Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study

NCT05190783 | Completed Phase 4 DMC

• 1 other identifier: PVCPUTDMIPMACS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of the study to compare partial pulpotomy versus complete pulpotomy in primary molars using three different materials (Formocresol, MTA, Theracal LC) . After 6, 9, 12 and 15 months follow up each case will be evaluated radiographically and clinically. the radiographic criteria to be evaluated are (radiolucency, resorption, widening in periodontal ligament space, Crypt involvement) and clinical criteria are ( pain, tenderness, fistula, abnormal mobility) upon these criteria some recommendations will be made on success and failure rate of each material and each technique.

Conditions

Decayed Primary Molars

Keywords

Partial Pulpotomy; pulpotomy; MTA; Theracal; Formocresol

Outcome Measures

Primary Outcomes (1)

• post operative pain

  numerical/visual analogue scale 0 no pain 10 worst possible pain

  15 months

Secondary Outcomes (7)

• radiolucency

  15 months

• fistula

  15 months

• tooth mobility

  15 months

• tenderness

  15 months

• root resorption

  15 months

Study Arms (6)

formocresol pulpotomy

EXPERIMENTAL

gold standard arm which pulpotomy will be done with formocresol

Drug: Formocresol; Procedure: pulpotomy

formocresol partial pulpotomy

ACTIVE COMPARATOR

partial pulpotomy will be done with formocresol

Drug: Formocresol; Procedure: partial pulpotomy

MTA pulpotomy

ACTIVE COMPARATOR

in this group complete pulpotomy will be done with MTA

Drug: MTA; Procedure: pulpotomy

MTA partial pulpotomy

ACTIVE COMPARATOR

in this study group partial pulpotomy will be done with MTA

Drug: MTA; Procedure: partial pulpotomy

pulpotomy with Theracal LC

ACTIVE COMPARATOR

in this study group complete pulpotomy will be done with Theracal LC

Drug: TheraCal; Procedure: pulpotomy

partial pulpotomy with Theracal LC

ACTIVE COMPARATOR

in this study group partial pulpotomy technique will be done with Theracal LC

Drug: TheraCal; Procedure: partial pulpotomy

Interventions

Formocresol DRUG

mixture of formalin, cresol and glycerine used for fixation of pulp tissues

formocresol partial pulpotomy; formocresol pulpotomy

MTA DRUG

material used for pulp regeneration, direct and indirect pulp capping

Also known as: Mineral trioxide aggregate

MTA partial pulpotomy; MTA pulpotomy

TheraCal DRUG

light cured resin modified calcium silicate filled liner designed for use in direct and indirect pulp capping

partial pulpotomy with Theracal LC; pulpotomy with Theracal LC

pulpotomy PROCEDURE

removal of the carious tooth structure and unroofing of the pulp chamber with a round carbide bur with high speed and water spray. The coronal pulp tissue will be then removed using a #4 carbide bur with slow speed and sharp spoon excavator.

MTA pulpotomy; formocresol pulpotomy; pulpotomy with Theracal LC

partial pulpotomy PROCEDURE

complete removal of caries till exposure occurs. The exposed surface of the pulp will be gently removed using a sterile round diamond bur and a high-speed, water-cooled handpiece with light hand pressure. The removal of the pulp did not exceed approximately two mm.

MTA partial pulpotomy; formocresol partial pulpotomy; partial pulpotomy with Theracal LC

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• No history of spontaneous or nocturnal pain.
• History of transient pain of sensitivity resulting from various stimuli: hot, cold and sweets.
• Patient who had a bilateral deep carious lesion at second primary molars.
• absence of tenderness to percussion
• absence of physiologic or pathologic tooth mobility
• Radiographic evidence of no internal or external resorption.
• There is not an intraradicular or periapical bone loss or widening of the periodontal ligament space.

