Pulpotomy Versus Pulpectomy in Vital Primary Incisors

NCT05589025 | Completed

• 1 other identifier: 14154
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this split mouth randomized controlled study was to compare formocresol pulpotomy and zinc-oxide and eugenol pulpectomy in the treatment of vital pulp exposure in primary incisor. 39 Contralateral pairs of incisors were randomly assigned to receive pulpotomy or pulpectomy in children aged from 18 to 66 months old. Clinical and radiographical evaluations were performed at 6 and 12 months

Conditions

Dental Caries; Pulp Disease, Dental

Keywords

pulpotomy; pulpectomy; tooth, deciduous

Outcome Measures

Primary Outcomes (2)

• clinical failure

  composite outcome including pain, soft tissue pathology, and tooth mobility. All are binary outcomes. The presence of any item is recorded as a clinical failure.

  1 year

• radiographic failure

  a composite outcome including pathologic mobility and pathologic root resorption. Both are binry outcomes, the presence of any of them is recorded as a radiographic failure.

  1 year

Secondary Outcomes (1)

• survival rate

  1 year

Study Arms (2)

treatment group

ACTIVE COMPARATOR

pulpotomy: amputation of coronal pulp

Procedure: pulpotomy technique with formocresol

control group

ACTIVE COMPARATOR

Pulpectomy: complete removal of the pulp tissues from the canals

Procedure: pulpectomy technique with zinc oxide and eugenol

Interventions

pulpotomy technique with formocresol PROCEDURE

The pulpotomy procedure performed was a modification of that described by Pinkham et al; 2005 where pulp chamber was unroofed using a no. 330 sterile bur in a water-cooled high-speed handpiece. The entire roof of pulp chamber and overhanging dentinal remnants over the pulp horns were removed. After the completion of the access cavity, coronal pulp was extirpated using a sharp excavator. Any residual coronal pulpal tissue was removed using a sterile round bur in a slow-speed handpiece to a depth of few millimeters below the free gingival margin. Hemostasis was achieved with a water-dampened cotton pellet. If hemostasis was not achieved after the initial application of the cotton pellet, the case was eliminated from the study. Following hemostasis, a cotton pellet, moistened with formocresol was applied for 3 minutes and removed. A zinc- oxide and eugenol base was placed over the amputation site. Thereafter, a glass ionomer base was applied.

Also known as: vital pulp therapy

treatment group

pulpectomy technique with zinc oxide and eugenol PROCEDURE

The pulpectomy procedure used herein was a modification of that described by Payne et al;1993 Pulp chamber was unroofed using a no. 330 sterile bur in a water-cooled high-speed handpiece. The entire roof of pulp chamber and overhanging dentinal remnants over the pulp horns were removed. An initial endodontic K-file fitting snugly in the canal was introduced inside it. In most cases, the pulp tissue was removed completely on the first attempt. If the first attempt was unsuccessful, the procedure was repeated and canals were generally enlarged three sizes past the initial file to eliminate the organic remnants. Copious irrigation with a light flow of sterile 0.9% NaCl-solution was used throughout the procedure. At the end, the canals were dried and filled with zinc-oxide \& eugenol.

Also known as: root canal treatment

control group

Eligibility Criteria

• Age: 18 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Two or more carious vital primary maxillary incisors where exposure of the vital pulp following the removal of dental caries was inevitable.
• No history of spontaneous pain
• No lingering provoked pain
• No pain on percussion, No fistula, or sinus tract
• No history of trauma
• No periapical radiolucency
• No pathologic root resorption
• No pulp calcification.

You may not qualify if:

• Teeth with physiologic resorption exceeding one-third of the root
• Teeth non-restorable with crowns.

Sponsors & Collaborators

• National Research Centre, Egypt: lead
• Cairo University: collaborator

Related Publications (4)

• Howley B, Seale NS, McWhorter AG, Kerins C, Boozer KB, Lindsey D. Pulpotomy versus pulpectomy for carious vital primary incisors: randomized controlled trial. Pediatr Dent. 2012 Sep-Oct;34(5):112-9.

  PMID: 23211895 BACKGROUND

• Aminabadi NA, Farahani RM, Gajan EB. A clinical study of formocresol pulpotomy versus root canal therapy of vital primary incisors. J Clin Pediatr Dent. 2008 Spring;32(3):211-4. doi: 10.17796/jcpd.32.3.ghk26v4554790074.

  PMID: 18524271 BACKGROUND

• Smail-Faugeron V, Fron Chabouis H, Durieux P, Attal JP, Muller-Bolla M, Courson F. Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children. PLoS One. 2013;8(1):e51908. doi: 10.1371/journal.pone.0051908. Epub 2013 Jan 3.

  PMID: 23300955 BACKGROUND

• Gadallah LK, Elbardissy A, Elyazeed MA, Alsamad AA, Hamdy M. Pulpotomy versus pulpectomy in carious vital pulp exposure in primary incisors: a randomized controlled trial. BMC Oral Health. 2024 Mar 20;24(1):354. doi: 10.1186/s12903-024-04116-w.

  PMID: 38504243 DERIVED

MeSH Terms

Conditions

Dental Caries; Dental Pulp Diseases

Interventions

formocresol; Zinc Oxide; Eugenol

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds; Caffeic Acids; Cinnamates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Allylbenzene Derivatives; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Lamia Gadallah, Researcher

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: blinding of assessor of clinical outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: split mouth

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 21, 2022
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 15, 2016
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share