## Protocol Section
### Identification Module
**NCT ID:** NCT06437197

**Brief Title:** Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy

**Official Title:** Clinical and Radiographic Evaluation of Platelets Rich Fibrin in Adult Pulpotomy: Randomized Clinical Trial

#### Organization Study ID Info
**ID:** 867/2992
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2024-03-23

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-18

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-12

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2023-02-09
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Al-Azhar University

#### Responsible Party

**Investigator Affiliation:** Al-Azhar University

**Investigator Full Name:** Ahmed Ibrahim Ahmed Qandeel

**Investigator Title:** Demonstrator of Endodontics, Faculty of Dental Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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:

1. Does the use of platelet rich fibrin in complete pulpotomy in mature permanent teeth will raise the success rate of full pulpotomy of adult teeth?
2. Does the use of cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs?

Participants will be asked to do the following:

* 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 Module

**Conditions:**

- Irreversible Pulpitis

**Keywords:**

- Pulpotomy

- Platelet Rich Fibrin

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pulpotomy of adult teeth using Hydraulic Calcium Silicate Cement.

**Intervention Names:**

- Procedure: Pulpotomy

**Label:** Hydraulic Calcium Silicate Cement

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Pulpotomy of adult teeth using platelet Rich fibrin.

**Intervention Names:**

- Procedure: Pulpotomy

**Label:** platelet rich fibrin (PRF)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hydraulic Calcium Silicate Cement

- platelet rich fibrin (PRF)

**Description:** Removal of the coronal pulp chamber in an adult teeth

**Name:** Pulpotomy

**Other Names:**

- Pulp amputation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Radiographic changes in periapical area using periapical radiographs.

**Time Frame:** 6 and 12 months.

#### Secondary Outcomes

**Description:** The postoperative pain was measured by modified modified Visual analog scale VAS which is is segmented into ten levels according to severity of pain, no pain (0), mild pain (1-3), moderate pain (4-6), or severe pain (7-10).

**Measure:** Postoperative pain

**Time Frame:** Immediately, 24, 48, 72 hours and 7 days.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion criteria:

1. Immature teeth.
2. Non-restorable teeth.
3. Non-vital Teeth.
4. Uncontrolled pulpal bleeding.
5. Periodontally affected teeth.

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 25 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Faculty of Dental Medicine, Al-Azhar university

**Zip:** 11651

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**Citation:** 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

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

**PMID:** 27931467

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003788

- Term: Dental Pulp Diseases

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14525

- Name: Pulpitis

- Relevance: HIGH

- As Found: Pulpitis

- ID: M6984

- Name: Dental Pulp Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011671

- Term: Pulpitis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