You may not qualify if:

• history of spontaneous or nocturnal pain.
• Patient who had a unilateral deep carious lesion.
• presence of tenderness to percussion
• presence of physiologic or pathologic tooth mobility
• Radiographic evidence of internal or external resorption.
• There is an intraradicular or periapical bone loss or widening of the periodontal ligament space.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (11)

• Smail-Faugeron V, Porot A, Muller-Bolla M, Courson F. Indirect pulp capping versus pulpotomy for treating deep carious lesions approaching the pulp in primary teeth: a systematic review. Eur J Paediatr Dent. 2016 Jun;17(2):107-12.

  PMID: 27377108 RESULT

• Katz CR, de Andrade Mdo R, Lira SS, Ramos Vieira EL, Heimer MV. The concepts of minimally invasive dentistry and its impact on clinical practice: a survey with a group of Brazilian professionals. Int Dent J. 2013 Apr;63(2):85-90. doi: 10.1111/idj.12018. Epub 2013 Mar 12.

  PMID: 23550521 RESULT

• Dhar V, Marghalani AA, Crystal YO, Kumar A, Ritwik P, Tulunoglu O, Graham L. Use of Vital Pulp Therapies in Primary Teeth with Deep Caries Lesions. Pediatr Dent. 2017 Sep 15;39(5):146-159.

  PMID: 29070150 RESULT

• Cvek M, Cleaton-Jones PE, Austin JC, Andreasen JO. Pulp reactions to exposure after experimental crown fractures or grinding in adult monkeys. J Endod. 1982 Sep;8(9):391-7. doi: 10.1016/S0099-2399(82)80092-7. No abstract available.

  PMID: 6957533 RESULT

• Schroder U, Szpringer-Nodzak M, Janicha J, Wacinska M, Budny J, Mlosek K. A one-year follow-up of partial pulpotomy and calcium hydroxide capping in primary molars. Endod Dent Traumatol. 1987 Dec;3(6):304-6. doi: 10.1111/j.1600-9657.1987.tb00639.x. No abstract available.

  PMID: 3481571 RESULT

• Parirokh M, Torabinejad M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part I: vital pulp therapy. Int Endod J. 2018 Feb;51(2):177-205. doi: 10.1111/iej.12841. Epub 2017 Sep 21.

  PMID: 28836288 RESULT

• Camp JH. Diagnosis dilemmas in vital pulp therapy: treatment for the toothache is changing, especially in young, immature teeth. J Endod. 2008 Jul;34(7 Suppl):S6-12. doi: 10.1016/j.joen.2008.03.020.

  PMID: 18565375 RESULT

• Wunsch PB, Kuhnen MM, Best AM, Brickhouse TH. Retrospective Study of the Survival Rates of Indirect Pulp Therapy Versus Different Pulpotomy Medicaments. Pediatr Dent. 2016 Oct 15;38(5):406-411.

  PMID: 28206897 RESULT

• George V, Janardhanan SK, Varma B, Kumaran P, Xavier AM. Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study). J Indian Soc Pedod Prev Dent. 2015 Apr-Jun;33(2):104-10. doi: 10.4103/0970-4388.155118.

  PMID: 25872627 RESULT

• El Meligy OA, Allazzam S, Alamoudi NM. Comparison between biodentine and formocresol for pulpotomy of primary teeth: A randomized clinical trial. Quintessence Int. 2016;47(7):571-80. doi: 10.3290/j.qi.a36095.

  PMID: 27175451 RESULT

• Poggio C, Arciola CR, Beltrami R, Monaco A, Dagna A, Lombardini M, Visai L. Cytocompatibility and antibacterial properties of capping materials. ScientificWorldJournal. 2014;2014:181945. doi: 10.1155/2014/181945. Epub 2014 May 18.

  PMID: 24959601 RESULT

MeSH Terms

Interventions

formocresol; Pemetrexed; mineral trioxide aggregate; TheraCal; Pulpotomy

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the children and their parents are blinded from the material that will be used and the technique
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: January 13, 2022
• Study Start: March 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 18, 2022

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)