016.

  PMID: 35887779 BACKGROUND

• Hanna SN, Perez Alfayate R, Prichard J. Vital Pulp Therapy an Insight Over the Available Literature and Future Expectations. Eur Endod J. 2020 Mar 1;5(1):46-53. doi: 10.14744/eej.2019.44154. eCollection 2020.

  PMID: 32342038 BACKGROUND

• Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. No abstract available.

  PMID: 27931467 BACKGROUND

• AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.

  PMID: 34352305 BACKGROUND

• Cervino G, Laino L, D'Amico C, Russo D, Nucci L, Amoroso G, Gorassini F, Tepedino M, Terranova A, Gambino D, Mastroieni R, Tozum MD, Fiorillo L. Mineral Trioxide Aggregate Applications in Endodontics: A Review. Eur J Dent. 2020 Oct;14(4):683-691. doi: 10.1055/s-0040-1713073. Epub 2020 Jul 29.

  PMID: 32726858 BACKGROUND

• Cushley S, Duncan HF, Lappin MJ, Tomson PL, Lundy FT, Cooper P, Clarke M, El Karim IA. Pulpotomy for mature carious teeth with symptoms of irreversible pulpitis: A systematic review. J Dent. 2019 Sep;88:103158. doi: 10.1016/j.jdent.2019.06.005. Epub 2019 Jun 20.

  PMID: 31229496 BACKGROUND

• Linsuwanont P, Wimonsutthikul K, Pothimoke U, Santiwong B. Treatment Outcomes of Mineral Trioxide Aggregate Pulpotomy in Vital Permanent Teeth with Carious Pulp Exposure: The Retrospective Study. J Endod. 2017 Feb;43(2):225-230. doi: 10.1016/j.joen.2016.10.027. Epub 2016 Dec 29.

  PMID: 28041685 BACKGROUND

• Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.

  PMID: 26841969 BACKGROUND

• Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.

  PMID: 28673494 BACKGROUND

• Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.

  PMID: 30292451 BACKGROUND

• Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.

  PMID: 34854987 BACKGROUND

• Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.

  PMID: 16504852 BACKGROUND

• Borie E, Olivi DG, Orsi IA, Garlet K, Weber B, Beltran V, Fuentes R. Platelet-rich fibrin application in dentistry: a literature review. Int J Clin Exp Med. 2015 May 15;8(5):7922-9. eCollection 2015.

  PMID: 26221349 BACKGROUND

• Patidar S, Kalra N, Khatri A, Tyagi R. Clinical and radiographic comparison of platelet-rich fibrin and mineral trioxide aggregate as pulpotomy agents in primary molars. J Indian Soc Pedod Prev Dent. 2017 Oct-Dec;35(4):367-373. doi: 10.4103/JISPPD.JISPPD_178_17.

  PMID: 28914251 BACKGROUND

• Eid A, Mancino D, Rekab MS, Haikel Y, Kharouf N. Effectiveness of Three Agents in Pulpotomy Treatment of Permanent Molars with Incomplete Root Development: A Randomized Controlled Trial. Healthcare (Basel). 2022 Feb 25;10(3):431. doi: 10.3390/healthcare10030431.

  PMID: 35326909 BACKGROUND

• Keswani D, Pandey RK, Ansari A, Gupta S. Comparative evaluation of platelet-rich fibrin and mineral trioxide aggregate as pulpotomy agents in permanent teeth with incomplete root development: a randomized controlled trial. J Endod. 2014 May;40(5):599-605. doi: 10.1016/j.joen.2014.01.009. Epub 2014 Mar 6.

  PMID: 24767550 BACKGROUND

• Noor Mohamed R, Basha S, Al-Thomali Y. Efficacy of platelet concentrates in pulpotomy - a systematic review. Platelets. 2018 Jul;29(5):440-445. doi: 10.1080/09537104.2018.1445844. Epub 2018 Mar 14.

  PMID: 29537945 BACKGROUND

• Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.

  PMID: 27994420 BACKGROUND

• Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.

  PMID: 24049221 BACKGROUND

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of Endodontics, Faculty of Dental Medicine

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: May 31, 2024
• Study Start: March 12, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 23, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)